Analytical and Microbiology Quality Manager
About The Position
The Analytical and Microbiology Quality Assurance (AMQA) organization provides phase-appropriate, global quality assurance to the Quality Control group (QC). As microbiology and analytical QA Subject Matter Experts (SMEs), AMQA collaborates with the QC team in all aspects related to the development, verification, qualification, validation, transfer and optimization of analytical and microbiology test methods used for internal and external product testing. AMQA supports qualification and release of reference standards, internal and external stability testing, supports regulatory filings including INDs and BLAs, and reviews/approves all QC GMP records including SOPs, Certificates of Analysis, deviations, change controls, CAPAs, internal findings and laboratory investigations. The Analytical and Microbiology Quality Manager provides quality oversight and approval of GMP laboratory operations supporting microbiological and analytical testing performed both in-house and at external contract testing organizations (CMOs/CTOs). This role ensures that laboratory activities supporting development characterization and product release are conducted in accordance with applicable quality standards and that data generated are reliable, accurate, and suitable for regulatory and commercial decision-making. The position will serve as a quality partner to QC, Product Development, Process Sciences and external testing laboratories, while maintaining independent QA authority.
Requirements
- Bachelor’s Degree in a life-sciences or engineering discipline with 10+ years of progressive experience in a GMP regulated cell therapy environment required; or Advanced degree in a life-sciences or engineering discipline with 8+ years of progressive experience in a GMP regulated cell therapy environment required
- Experience with the following QC assays: cell-based assays, HPLC (RP, SEC, IEX), ELISA, SDS-PAGE (reduced and non-reduced), HCP, mycoplasma, sterility, endotoxin, and bioburden required
- Experience working under 21 CFR 210/211, ICH guidance applicable to cell therapy and pharmaceutical products, and the United States and European Pharmacopeias required
- Experience in Process Validation required
- Experience in a commercial phase cell therapy environment required
- Experience in a leadership role successfully managing personnel and projects desirable
- Proficiency with the following QC assays: cell-based assays, HPLC (RP, SEC, IEX), ELISA, SDS-PAGE (reduced and non-reduced), HCP, mycoplasma, sterility, endotoxin, and bioburden.
- Strong understanding of GMP requirements for microbiology and analytical QC.
- Ability to work both independently without supervision and be a part of a team, demonstrating excellent communication and interpersonal skills.
- Ability to effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines.
- Strong problem solving and analytical skills with demonstrated ability to be detail oriented, while managing multiple projects simultaneously.
- Ability to influence without authority
Nice To Haves
- Experience in clinical manufacturing is desirable
- Experience with contract manufacturing organizations is preferred
Responsibilities
- Provide QA oversight of microbiology and analytical assays performed at in-house and external GMP QC laboratories.
- Review and approve laboratory data and documentation related to microbiological testing, environmental monitoring, and analytical assays.
- Review and approve environmental monitoring results, trends, and excursions for laboratory and biosafety cabinet environments.
- Provide QA oversight for analytical testing supporting product development, characterization, and product release including internal and external laboratories.
- Review and approve analytical data, reports, and summaries used for: Lot release Stability Assay and product development Product comparability or lifecycle activities
- Review and approve investigations, deviations, and CAPAs related to analytical testing, data integrity, contamination events, EM excursions, and assay failures.
- Ensure appropriate quality oversight mechanisms are in place for external testing partners.
- Provide on-site QA support for regulatory inspections and partner audits.
- Furnish quality oversight of the Stability and Reference Standard program.
- Ensure data integrity principles are applied consistently across microbiology, and analytical testing activities.
- Evaluate the suitability of laboratory data for use in regulatory submissions and batch disposition decisions.
- Support preparation and approval of responses to observations related to microbiology and analytical testing.
- Provide subject matter expertise for laboratory compliance during inspections.
- Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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What This Job Offers
Job Type
Full-time
Career Level
Manager
