Principal, Quality Control

About the role

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).

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 release and stability assays.
• 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.
• 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.

Qualifications

• 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.

Skills

• Experience with MasterControl is a plus.