Principal, Quality Control

Expertise in cell therapy QC analytical methods, including flow cytometry, PCR-based assays, and cell-based functional/potency assays.

Proven capability to design and oversee execution of qualification/validation protocols.

Strong working knowledge of GMP-regulated laboratory operations, GDP principles, and LIMS systems.

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.

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).