Pharmaceutical Sciences Jobs in Usa

3,739 positions found — Page 15

Regulatory Technical Manager
✦ New
Salary not disclosed
East Hanover, NJ 1 day ago

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




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




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




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




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





Regulatory Surveillance & Impact Assessment




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




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




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




  • Contribute to regional and global regulatory intelligence sharing within RAPS.





Portfolio & Compliance Support




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




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




  • Contribute to internal understanding on regulatory positioning and customer messaging.





External Relations




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




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





Required Qualifications:




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




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




  • Fluent English




  • Understanding of cosmetic ingredient regulatory frameworks and customer expectations.




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




  • Experience with regulatory systems, databases and regulatory intelligence tools.





Additional Qualifications:




  • Master's degree in Cosmetic Science




  • Experience in customer-facing regulatory support and regulatory surveillance.




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





What We Can Offer You:





  • Healthcare Plan:




    • Medical




    • Dental




    • Vision






  • High matching 401k plan (For the US)




  • 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.

Not Specified
Scientist - Process Development - II
Salary not disclosed
San Mateo, CA 3 days ago
Job Title: Scientist - Process Development - II

Duration: 17+ Months

Location: Foster Coty, CA94404

Client's Process Technologies & Development team is seeking a highly motivated contractor to play a foundational role in establishing and operationalizing a new Primary Container Development Laboratory. This role is ideal for a hands-on individual who enjoys building systems from the ground up and maintaining high standards of scientific rigor.

The contractor will support the setup of the new lab facility, ensure equipment is properly installed, qualified, and maintained, and develop organizational systems to keep laboratory operations running smoothly. The role also involves operating a wide range of laboratory equipment, designing and executing high-quality experiments, supporting method readiness, and maintaining scientific excellence.

This position directly supports development workflows involving container closure systems, device interface evaluations, product compatibility studies, and process characterization.

Key Responsibilities

Laboratory Operations & Equipment Expertise

  • 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:

    • 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.


Scientific Excellence & Continuous Improvement

  • 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.


Minimum Qualifications

  • 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.


Preferred Qualifications

  • 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:

    • 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.


Why Join Us?

This contract role offers the opportunity to support high-impact development programs, expand technical expertise in primary container development, and collaborate with cross-functional teams working on advanced drug product development. The role directly contributes to ensuring the delivery of safe, stable, and high-quality medicines to patients.
Not Specified
Quality Assurance Manager
✦ New
Salary not disclosed

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).
Not Specified
Commercial Analytics Manager
✦ New
Salary not disclosed
Princeton, NJ 9 hours ago

Consultant, Commercial Analytics Manager


Summary

Our mid-sized, growing pharmaceutical client is seeking a Data Analyst professional who is highly motivated and a strategic individual responsible for supporting the commercial success of our clients pharmaceutical brands. This role combines advanced analytics, data visualization, and storytelling to generate actionable insights that influence brand strategy and leadership decision-making. The ideal candidate will bring strong analytical capabilities, expertise in pharmaceutical data, and a collaborative mindset to drive performance across the organization.


Responsibilities

  • Translate complex analytics into clear, actionable insights.
  • Develop compelling, data-driven narratives to support brand strategy and executive decisions.

Power BI Development

  • Design, build, and maintain interactive, user-friendly dashboards to track brand and portfolio performance.
  • Continuously enhance visualizations based on evolving business needs.

Ad-Hoc Analytics & Creative Problem Solving

  • Conduct deep-dive analyses to support new brand launches and optimize in-line brands.
  • Apply creative thinking to uncover insights and solve complex business questions.

Portfolio Performance Management

  • Monitor and analyze KPIs across a portfolio of assets.
  • Identify trends, risks, and opportunities to inform strategic decisions.

Vendor Management

  • Coordinate with external analytics vendors to ensure timely, high-quality deliverables.

Cross-Functional Collaboration

  • Partner closely with Marketing, Sales, Market Access, Forecasting, Finance, and Market Research teams to inform brand strategy and tactical execution.

Data Integrity & Industry Awareness

  • Ensure data accuracy, consistency, and integrity across all reports and tools.
  • Stay abreast of industry trends, competitive intelligence, and evolving analytical methodologies.


Qualifications/Experience:

  • 3+ years of experience in pharmaceutical data science, brand analytics, or commercial analytics, with at least 2 years in the pharmaceutical or life sciences industry.
  • Experience with specialty pharmacy data and related analytics.
  • Strong command of pharma data sources (e.g., IQVIA, Symphony, Komodo, claims data, specialty pharmacy, field activity data).
  • Proficiency in data visualization & analytics tools (Power BI, Tableau, Excel, SQL, Python, or SAS).
  • Preferred: Experience in nephrology, rare disease, oncology, or specialty pharmacy distribution.
  • Education: Bachelor’s degree in Business, Statistics, Economics, Life Sciences, Computer Science, or a related field.


