Pharmaceutical Sciences Jobs in Usa

Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radio antibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radio antibodies precisely target cancer cells with potent, localized radiation.

In addition to the roles and responsibilities outlined below, we value team members who are eager to make an impact and grow with us professionally. We are seeking an individual who enjoys multi-tasking and has the willingness and flexibility to assume additional responsibilities as assigned.

Location: 50 Milk Street, Boston, MA

Reporting to: Caitlyn Harvey, SVP of Technical Operations

Responsibilities

• Use your understanding of drug product life cycle management to strategically identify CIPs based on need.
• Lead technology transfers and author technical documents including reports, standard operating procedures, master batch records, work instructions
• Collaborate with the Development Lead to learn and document the process as well as co-author development protocols and development technical reports.
• Author key IND updates and justifications
• Provide onsite support at the CDMO, develop a training plan for manufacturing operators, and oversee process execution
• Review executed batch records, collaborate with QA to close process deviations, analyze manufacturing trends, and recommend improvements
• Lead investigations to troubleshoot process execution challenges including RCA
• Demonstrate ability to engage and effectively influence team members across multidisciplinary teams while prioritizing multiple projects and meeting deadlines
• Drive curiosity, scientific rigor and excellent problem-solving skills across a fast-paced performance driven environment

Requirements

• BS and/or MS in Chemical, Biological, or Biomedical Engineering plus 10 yrs or equivalent combination of education and work experience
• Experience authoring IND sections
• Previous experience with antibody based drug substances
• Detail-oriented with good problem-solving, technical writing and verbal communication skills
• Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects
• Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment
• Well versed with cGMP requirements and working in a regulated environment, including experience as person-in-plan and/or GMP operator.
• Working knowledge of statistical design of experiments (DoE) and RCA.
• Excellent technical writing skills
• Ability to travel up to 25% of the time
• This is a Hybrid role, in office 2 to 3 days a week
• We are considering Greater Boston based candidates only

Nice to haves:

• Knowledge of radiochemistry
• Understanding of analytical methods such as HPLC
• Experience developing scale down models

Equal Opportunity Employer

We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment, including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. We will make reasonable accommodation for qualified individuals in accordance with applicable law.

Kelly® Science & Clinical is seeking a Process Engineering Manager for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Colorado Springs, CO facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Workplace: Onsite in Colorado Springs, CO

Position Title: Process Engineering Manager, Oral Dosage Forms

Position Type: Direct hire

Salary: $125,000-140,000

Are you ready to drive innovation and success in pharmaceutical manufacturing? We are seeking a dynamic Principal Investigator to serve as a technical authority in process development, scale-up, and technology transfer. If you thrive in collaborative, fast-paced environments and are passionate about advancing life-changing therapies, this is your opportunity to make a significant impact.

Responsibilities

Strategic Process Development & Scale-Up

• Spearhead the development and scale-up of robust, scalable manufacturing processes across a wide spectrum of drug products
• Design and lead process characterization and optimization studies, defining critical process parameters and proven acceptable ranges
• Champion Quality by Design (QbD) strategies and advanced statistical methodologies, ensuring seamless progression from laboratory concepts to pilot-scale execution

Technology Transfer Leadership

• Serve as the technical lead for all technology transfer activities, bridging R&D, global manufacturing sites, and client partners
• Develop and implement comprehensive transfer protocols and process equivalence strategies to ensure flawless execution
• Lead high-performing, cross-functional teams through knowledge transfer, process mapping, and documentation best practices

Pilot Plant & cGMP Operations Management

• Oversee cGMP-compliant pilot plant operations, supporting clinical and commercial production, validation, and process improvement
• Drive continuous improvement projects—maximizing efficiency, quality, and yield
• Provide expert troubleshooting and manage deviations, ensuring on-time project delivery

Capital Projects & Facility Optimization

• Lead equipment qualification and validation for cutting-edge process installations
• Direct facility expansion and modification projects to support innovation and new technology implementation
• Optimize facility workflows to enhance operational excellence and scalability

Quality Assurance & Regulatory Compliance

• Ensure strict adherence to cGMP (21 CFR 210/211) and data integrity (21 CFR 11) regulations
• Develop and execute robust process validation strategies in accordance with global regulatory standards
• Lead investigations, implement corrective/preventive actions, and maintain perpetual audit readiness

Project Management & Client Engagement

• Manage multiple, high-profile client technology transfer programs—delivering on time and within budget
• Serve as the primary technical liaison for clients, providing strategic insight and technical guidance
• Develop detailed project plans, risk assessments, and contingency strategies to de-risk tech transfer activities
• Mentor cross-functional teams, fostering a culture of excellence and innovation

Qualifications

Education:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/PhD) preferred

Experience:

• 8+ years’ experience (Bachelor’s), 5+ years (MS), or 3+ years (PhD) in pharmaceutical process development, technology transfer, and scale-up within a CDMO or CRO environment
• Demonstrated success managing complex, cross-functional projects in a regulated setting

Technical Mastery

• Deep expertise in pharmaceutical process engineering, manufacturing technologies, process validation, and equipment qualification
• Comprehensive understanding of cGMP, quality systems, and regulatory compliance
• Proven skills in process automation, risk management, and project execution

Leadership & Collaboration

• Recognized leadership in guiding technical teams and cross-functional project groups
• Outstanding client relationship management and communication abilities
• Strategic thinker with a results-driven mentality, adept at navigating complex challenges and inspiring teams

Why Join Us?

• Work alongside industry leaders and innovators
• Participate in high-impact projects accelerating life-saving therapies to market
• Competitive salary, comprehensive benefits, and opportunities for continued professional growth

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

Summary:

The Head of Production (Sterile Injectables) is responsible for providing strategic and operational leadership for all aspects of sterile manufacturing operations. This role ensures compliance with cGMP regulations, drives operational excellence, and leads high-performing teams to achieve manufacturing objectives in a regulated environment.

