Pai Pharma Jobs in Usa

• Join a fast-growing specialty pharma company focused on neurology and CNS therapies
• Be part of a major expansion following a successful new drug launch
• Comprehensive benefits: health, dental, vision, 401(k), life, disability, PTO
• Collaborate directly with leadership to shape future product launches
  
  

• Manage and grow an assigned neurology/epilepsy sales territory
• Develop and maintain strong relationships with physicians, hospitals, and key accounts
• Promote the company’s flagship epilepsy product using clinical and market insight
• Execute strategic sales plans and exceed quarterly revenue goals
• Collaborate with marketing, managed care, and internal teams to drive territory success
  
  

• Bachelor’s degree with proven success in pharmaceutical or biotech sales
• Launch experience in CNS or neurology preferred
• Strong communicator with exceptional relationship-building and negotiation skills
• Self-motivated, competitive, and results-driven
  
  

Who we are: Ketchum & Walton is a trusted manufacturers’ representative serving industry leaders in Noise Control, HVAC Equipment, and Indoor Air Quality. We help clients achieve greater efficiency and cost savings through innovative solutions in air filtration, architectural and interior noise control, HVAC systems, and vibration isolation.

We’re proud to partner with top-tier manufacturers who are committed to continuous improvement, cutting-edge research, and advancing technology. Our work environment reflects these values—creative, collaborative, and focused on solving complex problems for our clients.

At Ketchum & Walton, our core values are the foundation of everything we do. We’re a team that thinks strategically, works collectively, and strives to be a world-class organization. If you’re driven, innovative, and ready to make an impact, we’d love to hear from you.

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What we need: The Sales Consultant (Architectural Acoustics) is results-driven and strategically aligned, requiring a proactive, competitive, and entrepreneurial-focused individual. It demands quick decision-making, innovation, and the ability to lead with confidence and urgency through change. Our ideal candidate is a self-motivated, goal-oriented leader who communicates effectively, adapts quickly, and thrives in a fast-paced environment. Enthusiasm, accountability, and high performance are key, with an emphasis on successful behaviors and process.

Key Responsibilities

·         Documented Sales Plan (Sandler – Cookbook): Includes defining market segments such as Healthcare, Pharma, Industrial, Education, Government, Commercial, and Mission Critical. It covers territory management, organizing social events like trade shows, trade associations, lunch & learns, and personal entertainment. Sales activities including appointments, prospecting, site surveys, and entertainment are tracked diligently. The plan also requires accurate forecasting and budgeting of annual sales volume, margins, and product mix.

·        Industry Knowledge: Involves understanding appropriate product applications for each market segment (e.g., Healthcare), familiarity with online search tools and media resources like trade journals and business periodicals, and awareness of competitors' products, pricing, lead times, and services. Additionally, it requires the ability to read and interpret architectural/mechanical drawings and commitment to continued personal development within the specialty area.

·        Customer Knowledge: Entails recognizing behavioral characteristics and culture of clients (using tools like PI, or DISC), identifying and understanding the roles and influence of specifiers, influencers, and decision-makers, as well as understanding key performance drivers and success criteria by identifying and eliminating pain points. It also includes recognizing personal vulnerabilities within customer relationships and promptly mitigating risks, plus qualifying customers to ensure alignment with business goals.

·        Relationship Skills: Focuses on building and maintaining long-term relationships, networking effectively with clients and industry professionals to achieve business goals and ROI, contributing productively in team environments, and continuously self-reflecting through customer feedback to improve service quality.

·        Selling Skills: Centers on following a proven sales process (such as Sandler Sales Mastery) to improve results and shorten sales cycles. Key skills include prospecting and developing new business, setting meetings with clear upfront contracts, building rapport, employing strategic questioning to uncover customer needs, active listening and observation of verbal and non-verbal cues, presenting solutions that address those needs, using innovative sales tools (like manufacturer analytics, LCC, and multimedia presentations), matching solutions and pricing to ensure win-win outcomes, providing well-written, detailed proposals, handling objections effectively, negotiating for positive results without selling on price alone, and securing customer commitment to proceed.