Term & Start

  • 12 month contract – possible option to extend.
  • Start 2-3 weeks from an offer.
  • Remote with ability to go onsite 1 X per week in Princeton, NJ
  • Benefits available (Medical, Dental, Vision, 401k
Not Specified
Pharma Segment Lead
✦ New
Salary not disclosed
New york city, NY 9 hours ago
Pharma Segment Lead

IQVIA is a leading global provider of research and development, commercial solutions, and technology-enabled services to the life sciences industry. We help customers accelerate innovation and improve patient outcomes by combining deep scientific expertise with advanced data assets, transformative technology, and integrated services. IQVIA Digital builds on this foundation to deliver omnichannel engagement strategies powered by privacy-optimized data, advanced analytics, and scalable technology, enabling pharmaceutical companies to connect with healthcare professionals and patients in meaningful, measurable ways.

Role Summary

The Pharma Segment Lead defines and drives IQVIA Digital's segment-level strategy for pharmaceutical clients. This role sets the vision for how we position our capabilities and value proposition, ensuring alignment with client needs and market trends. The Pharma Segment Lead combines strategic thinking with hands-on storytelling, creating compelling narratives and resources that enable sales, marketing, and product teams to win and grow business. The role is accountable for measurable commercial outcomes and plays a critical part in IQVIA Digital's continued growth trajectory.

Key Responsibilities

Segment Strategy:

  • Develop and own the segment strategy for IQVIA Digital offerings across large pharma and other prioritized segments, including key accounts and EBP (pre-commercial, small, and mid-sized pharma).
  • Identify growth opportunities, prioritize products and solutions, and influence product development roadmaps to address gaps.
  • Participate in strategic forums such as product summits to pressure-test ideas and ensure alignment with market needs.
  • Monitor market trends, competitive dynamics, and customer needs to inform strategy and scenario planning.

Strategic Storytelling:

  • Craft and adapt executive-ready narratives that articulate IQVIA Digital's vision, capabilities, and proof points, tailored by segment and therapeutic area (oncology, rare disease, immunology, cardiometabolic).
  • Build clear, concise, and compelling presentations for client innovation days and senior-level engagements.

Collaboration & Client Engagement:

  • Lead planning for client innovation days and strategic meetings, partnering with Sales and Product to define objectives, storyboards, and partnership opportunities.
  • Serve as a commercial strategy SME in high-level pharma client meetings and innovation days.
  • Support Sales in key strategic meetings by co-leading preparation and delivery of material.
  • Collaborate with Marketing and Thought Leadership teams to shape and amplify IQVIA Digital's points of view, ensuring consistency across external engagements.

Commercial Enablement:

  • Package offerings for lead generation and sales enablement, ensuring resources are current and aligned with GTM priorities.
  • Contribute to strategic account reviews and cross-functional initiatives to integrate IQVIA Digital solutions into broader offerings.

Partner Strategy & Innovation:

  • Contribute to GTM partner strategy including leading evaluation, recommendation, and implementation of partners.
  • Identify emerging technologies or partnerships that could enhance IQVIA Digital's value proposition.

Customer Experience & Data-Driven Insights:

  • Champion a customer-centric approach to solution design and engagement.
  • Leverage data and analytics to inform strategy and track performance.
Qualifications

- 10+ years in pharmaceutical brand and/or marketing roles; agency experience strongly preferred.

- Management consulting experience in life sciences or healthcare strategy is highly desirable.

- Recognized industry presence through publications, speaking engagements, or thought leadership contributions.

- Proven ability to develop and deliver strategic narratives and executive-ready presentations.

- Deep understanding of pharma customer needs across functions and market trends shaping future requirements.

- Experience across major therapeutic areas (oncology, rare disease, immunology, cardiometabolic).

- Exceptional skills in strategic thinking, storytelling, slide design, and cross-functional collaboration.

Travel

Approximately 5% (one trip per quarter for client meetings or industry events).

To be eligible for this position, you must reside in the same country where the job is located.

IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law.

The potential base pay range for this role, when annualized, is $121,400.00 - $338,400.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

Not Specified
Quality Control Associate
Salary not disclosed
Noblesville, IN 3 days ago

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

Not Specified
QA Validation Specialist (Contract)
Salary not disclosed
Irvine, CA 3 days ago

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.

contract
Clinical Research Associate
✦ New
Salary not disclosed
Scottsdale, AZ 1 day ago

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

Not Specified
Document Control & Training Manager
🏢 Kelly Science, Engineering, Technology & Telecom
Salary not disclosed
Sacramento, CA 2 days ago

Kelly® Science & Clinical is seeking a Document Control & Training Manager for a Direct Hire position at a leading specialty pharmaceutical company in Sacramento, 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 Hiring Experts.