Responsibilities:

• Direct and oversee all sterile manufacturing operations, including component preparation, formulation, compounding, aseptic filling, visual inspection, and packaging.
• Develop and implement production strategies to achieve manufacturing goals, supply commitments, and performance targets.
• Ensure all manufacturing activities adhere to cGMP regulations, internal quality systems, and regulatory requirements for sterile drug products.
• Maintain a continuous state of audit readiness and support regulatory inspections, internal audits, and customer audits.
• Lead and manage investigations, deviations, CAPAs, and change control processes impacting production operations.
• Establish, monitor, and report on key performance indicators (KPIs) related to safety, quality, delivery, and productivity to drive accountability and improvement.
• Champion operational excellence initiatives to enhance manufacturing efficiency, reduce waste, and improve process reliability.
• Build, develop, and lead high-performing production teams, fostering a culture of compliance, safety, and continuous improvement.

Qualifications:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field required; Master’s degree preferred.
• 8–15 years of progressive experience in pharmaceutical manufacturing operations within a regulated cGMP environment.
• 5–12 years of leadership experience in sterile or aseptic pharmaceutical manufacturing settings.
• Proven experience overseeing operations such as formulation, compounding, aseptic filling, visual inspection, and/or packaging of pharmaceuticals.
• Strong knowledge of FDA cGMP regulations and regulatory expectations for sterile drug product manufacturing.
• Experience supporting regulatory inspections and maintaining audit-ready operations.
• Demonstrated ability to lead investigations, manage deviations, CAPAs, and change control activities.
• Proven leadership skills with experience developing and managing production teams in regulated environments.

Role Overview

The Key Account Manager (KAM) is responsible for managing and expanding Pion’s most

strategic customer relationships within the Boston market. This role is central to the

company’s growth strategy and carries meaningful ownership over revenue performance,

account expansion and long-term customer value.

The KAM operates with a high degree of autonomy and accountability, working in a

performance-driven environment where accurate forecasting, structured account

planning, and disciplined execution are essential. This is not a transactional sales role - it

requires strategic thinking, scientific credibility and operational rigor.

Key Responsibilities

Strategic Account Management

 Own and execute comprehensive account plans aligned to company growth targets

 Build deep, multi-level relationships across R&D, Analytical, CMC and Procurement

 Understand customer workflows, strategic priorities, and long-term pipelines

 Position Pion as a long-term partner through value-based, consultative engagement

 Identify expansion opportunities tied to new applications, enhanced products and

evolving customer needs

Sales Execution & Growth

 Deliver against defined revenue and growth objectives for assigned territory

 Manage complex sales cycles involving capital equipment, consumables and

services

 Maintain disciplined pipeline management, opportunity qualification and

forecasting

 Ensure CRM accuracy and timely updates to support operational planning and

leadership visibility

 Set and manage customer expectations around manufacturing schedules, lead

times and delivery constraints

Operational Excellence & Rigor

 Operate with a high level of structure, accountability and follow-through

 Partner closely with Operations, Manufacturing, Applications, and Service to drive

predictable outcomes

 Proactively identify risks and constraints, escalating appropriately and early

 Contribute to continuous improvement of sales processes, tools, and cadence

Customer Advocacy & Internal Collaboration

 Serve as the primary commercial owner for assigned territory accounts

 Coordinate internal resources to ensure successful installations, adoption and

ongoing value realization

 Act as the voice of the customer, providing actionable feedback to Product and

Leadership teams

 Navigate escalations and competitive pressures with professionalism and clarity

Market & Competitive Insight

 Maintain strong awareness of regional market dynamics, competitors and emerging

technologies

 Represent Pion customer meetings, scientific forums and industry events

 Identify high-growth opportunities within pharma, biotech, CDMOs and academic

institutions in the Boston ecosystem

Qualifications & Experience

Required

 Advanced degree in Chemistry, Pharmaceutical Sciences, Engineering or a related

scientific discipline preferred

 5+ years of experience in life sciences sales

 Demonstrated success managing complex, high-value strategic accounts

 Strong understanding of drug development workflows

 Ability to operate e􀆯ectively in a performance-driven, growth-oriented environment