·        Product Knowledge: Requires deep understanding of product features and benefits, proficient use of manufacturers’ sales tools, technical expertise to ensure correct application, ability to generate project- or customer-specific specifications, comprehensive knowledge of the filter, architectural industry and engineering principles, and capability to provide field guidance for installation and troubleshooting.

·        Quoting: Involves receiving customer bid lists and organizing bids in a calendar, reviewing bid drawings and specifications to identify opportunities for represented products, coordinating with factories to obtain scopes and quotes, compiling proposals for bidding contractors, and following up with customers to assess potential low bidders and arrange scope reviews.

·        Project Management: Includes verifying purchase orders against quotes, entering sales orders, setting up electronic job files, issuing material purchase orders, providing order status updates and expediting as needed, and managing project submittals documentation and closeout.

·        Travel: 15-20%

·        Other duties as assigned

What you need: Minimum Qualifications

• High school diploma or equivalent required.
• Additional education or certifications in relevant fields are a plus.
• Proven ability to develop and execute sales plans across diverse market segments.
• Strong knowledge/willingness to learn industry products and applications, including technical drawing interpretation.
• A baseline understanding of acoustics (noise control, interior acoustics) is a plus.
• Excellent relationship-building skills with a deep understanding of customer needs and decision-making processes.
• Proficient in a structured sales process (e.g., Sandler), with strong prospecting, qualifying, and closing abilities.
• Skilled negotiator with the ability to handle objections and secure customer commitments.
• Effective communicator, both written and verbal, with strong networking and teamwork capabilities. The ability to work and succeed as a team is paramount.
• Analytical mindset with experience managing bids, pricing, and competitive analysis.
• Detail-oriented and organized in managing orders, documentation, and project turnover.
• Proficient in software including but not limited to: Microsoft Office Suite (Word, Excel, Outlook, Teams), Bluebeam, Adobe

Reports to: Director of Sales

Status: Full-Time, onsite

Job Class: Exempt

We are proud to be 100% employee-owned (ESOP) and committed to investing in our people. Our team members enjoy an extensive benefits package, including:

• Annual contribution into ESOP account
• 100% employer-paid healthcare premiums
• Biannual bonus opportunities
• Paid time off, holidays, and leaves
• 401(k) retirement plan
• And more!

Ketchum & Walton is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business need—regardless of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other protected status under applicable law.

Please note: We are not engaging with recruiting agencies for this position and will not respond to agency inquiries

The Sr. Project Engineer will support manufacturing operations with the introduction of new processing, packaging or facility fixed capital assets. Identify, develop and implement process improvements. They will also serve as a technical resource for designing and implementing technical solutions. Accountable for timely delivery of project engineering deliverables in a multi-functional environment. This could involve the relocation and optimization of the existing fixed asset base and/or the purchase of new fixed assets.

Essential Duties and Key Responsibilities:

• Managing capital projects from initiation to delivery utilizing engineering project management processes and procedures
• Adhering to regulations, industry best practices, and company engineering standards.
• Ensuring the successful completion of all project phases; Initiating, Planning, Executing, Controlling, & Closing.
• Develop and manage Resource Plans throughout the project lifetime.
• Develop and manage Communication Plans with all stakeholders throughout the lifetime of the project.
• Develop and manage Budget & Cost plans throughout the project lifetime.
• Providing technical solutions, design support, and equipment troubleshooting assistance to operations.
• Recommending and implementing continuous improvement projects and developing the necessary justifications and return on investment to drive these improvements.
• Developing knowledge mastery in new systems to train and coach plant engineers and maintenance staff with thorough transfer of knowledge and documentations.
• Ability to multi-task and work in a fast-paced and dynamic manner with quick response to change of direction.
• Proposing and implementing work processes, procedures and technical resources in accordance with the Engineering Policy.

Qualifications:

• BS Degree in Mechanical, Chemical, or Electrical.
• Minimum 8 - 10 years Project Engineering or Management Experience in a fast-paced manufacturing setting with experience in Food & Beverage, or Pharma manufacturing.
• Strong experience in capital project management utilizing standards and projects delivery through Initiation, planning, and execution.
• Skilled in developing DQ, FAT, CQV, Ramp up analysis, and other project management protocols.
• PE or SrPE, plus PMP certification preferred.
• Proficient in MS Office especially Excel and Microsoft Project, and ability to use CAD to develop and edit system designs and machine layouts. Ability to read electrical schematics, P&ID, construction drawings, and other technical documents.
• Demonstrated successful experience in a beverage, aseptic and/or food manufacturing environment.
• Understanding of financial analysis, relevant business KPI's and CAPEX budgeting preparation and tracking within approved budgets.

