Analytical and Microbiology Quality Manager

Role Summary

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.

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.

Qualifications

• Required: Bachelor’s Degree in a life-sciences or engineering discipline with 10+ years of progressive experience in a GMP regulated cell therapy environment.
• Required: 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.
• Preferred: Leadership experience successfully managing personnel and projects.
• Preferred: Experience in clinical manufacturing.
• Preferred: Experience with contract manufacturing organizations.

Skills

• 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.
• Ability to work with a high degree of autonomy.

Education

• Required: Bachelor's Degree in a life-sciences or engineering discipline with 10+ years of progressive experience in a GMP regulated cell therapy environment.
• Required: Advanced degree in a life-sciences or engineering discipline with 8+ years of progressive experience in a GMP regulated cell therapy environment.

Additional Requirements

• This position works on-site in Torrey Pines, CA.
• Periodic travel may be required to support audits or external laboratory oversight.
• Flexibility in working hours, i.e., off hours, second shift, weekend and travel work as required.
• May require extended hours during inspections, investigations, or critical release activities.
• Ability to gown and gain entry to GMP areas as needed.