 Strong organizational skills with a track record of operational discipline and

execution

 Willingness to travel regionally and occasionally nationally

Preferred

 Experience selling analytical instrumentation or pharmaceutical enabling

technologies

 Familiarity with capital equipment sales cycles

 MBA or advanced scientific degree

 Experience working cross-functionally within a global organization

What Success Looks Like

 Measurable contribution to Pion’s strategic growth targets

 Strong penetration and expansion within assigned key accounts

 Accurate forecasting and disciplined account management

 High customer trust and long-term partnership development

 Consistent demonstration of operational excellence and accountability

Why Join Pion

 Be part of a respected scientific company entering an exciting new growth phase

 Work with enhanced technologies that are expanding Pion’s impact in drug

development

 Operate in a role where individual performance directly influences company

success

 Collaborate with a knowledgeable, committed team focused on execution and

results

 Competitive compensation, incentive plan and benefits

• Strategic Leadership:
  • Able to define a vision for a site of approximately 200 staff members, including the development of a 3 to 5 year operating plan
  • Prior experience managing responsibility of the P&L and balance sheet for a manufacturing site.
  • Deliver annual revenue, profit, EBITDA, and cash targets through effective P&L management.
  • Execute capital projects on average of +$10M to ensure facilities, equipment, and systems meet production demand and compliance requirements.
  • Develop and execute site master plan which includes building talent capabilities that results in the site meeting branded large pharma industry standards to facilitate new business.
• Regulatory & Compliance:
  • Ensure strict adherence to cGMP, FDA, and DEA regulations for controlled substances.
  • Maintain FDA audit readiness and compliance with OSHA, EPA, DEA and other regulatory agencies.
• Process Excellence & Operational Performance:
  • Drive process improvement initiatives, lean manufacturing, and digital transformation to optimize throughput and reduce costs.
  • Assess site operations and drive execution of cost reduction initiatives to improve productivity and profitability of products
  • Implement best practices for manufacturing
  • Deep understanding in Process Safety Management, Environmental understanding, including wastewater treatment plant operations and security programs.
  • Oversee ERP and compliance systems (including D365) for operational efficiency.
• Commercial & Customer Focus:
  • Partner with Commercial teams to define and execute strategies for revenue growth and customer satisfaction.
  • Ensure timely delivery of products in compliance with regulatory requirements.
• People Leadership:
  • Recruit, develop, and retain high-caliber talent through succession planning and performance management.
  • Demonstrates deep understanding on cultural transformation
  • Foster a culture of engagement, accountability, and continuous improvement.
• Business Development:
  • Enable the site to deliver late -phase/commercial CDMO programs that include the acquisition of new customers, tech transfer and scale up production.
  • Participate in strategic initiatives including market expansion, technology alliances, and evaluation of new products.
  • Support acquisition and rationalization activities as needed.
    
    

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or related field (advanced degree preferred).
  
  

• 15+ years in API small molecules pharmaceutical manufacturing leadership roles, with proven expertise in cGMP, FDA, and DEA compliance for APIs and controlled substances.
• Proven experience in generics manufacturing with knowledge and capabilities to meet big pharma branded business.
• Demonstrated success in operational turnarounds, quality remediations, or start-up of manufacturing facilities.
• Strong background in process optimization and continuous improvement methodologies.
  
  

• Exceptional leadership, communication, and change management skills.
• Detail oriented, advance analytical capabilities and high learning agility
• Ability to manage complex operations and deliver results in a dynamic environment.
• Understanding transactional process improvements
• Understand how to develop and implement operating mechanism and meeting structure to manage operations at the site, including the definition and implementation of KPIs and tier meetings.
  
  

• Health & Wellness: Comprehensive health & wellness benefits. Access to mental health resources and wellness programs. Generous PTO and holiday pay policies.
• Financial Wellness: Veranova is committed to fair and transparent compensation practices. This includes a competitive base salary, eligibility for performance-based bonuses, and an attractive 401(k) Plan with company match. Salary ranges reflect the scope and expectations of the role, and are based on market data, internal equity, and role-specific factors. Final compensation may vary depending on experience, skills, education, and business needs.
• Professional Development: Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship. Tuition Assistance for Undergraduate and Graduate degree programs.
• Inclusive Culture: At Veranova, an inclusive culture is integral to our values. We welcome people with diverse experiences and perspectives who share our mission to improve and save lives. Even if you do not meet every qualification, we encourage you to apply. Veterans, first responders, and those transitioning from military to civilian life bring valuable skills that strengthen our team.
  
  

Founded in 1984, Best Formulations LLC, a diversified nutraceutical and personal care company headquartered in City of Industry, California, is a contract manufacturer of thousands of branded SKUs, including high quality nutritional supplements. At the core of our ethos is a dedication to personal care, where every product is crafted with meticulous attention to detail and the highest standards of quality. Our longstanding expertise in contract manufacturing dietary supplements has uniquely positioned us as leaders in research, regulatory compliance, and quality assurance.

About the role:

We are seeking an experienced Quality Executive to lead our Quality Compliance and Quality Control functions within a dynamic lab environment. This role is pivotal in ensuring that all products meet regulatory standards, customer expectations, and internal quality benchmarks. The ideal candidate will champion a Quality by Design approach, fostering a culture of continuous improvement and operational excellence.

How will you contribute:

Quality Compliance:

• Ensure adherence to all relevant regulatory requirements (FDA, GMP, ISO, etc.) for nutraceutical manufacturing.
• Maintain and update quality systems, SOPs, and documentation to meet compliance standards.
• Oversee audits (internal, external, and customer) and manage corrective/preventive actions.

Quality Control:

• Lead and manage QC operations, including raw material, in-process, and finished product testing.
• Ensure robust analytical and microbiological testing processes are in place and validated.
• Collaborate with R&D and production teams to resolve quality issues promptly.

Strategic Leadership:

• Develop and implement a Quality by Design framework across all processes.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.
• Build and mentor a high-performing quality team.

Minimum Requirements/Qualifications:

• Bachelor’s or master’s degree in quality assurance, Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 8+ years of experience in Quality roles within nutraceutical, pharmaceutical, or food manufacturing industries.
• Previous experience in dietary supplements manufacturing, specifically with soft gel dosage forms, is highly preferred.
• Strong knowledge of regulatory requirements (FDA, GMP, ISO standards) and other regulatory frameworks relevant to nutraceutical manufacturing.
• Proven experience in managing audits and compliance programs.
• Familiarity with analytical and microbiological testing methods.
• Excellent communication, interpersonal, and organizational skills.
• Certifications preferred: ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Preventive Controls Qualified Individual (PCQI) or other relevant quality or regulatory certifications.

Work Environment:

• May involve exposure to allergens such as Soy, Wheat, Fish, Shellfish, Milk, Egg, Tree Nuts and Sesame.

More about us:

As a valued strategic partner, Best Formulations offers a comprehensive program of services, turnkey solutions, and client support that is unmatched in the industry. Our product development team can provide customized, proprietary formulations designed specifically to meet the needs of our customers and their method of distribution. Our vertically integrated manufacturing and packaging process allows us to schedule flexible production runs to respond quickly to shifting market demands. Every step of the way, we are committed to your growth and success!

"To develop and strengthen mutually beneficial relationships with our employees, customers, and business partners by providing the highest quality products and the Best customer service. Together We Grow!"

EEO Statement

Best Formulations is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Best Formulations will work with applicants to meet accommodation needs that are made known to Best Formulations in advance.