The Director Quality Affairs is in charge of providing subject matter expertise on matters related to FDA regulatory compliance requirements, as well as leading the growth and responsibilities of the Quality Department. Responsible for maintaining the company’s Quality Management System’s (QMS). The Director represents the company in key stakeholder and strategy meetings on all quality matters related the company’s assets (development and manufacturing), including meetings with executive leadership, meetings with FDA and other regulators, and working with development and manufacturing partners. This role combines scientific, regulatory, and business knowledge to assure that products are developed within GXP compliance while meeting the company’s strategic goals.

Essential Duties and Responsibilities:

Quality

• Manages GXP quality activities.
• Builds on the company’s Quality Management System; formulates the company’s GMP, GLP and GCP compliance strategies and provides advice and support for clinical development programs.
• Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, storage and distribution sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
• Oversee the QA reviews of GMP manufacturing and packaging batch records, product release and stability testing, validation reports, and essential clinical study documents.
• Assess all GMP compliance risks and develop and implement risk mitigation measures.
• Develops and implements standards, policies and procedures for GMP, GLP and GCP compliance.
• Partners with CMC, Clinical Development and Clinical Operations to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance.
• Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, storage and distribution, CROs and other service providers used to support the clinical development programs.

Operations

• As the company grows, build a strong quality team to meet the needs of the business.
• Manage quality vendors.
• Develop and mentor quality staff/personnel.

Supervisory Responsibilities:

• Yes, in the future

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

• Over 10 years of progressive advancement within GMP, GLP and GCP in the pharmaceutical /biotech industry.
• A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines.
• Ability to speak and interact with a diverse group of individuals on technical and business topics.
• Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena.
• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.
• Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively, both internally and externally.
• Proven ability to lead and manage complex global projects to successful completion.
• Flexibility/agility to respond to Renew’s evolving business needs.
• Strong ability to influence and gain credibility with both internal and external key stakeholders.
• Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex Quality issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
• Ability to build collaborative relationships both internally and externally.
• Ability to inspire, motivate and develop regulatory and quality teams.
• Ability to prioritize and handle multiple projects simultaneously.
• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with scientists, managers, peers, and staff.

Education and/or Experience:

• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree preferred.
• 10 +yrs. of industry experience (biotech/pharma/ CRO) with at least 8 years of QA experience
• Experience in ANDA and NDA FDA inspections (sponsor, vendor and sites)
• Strong understanding of ICH, GMP, GCP and relevant regulatory requirements
• Strong operations and management skills with attention to detail
• Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project

Equal opportunity employer

Sr. Quality Control & Sample Management Specialist

Our client is looking for an experienced QC and sample management professional to support high‑quality data generation within our Translational DMPK and Clinical Pharmacology team. This role ensures accuracy, compliance, and smooth sample lifecycle management across internal and external studies.

Responsibilities

• QC review of bioanalytical data (LC‑MS/MS, ELISA, qPCR) and study documentation from internal teams and CROs
• Manage and review scientific documents in SharePoint
• Format internal reports and provide templates to CROs
• QC review of packing slips, manifests, and critical reagent documentation
• Contribute to drafting and editing bioanalytical lab guidelines
• Routine QC of Electronic Lab Notebooks
• Audit finalized reports and maintain errata
• Use LIMS (LabVantage) for sample receipt, tracking, aliquoting, storage, shipping, and disposal

Requirements

• Bachelor’s degree in a scientific or healthcare field
• 5+ years QC experience in pharma, biotech, or CRO environments
• Proficiency with LIMS (LabVantage preferred) and electronic notebooks
• Strong understanding of GxP regulations
• Excellent attention to detail, communication, and organizational skills
• Proficiency in Microsoft Word, Excel, and PowerPoint
• Familiarity with bioanalytical assays is a plus

Outside Sales Representative – Regenerative Medicine (Wasatch Front)

Cellcura Sciences

Utah (Wasatch Front focus · in-state only)

 Commission role with $6,000/month base (up to 6 months) + uncapped upside

About Cellcura Sciences

Cellcura Sciences is a Utah-based life sciences company advancing regenerative medicine.

