Overview
The Principal, Quality Control is responsible for providing subject matter expertise (SME) in analytical method qualification, validation, and regulatory submission authoring for cell therapy products. This role partners closely with Analytical Development, Manufacturing, MSAT, Process Development, Regulatory, and Quality Assurance to support technology transfer, method validation, and commercialization efforts including preparation for Biologics License Application (BLA) submission(s).
The incumbent will serve as a Quality Control representative on cross-functional project teams, ensuring that product-related activities are executed in compliance with GMP requirements while supporting timelines for clinical and commercial milestones.
The Principal, QC will provide scientific and strategic guidance and leadership for method validation programs, including the design, execution, and documentation of validation activities for cell-based, flow cytometry-based, and PCR-based release and stability assays. This role requires expertise in authoring CMC quality sections for IND and BLA regulatory submissions and serves as a key QC interface with Regulatory Affairs, QA, and Manufacturing during inspections and agency interactions.
KEY ROLES AND RESPONSIBILITIES:
- Serve as the QC analytical SME for the design, development, and validation strategy for cell therapy release and stability methods, including cell-based potency assays, flow cytometry-based phenotyping, and PCR-based methods (e.g., VCN, residual plasmid).
- Provide technical oversight for method transfers from Analytical Development or external labs, ensuring scientific rigor and regulatory acceptability.
- Lead method qualification or validation strategy in alignment with ICH Q2(R1)/Q2(R2), ICH Q6B.
- Evaluate method performance data critically; provide scientific justification for acceptance criteria, method parameters, and specification setting.
- Serve as QC SME during regulatory agency inspections, partner audits, and internal GMP audits related to analytical methods and testing strategies.
- Author CMC quality sections for IND and BLA submissions, including analytical method descriptions, method validation summaries, specification justifications, and stability program summaries (Module 3).
- Contribute to authoring Contamination Control Strategy (CCS) sections in regulatory filings, in alignment with current regulatory expectations.
- Act as the Quality Control representative on cross-functional project teams supporting product development, tech transfer, method validation, and commercialization activities.
- Serve as Quality Control Subject Matter Expert (SME) for BLA coordination activities.
- Drive continuous improvement initiatives within the QC laboratory, including method lifecycle management, assay robustness improvements, and test efficiency optimization.
- Participate in cross-functional readiness activities to ensure the QC department is prepared for regulatory inspections as applicable.
- Initiate, lead, and contribute to deviations, Change Controls, and CAPAs associated with QC methods, analytical instrumentation, and release testing. Experience with MasterControl is a plus.
KNOWLEDGE, SKILLS AND ABILITIES:
- Expertise in cell therapy QC analytical methods, including flow cytometry, PCR-based assays, and cell-based functional/potency assays.
- Comprehensive knowledge of ICH guidelines applicable to QC, including ICH Q2(R1)/Q2(R2), ICH Q6B, ICH Q1E, ICH Q9, and ICH Q14.
- Proven capability to design and oversee execution of qualification/validation protocols.
- Strong working knowledge of GMP-regulated laboratory operations, GDP principles, and LIMS systems.
- Ability to work effectively both independently and cross-functionally with Analytical Development, Manufacturing, MSAT, Regulatory, Supply Chain, and external partners to set goals, develop sound project plans, monitor progress, and report results.
- Outstanding communication, emotional intelligence and interpersonal skills.
- Curious and proactive mindset with a continuous improvement orientation; actively seeks to understand processes, identify risks, and implement sustainable quality solutions.
- Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
- Excellent analytical skills and scientific/technical expertise.
PREFERRED EDUCATION:
or MSc. in Biology, Immunology, Cell Biology, Biochemistry, Molecular Biology, or a related life sciences field with a minimum of 15 years’ experience;
PREFERRED EXPERIENCE:
- 10-15 years of experience in GMP biopharmaceutical operations including 4 years in cell therapy and/or lentiviral manufacturing operations.
- Minimum of 5+ years in Quality Control
- Direct experience supporting BLA submissions, regulatory filings, and/or health authority inspections.
- Experience in commercial manufacturing and post-approval lifecycle management.
- Familiarity with contamination control principles, including Disinfection Studies, Environmental Monitoring Program and aseptic process simulation.
WEEKEND WORK AND HOLIDAY COVERAGE:
Due to the nature of our autologous cell therapies and the need to deliver life-saving treatments to our patients as timely as possible, weekend work, and holiday work will occasionally be required. We are looking for passionate team members to join our team that are willing to learn, grow, and evolve with us. Part of this evolution will be to work together to continually assess and modify our shift structure to best support delivering these critical products to our patients.