Head of Quality & Regulatory Affairs

Company: DCL Products, LLC

Location: East Haven, CT 06512

Reports to: CEO / COO

Employment Type: Full-time, On-site

Position Summary

DCL Products, LLC — along with its wholly owned subsidiaries Milbar Labs, Inc. and Dermatologic Cosmetic Laboratories — is seeking an experienced Head of Quality & Regulatory Affairs to lead all aspects of quality, compliance, and regulatory oversight at our FDA-registered, cGMP-certified contract manufacturing facility specializing in beauty, skin care, and hair care products. This leader will ensure adherence to FDA regulations, current Good Manufacturing Practices (cGMP), customer quality standards, and industry best practices while fostering a strong culture of quality throughout the organization.

Key Responsibilities

Quality Management & Compliance

Develop, implement, and maintain the Quality Management System (QMS) in alignment with FDA and cGMP requirements.

Oversee all aspects of product quality, including raw material qualification, in-process controls, finished product release, and post-market surveillance.

Lead internal and external audits; ensure timely remediation of findings and continuous improvement of compliance programs.

Monitor changes in FDA regulations and other applicable global regulatory requirements; update company policies and procedures accordingly.

Regulatory Affairs

Act as the primary liaison with FDA and other regulatory authorities, ensuring all required documentation, registrations, and facility filings are complete and up to date.

Oversee product compliance, including label reviews, claims substantiation, and regulatory submissions as applicable.

Provide regulatory guidance to R&D;, manufacturing, and client services to ensure product development and commercialization meet compliance standards.

Testing & Validation

Oversee stability testing programs, including protocol development, sample management, data review, and reporting.

Ensure appropriate testing of raw materials, intermediates, and finished products in compliance with cGMP standards.

Approve product specifications, methods validation, and analytical testing procedures.

Leadership & Cross-Functional Collaboration

Lead, mentor, and develop the Quality and Regulatory Affairs team to foster a culture of excellence and accountability.

Collaborate with Operations, R&D;, Supply Chain, and Client Services to ensure quality standards are

integrated across all functions.

Provide training and guidance to employees at all levels on FDA regulations, cGMP, and quality expectations.

Qualifications

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field (advanced degree

preferred).

10+ years of experience in Quality Assurance, Quality Control, and Regulatory Affairs, preferably within cosmetics, personal care, or pharmaceutical manufacturing.

Strong working knowledge of FDA regulations, cGMP, ISO standards, and ICH stability guidelines.

Experience leading FDA inspections and customer audits.

Proven success in building and managing high-performing quality and regulatory teams.

Excellent communication, leadership, and problem-solving skills.

Compensation & Benefits

Competitive salary

Comprehensive health and welfare benefits package

401(k) retirement plan

3 weeks paid vacation

11 paid holidays

Why Join Us

This is a high-impact leadership role at an FDA-regulated contract manufacturer with a reputation for excellence in beauty, skin, and hair care products. You’ll have the opportunity to directly shape quality systems, regulatory compliance, and company growth while working in a collaborative, entrepreneurial environment.

RTD Biosciences is building a next-generation peptide manufacturing and analytical testing laboratory, and we are looking for a Lead Analytical Chemist / Lead Laboratory Technician to help build and operate the lab from the ground up.

This is a hands-on leadership role for a scientist who enjoys working with analytical instrumentation, solving complex technical problems, and helping establish laboratory systems in a growing pharmaceutical manufacturing environment.

You will play a key role in analytical testing, method development, manufacturing support, and regulatory compliance as we expand our operations.

What You'll Do:

Analytical Testing

• Operate HPLC, LC-MS/MS, and Q-TOF systems for peptide identity, purity, and potency testing
• Perform CoA testing including assay, related substances, endotoxin, sterility, and particulate analysis
• Develop and optimize analytical methods aligned with USP and FDA expectations

Manufacturing Support

• Support peptide production including formulation, sterile filtration, and lyophilization
• Execute batch records and perform in-process testing
• Troubleshoot formulation and stability issues

Quality & Compliance

• Author and maintain SOPs, analytical methods, and quality documentation
• Support FDA inspections and regulatory readiness
• Participate in deviation investigations and CAPA

Laboratory Leadership

• Coordinate sample testing workflows
• Train and mentor laboratory technicians
• Manage lab inventory, reagents, and equipment maintenance

Qualifications:

Required

• Bachelor’s degree in Chemistry, Biochemistry, or Pharmaceutical Sciences
• 5+ years of analytical laboratory experience
• Hands-on experience with HPLC systems
• Knowledge of cGMP and USP laboratory testing

Preferred

• Experience with LC-MS/MS or mass spectrometry
• Experience with peptides, biologics, or injectable drug products
• Background in 503B outsourcing facilities or sterile compounding
• Cleanroom or aseptic processing experience

Compensation:

$90,000 – $115,000 salary + performance bonus. Some room for negotiation based on experience.

Benefits include:

• Health, Dental, Vision
• 401(k)
• PTO
• Life Insurance
• Professional development support
• Advancement pathway to Laboratory Manager

To apply, please submit your resume and a brief cover letter describing your relevant

Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There's much to learn and many to learn from, with more than 16,000 employees around the world to explore ideas and ambitions with.

Every day, your talent, your innovative spirit, and your determination will shape our future, making a positive difference on billions of people. Every essence of you enriches our world. We are Givaudan. Human by nature.

Join us as our nextRegulatory Technical Manager reporting to our Head of global Regulatory and Product Safety. You will provide business-facing regulatory support and regulatory intelligence for cosmetic ingredients (Active Beauty) across North America and Latin America, ensuring compliant, timely and pragmatic responses to customer requests and proactive anticipation of regulatory changes.

The role acts as a key interface between customers, commercial teams and internal regulatory experts, supporting market access, customer confidence and sustainable growth of the Active Beauty portfolio, under the global governance of Fragrances Regulatory Global.