Our flagship product:

• Terminally irradiated, filtered amniotic fluid
• One-year shelf life
• Stored at 2–30°C (simple logistics)

We’re building a lean, execution-focused commercial team and are looking for an outside sales rep who wants to be in the field, build real relationships, and grow with an early-stage company.

The Role

This is a hands-on outside sales role focused on execution

You’ll carry out a defined sales strategy by calling on med spas, clinics, physicians, and regenerative medicine practices across the Wasatch Front. This role is ideal for someone who is energetic, coachable, interested in health and wellness, and motivated by performance-based compensation.

You don’t need to be a subject-matter expert on day one. We’ll train you. You do need to be curious and comfortable learning basic biology and regenerative medicine concepts.

This role can be structured as W-2 or 1099, depending on experience and fit.

What You’ll Do

• Execute a defined sales strategy across the Wasatch Front
• Prospect, schedule, and conduct in-person sales calls with:
• Med Spas
• Clinics
• Physicians
• Surgical and regenerative medicine practices
• Build trust-based relationships with physicians, practice managers, and clinical staff
• Clearly communicate product benefits and differentiation
• Learn and confidently present foundational concepts related to:
• Amniotic fluid
• Regenerative biology
• Support product evaluations, onboarding, and early adoption
• Maintain CRM activity and share field feedback with leadership
• Represent Cellcura Sciences professionally in all clinical settings

Who We’re Looking For

• 1–5 years of outside sales experience
• (medical, device, biologics, pharma, or adjacent B2B preferred)
• Strong interest in health, wellness, and regenerative medicine
• Basic understanding of biology, anatomy, or cell science
• (formal education or self-taught)
• Coachable and comfortable learning scientific concepts
• High energy, self-motivated, and disciplined with territory management
• Professional appearance and demeanor appropriate for physician-facing roles
• Strong communication and relationship-building skills
• Valid driver’s license and ability to travel locally within the Wasatch Front

Compensation & Structure

• Commission-based compensation with uncapped upside
• $4,000/month draw for up to 6 months during ramp up
• Continued employment expected to exceed draw through commissions by month six
• W-2 or 1099 structure depending on experience and fit
• No out-of-state travel required

Why Join Cellcura Sciences?

• Differentiated regenerative product with strong market demand
• Room temperature storage for simple logistics compared to many biologics
• Direct access to founders and leadership
• Opportunity to grow as the commercial team expands
• Performance-based upside without corporate bureaucracy

How to Apply

Submit your resume along with a brief note covering:

• Relevant sales experience
• Interest in regenerative medicine or health sciences
• Any biology, science, or medical background (formal or informal)

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

MES (PAS-X) Lead Engineer (Biotech/Pharmaceutical)

Location – Wilson, NC

Aztec Technologies is an engineering and consulting firm providing expertise in the

pharmaceutical and biotechnology industries. Aztec Technologies and Aztec Process Automation

are part of Trinity Consultants Company.

Trinity Consultants, Inc., a leading international EHS, life sciences and environment consulting

services with 1500+ engineers worldwide.

Aztec Technologies provides solutions for Manufacturing Applications:

• Process and Facility Automation

• Project Management

• MES

• Data Analytics

With offices across 3 continents, consulting firm with over 20 years of experience within the

biopharmaceutical and pharmaceuticals industries.

The successful candidate will work with a group of engineers involved in the design, automation,

commissioning and start-up of various processes, systems, and facilities. A combination of

strong technical aptitude, automation engineering skills and technical writing are the desired skill

set. This is an outstanding opportunity to join our growing team and to work in the Life Sciences

space that will enhance professional opportunities!