Salary:

$80-90k


Overview:

In this role, you will lead and mentor teams to manage document control and GMP training programs, ensuring regulatory compliance and inspection readiness, driving digital transformation, supporting cross-functional collaboration, and fostering a culture of continuous improvement and operational excellence within a fast-growing pharmaceutical and biotech organization.


Schedule:

Monday-Friday, standard working hours



Responsibilities:

  • Lead and Develop Teams: Direct, mentor, and inspire the Document Control and GMP Training teams, fostering growth, accountability, and continuous improvement.
  • Set Strategic Direction: Establish KPIs, objectives, and overall strategy for document control and training in alignment with organizational quality goals.
  • Champion Regulatory Compliance: Ensure robust document management and training programs meet global regulatory requirements (21 CFR 210/211, EU GMP) and maintain inspection readiness.
  • Oversee Document Lifecycle: Supervise the creation, organization, revision, archival, and retrieval of critical documents such as SOPs, Master Batch Records, and logbooks for multi-product/multi-site operations.
  • Manage GMP Training Programs: Oversee employee training curricula, ensuring all staff are qualified, compliant, and prepared for evolving processes or regulatory changes.
  • Drive Process Improvement: Proactively identify workflow bottlenecks, elevate document control best practices, and implement scalable solutions across the organization.
  • Lead Digital Transformation: Act as the Business System Owner for electronic document and training management systems, overseeing system configuration, validation, and integrity per regulatory standards (21 CFR Part 11).
  • Support Audits and Inspections: Represent quality systems during FDA/EMA audits, regulatory inspections, and customer visits, and deliver improvement strategies to leadership.
  • Collaborate Cross-Functionally: Work closely with QA, Manufacturing, Regulatory, IT, and Engineering teams to drive seamless quality operations and support remediation efforts as needed.
  • Uphold Culture and Standards: Set clear policies and productivity benchmarks, promote ethical practices, and cultivate a strong culture of operational excellence and compliance company wide.


Qualifications:

  • Bachelor’s degree in Science, Engineering, or related field, Master’s degree strongly preferred.
  • 8+ years of QA experience in a GMP-regulated environment.
  • 3+ years of people management experience.
  • Extensive knowledge of cGMP (21 CFR 210/211), EU GMP, GDP, 21 CFR Part 11, and ALCOA data integrity principles.
  • Demonstrated expertise as a Business System Owner for digital Document Control/Training systems.
  • Proven experience supporting successful regulatory inspections and customer audits.
  • Superior project management, change leadership, and communication skills.
internship
Senior Scientist
✦ New
🏢 Kelly Science, Engineering, Technology & Telecom
Salary not disclosed
Spring House, PA 3 hours ago

Senior Scientist

Kelly Science and Clinical, is currently seeking a Senior Scientist (Protein Mass Spectrometry) for a long-term engagement at one of our Global pharma clients in Spring House, PA. This role is a fully benefitted position. This role you will be eligible for Medical, Dental, 401K, paid time off, including holiday, vacation and sick/personal time.

Schedule: On-site Monday through Friday 8am to 5pm

Length of assignment: Until the end of 2026 will likely to extend

Pay: $45-50 an hour Depending on experience

You will be required to provide your own laptop


  • Responsibilities:Intact protein mass analysis using LC/MS platforms- QC analysis and high throughput analysis for biologics (mAbs, multispecifics antibodies, Fabs, scFv, fusion proteins)
  • Data analysis, documentation, and reporting – ELNs, etc.
  • Lab instrument maintenance – General ESI source cleaning and routine calibration
  • Prepare HPLC solvents and replenish as needed
  • Prepare general buffers and reagents for enzymatic digestions and assays etc
  • MS Lab-specific supply maintenance – inventory and ordering
  • Chemical inventory for EHS
  • Additional Duties:
  • Support assay development and validation as needed.
  • Assist in drafting and executing peer-reviewed posters, manuscripts, tech reports, and patent filings.
  • Attend in-house seminars to support team goals.
  • Requirements: Experience with mass spectrometry is required.
  • Previous experience handling and working with proteins using general protein biochemistry techniques including but not limited to aliquoting and pipetting is required.
  • Pharmaceutical experience working with antibodies is preferred.
  • Experience with automated liquid handlers is preferred. Pharmaceutical experience working with antibodies is preferred.
  • Candidate must be highly organized, independent, and very detail oriented.
  • Education requirements: Ph.D. with 0-2 years’ experience, or MS with 3-5 years’ experience, or a B.S. with 10+ years in an analytical chemistry discipline


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 all of our recruiters will have access to your profile, expanding your opportunities even more.

Helping you discover what’s next in your career is what we’re all about,

#P1

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