Salary expectation based on technical experience: $110,000.00 $130,000.00 usd.

Location: East Hanover, NJ.

In this exciting role you will:

Business & Customer Support

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  Be a first-line regulatory partner for commercial and customer-facing teams, addressing customer regulatory inquiries related to cosmetic ingredients.

  
  
  
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  Prepare customer-facing regulatory documentation (regulatory statements, compliance letters, ingredient status summaries, market-specific assessments).

  
  
  
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  Provide clear, and risk-based regulatory guidance to support customer projects and commercialization timelines.

  
  
  
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  Support resolution of customer regulatory issues and escalations, ensuring agreement between business needs and regulatory requirements.

  
  
  

Regulatory Surveillance & Impact Assessment

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  Perform regulatory monitoring for cosmetic ingredients in NOAM and LATAM (including the US, Canada, Brazil and main LATAM markets).

  
  
  
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  Analyze new regulations, guidance documents and enforcement trends improving cosmetic ingredients; assess potential business and portfolio impacts.

  
  
  
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  Translate regulatory developments into applicable insights for internal stakeholders (commercial, R&D, marketing, and product management).

  
  
  
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  Contribute to regional and global regulatory intelligence sharing within RAPS.

  
  
  

Portfolio & Compliance Support

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  Coordinate with global RAPS, toxicology and data management teams to ensure availability, consistency and accuracy of regulatory and safety data supporting Active Beauty ingredients.

  
  
  
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  Support compliance assessments and market readiness of cosmetic ingredient portfolios for NOAM/LATAM markets.

  
  
  
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  Contribute to internal understanding on regulatory positioning and customer messaging.

  
  
  

External Relations

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  Participate in relevant industry associations, working groups and regulatory forums related to cosmetic ingredients and specialty chemicals.

  
  
  
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  Support collection of external intelligence and contribute to advocacy efforts when relevant to Active Beauty portfolios.

  
  
  

Required Qualifications:

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  University / Bachelor's Degree in a scientific field (chemistry, biology, pharmaceutical sciences or equivalent).

  
  
  
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  6+ years of regulatory experience in cosmetics, cosmetic ingredients.

  
  
  
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  Fluent English

  
  
  
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  Understanding of cosmetic ingredient regulatory frameworks and customer expectations.

  
  
  
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  Ability to translate complex regulatory requirements into clear, business-oriented guidance.

  
  
  
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  Experience with regulatory systems, databases and regulatory intelligence tools.

  
  
  

Additional Qualifications:

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  Master's degree in Cosmetic Science

  
  
  
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  Experience in customer-facing regulatory support and regulatory surveillance.

  
  
  
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  Exposure to North America and Latin America regulatory environments (FDA, Health Canada, ANVISA, Mercosur)

  
  
  

What We Can Offer You:

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  Healthcare Plan:

  
  
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    Medical

    
    
    
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    Dental

    
    
    
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    Vision

    
    
    
  
  
  
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  High matching 401k plan (For the US)

  
  
  
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  Vacation days

  
  
  

#LI-Onsite

At Givaudan, you contribute to delightful taste and scent experiences that touch people's lives.You work within an inspiring teamwork culture - where you can thrive, collaborate and learn from other talented and passionate people across disciplines, regions and divisions.

Every essence of you enriches our world. Diversity drives innovation and creates closer connections with our employees, customers and partners. Givaudan embraces diversity and is committed to building an inclusive environment where everyone impacts our world.

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• Support the setup and launch of the new Process Technologies & Development lab, including workspace organization, equipment installation support, and qualification readiness.
  
• Operate, maintain, and troubleshoot a broad range of primary container and analytical laboratory equipment, including:
  
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  • Leak detection systems
    
  • Headspace analyzers
    
  • Optical and particle counting microscopes
    
  • MicroCT scanners
    
  • Automatic filling equipment
    
  • Filtration and mixing tanks
    
  • Balances and related instrumentation
    
  
  
  
• Independently refine and develop laboratory processes and equipment workflows to improve efficiency, robustness, and usability.
  
• Maintain accurate equipment logs, calibration records, and instrument readiness documentation.
  
• Ensure laboratory organization, including consumables tracking, chemical inventory, and compliance with safety, quality, and documentation requirements.
  
• Partner with Facilities, Metrology, EH&S, and cross-functional Process Development teams to support seamless lab operations and timely issue resolution.
  

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• Apply sound scientific judgment in planning and troubleshooting experimental studies.
  
• Support method development, workflow optimization, and evaluation of new technologies relevant to primary container development and characterization.
  
• Drive continuous improvement in lab workflows, equipment utilization, and operational efficiency.
  
• Maintain a culture of cleanliness, organization, and scientific excellence within the laboratory.
  

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• Bachelor's or Master's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related technical field.
  
• Hands-on laboratory experience (academic or industry) with strong familiarity in equipment operation and laboratory best practices.
  
• Demonstrated experience designing and executing experiments with strong attention to detail and scientific rigor.
  
• Excellent organizational skills with a proven ability to maintain a clean, structured, and efficient laboratory environment.
  
• Strong communication skills and ability to manage multiple priorities in a fast-paced environment.
  

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• Experience supporting laboratory setup, including equipment installation, qualification, and initial operational readiness.
  
• Familiarity with a broad range of laboratory equipment, including routine operation, troubleshooting, and maintenance.
  
• Experience with studies involving:
  
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  • Container Closure Integrity (CCI)
    
  • Extractables and Leachables
    
  • Device-drug interface evaluations
    
  • Fill-finish operations
    
  
  
  
• Ability to design and refine lab workflows that improve efficiency and usability across teams.
  
• Prior experience working within cross-functional development teams.
  