Candidates need to be local or willing to relocate to the areas of operation where we have open

opportunities for immediate hire in the Wilson, NC area:

Key Responsibilities:

• Own MES configuration management for PAS-X, including:
• Manufacturing Batch Records (MBRs)
• Material management
• Equipment and timer management
• Label management
• Lead MES design, configuration, testing, and troubleshooting
• Act as technical interface between MES, DCS (DeltaV), ERP, LIMS, and other shop-floor systems
• Support MBR migration from a legacy site
• Ensure alignment with site and global MES standards
• Support risk assessments and GMP compliance activities
• Provide hands-on troubleshooting and technical support during execution
• Develop and maintain MES technical documentation
• Collaborate closely with IT, Manufacturing, Quality, and Engineering teams

Required Qualifications

• 8+ years experience in pharmaceutical or biopharmaceutical manufacturing environments
• Strong hands-on experience with MES platforms, preferably Werum PAS-X
• Proven experience with MBR design and execution
• Solid understanding of GMP manufacturing processes
• Experience integrating MES with DCS (DeltaV) and enterprise systems
• Strong analytical, troubleshooting, and problem-solving skills
• Bachelor’s degree in Engineering, IT, Science, or related discipline

Preferred / Nice-to-Have Skills

• Programming experience: .NET, SQL / PL-SQL, Java
• Experience with OPC servers/clients
• Knowledge of 21 CFR Part 11 and EU GMP Annex 11
• Process knowledge across:
• Upstream
• Downstream
• Bioprocess support functions
• Ability to communicate effectively with both technical and non-technical stakeholders

Ideal Candidate Profile:

• Senior-level PAS-X MES SME
• Strong on-site presence and ownership mindset
• Comfortable operating as Owner’s Rep, not a junior configurator
• Deep pharma/biotech automation background
• Able to bridge Manufacturing, IT, Automation, and Quality

• Shape enterprise-wide QA/QC/QE strategy in a high-visibility leadership role
• Lead inspection readiness and partner directly with FDA/EMA
• Build and scale a high-performing Quality organization
• Influence antibody development, biologics manufacturing, and tech transfer
• Competitive salary, strong benefits, and onsite leadership visibility
  
  

• Driving Quality strategy, systems, and culture
• Leading QA/QC/QE teams and quality operations
• Managing audits, compliance, and regulatory interactions
• Overseeing QMS, CAPA, deviations, document control
• Supporting CMC, manufacturing, and client-facing quality needs
  
  

• 15+ years QA in pharma/biopharma; 5+ years leadership
• Extensive GxP and global regulatory expertise
• CDMO or biologics background preferred
• Strong communicator and cross-functional partner
  
  

WHO WE ARE

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Manager, Quality Assurance Plant Operations, is responsible for leading QA plant operations and expertise in manufacturing plant operations. This includes developing QA specific procedures related to product disposition, line clearance and review and approval of GMP documentation including but not limited to Batch Records, Validation Protocols/Reports, and Calibration/Work Order Records. The ideal candidate has worked in a startup environment with internal manufacturing operations. The candidate will also assist, as required, with product receipt, shipment and disposition, line clearance and quality system review/ approval in the QA role. This is a full time, on-site role at our Hopkinton, MA location. Weekends and holidays may be required.

How You Will Make an Impact:

• Lead the day to day operations for the Quality Assurance team. This includes but is not limited to oversight of product disposition, deviation, CAPA, Change Control, internal audit and training.
• Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement
• Work cross functionally and provide QA support for development, review and approval of procedures/workflows for manufacturing operations
• Provide QA review and approval of plant related SOPs and GMP documentation
• Support product disposition and shipping
• Support Health Authority Inspections and Client Audits
• Mentor personnel within QA and cross functionally on GMP compliance, promote quality culture
• Other duties as assigned.

What You Will Bring:

• A highly organized work style that ensures timely execution of tasks.
• A mindset that ensures accurate results.
• Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
• Effective problem-solving capabilities.
• Strong oral and written communication skills.

Qualifications:

• 8+ years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing. Cell therapy experience preferred.
• Minimal 2 years leadership experience as a supervisor/leader or manager.
• Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations.
• Prior experience working in contract services and interfacing with clients preferred
• Ability to partner cross functionally and be quality lead within agreed timelines to support plant start up activities
• Ability to resolve issues and make decisions independently and escalate complex decisions as needed.
• Act as QA lead for tech transfer, client projects and GMP related activities.
• Partner cross functionally and provide quality support within agreed timelines to support plant start up activities.
• Well versed in cGMP and ICH regulations / guidelines
• Strong verbal and written communication skills

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal-opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.