We are seeking a hands-on QC/QA Hybrid Manager to lead our quality control operations and compliance systems in a new peptide manufacturing lab. This role combines day-to-day QC supervision, batch review, and analytical oversight with strategic quality management, including SOP development, CAPA, and regulatory readiness.

The ideal candidate thrives in a startup environment, has experience with regulated laboratory operations, and is comfortable both mentoring staff and building robust quality systems from the ground up.

Key Responsibilities

Quality Control Operations

• Supervise QC testing workflows, including HPLC, LC-MS/MS, endotoxin, sterility, and CoA generation.
• Approve or reject batches for release in collaboration with production and analytical staff.
• Manage sample scheduling, instrument calibration, and lab documentation practices.
• Troubleshoot QC and analytical issues with the Lead Analytical Chemist.

Quality Management / Compliance

• Develop, implement, and maintain SOPs, batch records, change control, and CAPA processes.
• Ensure lab operations comply with cGMP, USP, FDA, and state Board of Pharmacy regulations.
• Lead regulatory and internal audits; prepare responses for inspections.
• Ensure data integrity, documentation accuracy, and environmental monitoring compliance.

Team Leadership

• Mentor and manage QC staff and lab technicians.
• Collaborate with Lead Analytical Chemist, Production Lead, and Lab Director to coordinate lab operations.
• Foster a culture of compliance, accountability, and continuous improvement.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• 5–10+ years in regulated lab environments with hands-on QC and quality oversight.
• Proven experience with HPLC, LC-MS/MS, sterility, and endotoxin testing.
• Strong knowledge of cGMP, USP, FDA regulations, and quality systems.
• Experience writing and reviewing SOPs, batch records, and CAPAs.
• Demonstrated leadership and team management experience.
• Excellent documentation, analytical, and problem-solving skills.

Preferred Qualifications

• Experience in 503B outsourcing facilities, sterile compounding, or injectable manufacturing.
• Prior exposure to FDA, State BOP, or third-party audits.
• Knowledge of peptide chemistry, lyophilization, and stability testing.
• Ability to work in a fast-growing startup lab environment.

Compensation & Benefits

• Salary: $115,000 – $145,000, depending on experience.
• Total Comp: Up to $160,000 with performance-based bonus.
• Health, Dental, Vision, 401K, Life Insurance, PTO.
• Opportunity to grow into Lab Director or QA leadership roles as the lab expands.
• Professional development support (conferences, certifications).

Do you want to work at one of the top 100 hospitals in the nation?

Our amazing Pharmacy Team dispenses approximately 8,000,000 individualized patient doses per year, as well as 252,000 retail/mail order prescriptions. We provide medications that are safe and efficacious.

Life is full of choices, and whom you work for is one of life's most important decisions. ChristianaCare has earned national recognition for excellence. Choose an organization that provides career advancement and the opportunity to impact health.

Come and join us in the ChristianaCare Pharmacy - Dedicated to getting the right drug to the right patient at the right time!

ChristianaCare is recruiting for a Pharmacy Technician to work full time, day/evening shift rotation. Every other weekend required; holidays as required.

Principal Duties and Responsibilities:

• Assist the pharmacist in providing timely, efficient, cost effective, and appropriate pharmaceutical care to the patient
• Refill patient medication bins through robot cart fill and manual picks; update carts by including new orders, removing discontinued medications, and transferring medications. Update labeling of bins on admission, transfer, and discharge of patients
• Deliver and exchange 24-hour cart fill to nursing units at scheduled times. Check medication storage areas for discontinued and discharged patient medications; ensure that returned medications are placed back into stock
• Reorder medications in short supply and restock the picking station and other areas of the pharmacy
• Send prepared medications via pneumatic tube system. Any medication that cannot be tubed is delivered to the appropriate location on the nursing unit
• Manage automated dispensing cabinet inventory, including accurate selection and loading of medications
• Ensure that medications are stored properly and that only in date medications are stored. Remove discontinued medication
• Receive and check incoming supplier order(s)
• Prepare IV medications using aseptic techniques and in following processes in full compliance with USP 795, 797, and 800 federal regulations
• Use appropriate Personal Protective Equipment (PPE) and closed system transfer devices (as needed) for the preparation of chemotherapy and other hazardous medications

Education and Experience Requirements:

• High School Diploma required
• Pharmacy Technician Certification Board (PTCB) certification required unless enrolled in a PharmD program.
• Applicants with Pharmacy Technician experience are encouraged to apply and will be required to obtain PTCB certification within 1 year of employment.
• Applicants enrolled or graduate of a 4-year bachelor program in the following health science majors are encourage to apply and will be required PTCB certification within 1 year of employment: Applied Molecular Biology and Biotechnology Biology, Chemistry, Exercise Science, Health Behavior Science, Human Physiology, Medical Diagnostics, Medical Diagnostics Pre-PA, Medical Laboratory Science, Nutrition, Nutrition and Dietetics,  Nutrition and Medical Sciences, Nursing,  Occupational Therapy,  Physical Therapy,  Physician Assistant, Sports Health, or other health related degrees
• Hospital pharmacy experience preferred
• Computer experience preferred (e.g., window-based programs)
• Basic typing skills

Physical demands:

Standing and walking up to 8 miles a day with intermittent sitting. Occasional extended periods at computer terminal. Required movement throughout ChristianaCare. Requires manual dexterity, the ability to push or pull a fully weighted cart of 250 lbs. which is no more than 15 lbs. and lift up to 50 lbs. as essential components of the position.

ChristianaCare offers:

Incredible Work/Life benefits including medical/dental/ vision insurance coverage on your first day of employment, paid PTO, retirement plans, twelve weeks of paid parental leave, annual membership to , access to backup care services for dependents through , retirement planning services, financial coaching, fitness and wellness reimbursement, and great discounts through several vendors for hotels, rental cars, theme parks, shows, sporting events, movie tickets and much more!

If you 're inspired to make a difference, we invite you to become a ChristianaCare caregiver!

Christiana Care Health System is an equal opportunity employer, firmly committed to prohibiting discrimination, whose staff is reflective of its community, and considers qualified applicants for open positions without regard to race, color, sex, religion, national origin, sexual orientation, genetic information, gender identity or expression, age, veteran status, disability, pregnancy, citizenship status, or any other characteristic protected under applicable federal, state, or local law.

Role at a Glance

Employment Type: Full-time | Department: Quality | Reports to: Director of Quality

Experience Level: 1–3 years hands-on QC experience in a manufacturing environment ( preferably nutraceutical, food, animal health or pharmaceutical).

Work Location: Onsite – Noblesville, IN; Travel: 0-10%.

About Verdure Sciences

For nearly three decades, Verdure Sciences has been pioneering botanical ingredient excellence. From our sustainable sourcing partnerships to our branded ingredients like Longvida® Curcumin and Pomella® Pomegranate, our partners—global consumer brands—trust our commitment to botanical integrity and quality.

You will be a key member of our Quality team ensuring that every batch meets specifications, regulatory requirements, and customer standards. The focus is practical, day-to-day QC execution: coordinating testing with contract labs, reviewing data for release, and maintaining right-first-time documentation under cGMP.

We are specifically prioritizing candidates with hands-on QC experience in manufacturing environments.

Key Responsibilities

• Prepare samples and coordinate testing with qualified third‑party labs aligned to customer specifications and QC test plans.

• Review physical, chemical, and microbiological data; resolve discrepancies and confirm compliance to specifications for batch release.

• Generate Certificates of Analysis (CoA), verify labels, and execute batch release documentation with right‑first‑time accuracy and communicate with suppliers.

• Manage traceability, retains, and stability program records (sampling plans, storage, pulls, and data trending).

• Support in‑house testing routines as needed.

• Maintain document control: specifications, test methods, SOPs, and change control records.

• Participate in quality events: nonconformances, investigations, CAPA/VCAR creation, and effectiveness checks.

• Partner cross‑functionally (Supply Chain, R&D, Sales/Account teams) to resolve issues and meet customer quality expectations.

• Assist with internal/external audits (e.g., NSF, USP, Organic, Non‑GMO) and vendor/contract lab qualifications.

• Stay up to date with industry regulations and best practices related to botanical ingredients and dietary supplements.

What You’ll Bring (Required)

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Food Science or similar).

• 1-3 years of paid, hands‑on QC experience in dietary supplement, food, animal health or pharmaceutical manufacturing.

• Working knowledge of cGMP (e.g., FDA 21 CFR 111) and quality systems (deviations, CAPA, change control, data integrity).

• Experience reviewing third‑party lab reports and in‑house data; confident interpreting common analytical and microbiological methods.

• Proficiency creating CoAs and maintaining controlled documents; strong attention to detail and organization.

• Fluency with Microsoft Office and Adobe.

• Clear, professional communication skills and a collaborative approach with vendors and internal teams.

Preferred experience:

• Direct experience with dietary supplement/botanical regulations and audits (NSF, USP, Organic, Non‑GMO).

• Qualifying and managing third‑party labs; vendor performance monitoring.

• Statistics/data trending for QC (e.g., control charts, out‑of‑trend checks).

• Electronic quality/document systems and CRM systems (TrackWise, Veeva, SharePoint, Hubspot).

Work Environment & Schedule

Onsite at our Noblesville, IN office/lab | Monday–Friday, 8:30 a.m.–5:30 p.m.

Our Hiring Approach

Verdure Sciences is an Equal Opportunity Employer. We consider all qualified applicants without regard to protected characteristics and provide reasonable accommodation as required by law.

If you bring experience from botanical extracts, herbal ingredients, or plant-based nutraceuticals and have a discovery mindset for innovative quality solutions, we'd love to connect. This is your opportunity to make a meaningful impact in an industry where quality genuinely matters.

Work authorization: Applicants must be currently authorized to work in the United States on a full‑time basis.

#BotanicalIngredients #Quality #PlantBased #vsCares #Indiana #Hiring #vsLongvida #vsPomella

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

Job Title: QA Validation Specialist (Contract)

Duration: 10 months

Location: Irvine, CA (onsite)

Rate: $38–40/hr.

This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

• Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
• Authors/approves and executes qualification protocols and reports.
• Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
• Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
• Qualification of Vendors Selected.
• Input to the development of the URS/FRS/DDS.
• Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
• May present qualification studies to Regulatory and Client Auditors as required.
• Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
• Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
• Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
• Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
• Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
• Other responsibilities and special projects will be assigned based on business and customer needs.

QUALIFICATIONS:

• Bachelor’s degree in Sciences
• 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
• Strong working knowledge of cGMP and regulatory standards for validation.
• Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
• Demonstrated experience with qualification of commercial processing a packaging equipment.
• Proven track record of managing projects from start to finish on time and on budget.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

Job Overview:

Armas Pharmaceuticals is seeking a highly analytical and detail-oriented Business Data Analyst to join our growing team. This entry-level position is ideal for a recent graduate who is passionate about data analysis, business intelligence, and process improvement.

The analyst will play a key role in supporting the Finance and Operations teams by analyzing business data, preparing reporting for senior leadership, and helping improve internal data systems. The role requires strong Excel proficiency, analytical thinking, and the ability to translate raw data into actionable insights.

This position offers a unique opportunity to work cross-functionally while contributing to strategic decision-making and operational efficiency.

Key Responsibilities:

Data Analysis & Reporting

• Analyze business and sales data to identify trends, patterns, and performance insights.

• Prepare structured data sets and reports for senior management and leadership review.

• Support ongoing business reporting initiatives through data analysis and visualization.

Financial & Operational Support

• Assist the finance team with data preparation, analysis, and reporting processes.

• Support financial modeling and reporting through structured data organization.

• Ensure accuracy and consistency of financial and operational datasets.

Data Systems & Automation

• Assist in developing and improving automated reporting processes using Excel and         related tools.

• Contribute to the expansion and maintenance of the company’s internal data warehouse.

• Identify opportunities to streamline workflows through automation and improved data    structures.

Partner & Business Intelligence Support

• Prepare partner data and operational metrics to support leadership reporting.

• Work with cross-functional teams to compile and analyze key business metrics.

• Help develop scalable data processes that improve business visibility.

Innovation & Technology

• Explore opportunities to leverage AI tools and integrations to enhance business   intelligence, automation, and reporting capabilities.

• Assist in identifying technologies that improve data accessibility and decision-making.

Qualifications:

Education

• Bachelor’s degree required in one of the following or related fields:

·       Finance

·       Economics

·       Business Analytics

·       Data Science

·       Mathematics

·       Information Systems

·       Business Administration

Required Skills

• Advanced Microsoft Excel skills (pivot tables, advanced formulas, data analysis tools).

• Strong analytical and critical thinking ability.

• Ability to organize and interpret large datasets.

• Excellent attention to detail and data accuracy.

• Strong written and verbal communication skills.

• Ability to work independently while collaborating across departments.

Preferred Skills (Bonus)

• Experience with data visualization tools (Power BI, Tableau, etc.)

• Exposure to SQL or database systems

• Familiarity with data warehouse concepts

• Experience integrating or applying AI tools to business processes

Compensation & Benefits:

• Salary: $50,000 – $60,000 annually

• Performance-based bonus opportunity

• Full-time employee benefits including:

• Health insurance (after eligibility period)

• 401(k) retirement plan (after eligibility period)

• Paid Time Off (PTO)

• Participation in company incentive programs

About Armas Pharmaceuticals, Inc.

Armas Pharmaceuticals is a generic pharmaceutical company delivering an ever-growing portfolio of high-quality products that provide convenience, affordability, and consistency. Through the development of strong partnerships and industry relationships, Armas maintains this pipeline of products with customer and patient satisfaction in mind. Headquartered in Freehold, New Jersey, Armas Pharmaceuticals is always open to new partnership opportunities and ways to offer our customers the best products at affordable prices. For more information, please visit  .

Primus Pharmaceuticals is seeking a versatile Clinical Research Associate (CRA) to support the conduct of prescription medical foods clinical trials at a growing pharmaceutical company. This role offers a mix of remote monitoring, site activities, and in-office collaboration at our Scottsdale headquarters. This role is ideal for a professional who enjoys both hands-on site engagement and strategic oversight responsibilities in a fast-paced environment.

Primus is an innovative company with novel products based on unmet needs that empowers providers and patients with prescription brands that maintain the highest level of safety without compromising efficacy. We are scaling proven brands into their next chapter, and the ideal candidate will find this motivating and have the leadership and skills to drive results.

Position Overview

The CRA will collaborate closely with Primus, the vendors, and investigative sites to ensure high-quality, compliant study execution. This role requires effective communication, and the fostering of strong site relationships and operational excellence.

Roles & Responsibilities

Vendor & Site Oversight

• Provide operational oversight of monitoring activities, including the development of monitoring visit reports, follow-up letters, and issues escalation.
• Track site and vendor performance against key deliverables, KPIs, and study timelines.
• Review Trial Master File (TMF) content for accuracy and completeness.
• Contribute to study-specific documents, including monitoring, communication, and risk management plans.

In-Field & Site Monitoring

• Conduct qualification, initiation, interim monitoring, and close-out visits at investigational sites as needed.
• Verify informed consent documentation, source data, case report forms (CRFs), investigational product accountability, and protocol compliance.
• Identify and resolve protocol deviations, compliance issues, and data discrepancies directly with site personnel.
• Serve as the primary point of contact for assigned sites, building strong relationships with investigators and staff.
• Provide ongoing training and support to sites on protocol requirements, study tools, and GCP compliance.

Cross-Functional Support

• Collaborate with internal teams (Clinical Development, Regulatory, Data Management, Safety, Quality) to ensure aligned trial execution.
• Support the design, development, and refinement of essential clinical trial documents, including Case Report Forms (CRFs), monitoring plans, and study-specific instructional manuals.
• Support audit/inspection of readiness and contribute to corrective/preventive action (CAPA) planning.
• Assist in site and vendor governance meetings by providing operational feedback and insights.

Qualifications

Education & Experience

• Bachelor’s degree in life sciences, nursing, pharmacy, or related field. (Requirement may be waived for candidates with 5+ years of directly relevant professional experience) .
• 3–6 years of clinical research experience, including at least 2 years as a CRA.
• Experience in both site/vendor oversight and direct site monitoring (pharma, biotech or CRO background preferred).

Technical Skills

• EDC Proficiency: Strong technical experience using Electronic Data Capture (EDC) platforms for data entry, query management, and source data verification (SDV).
• Platform Knowledge: Familiarity with industry-standard platforms such as Medidata Rave, Veeva Vault EDC, JotForm or Medrio.
• Compliance: Deep knowledge of ICH-GCP, FDA regulations, 21 CFR Part 11, and standard clinical trial processes.

General Skills

• Demonstrated ability to manage multiple sites/trials across various therapeutic areas.
• Excellent communication, organizational, and problem-solving skills.
• Willingness to travel (approximately 10–20%).
• Comfortable working in a smaller pharmaceutical setting with the flexibility to take on broad responsibilities.

About Primus Pharmaceuticals, Inc.

Primus innovates in prescription nutritional therapies targeting metabolic causes of chronic diseases across rheumatology, dermatology, and women’s health. We develop and commercialize first-in-class products and novel deliveries in Rx drugs, medical foods, and medical devices to fill key unmet needs with universal patient access not provided by traditional pharma. Visit our website at