Manager, QC - Gene Therapy | cGMP & Data Integrity

PTC Therapeutics; Mountain View (CA); Vor Ort; USD 119.000 - 145.000; Vollzeit

Benefits dieser Stelle

Short- and long-term incentives

Medical

Dental

Vision

Retirement savings plans

Zusammenfassung

PTC Therapeutics seeks a Manager, Quality Control - Gene Therapy to provide technical QC support for gene therapy products across external vendors. You will review raw data, trend stability, and ensure timely deliverables for CMC programs while maintaining compliance with SOPs and cGMP requirements.

You will collaborate cross-functionally, oversee testing at CTOs/CMOs, and help drive validation/transfer activities.

Qualifikationen

• A Master's degree in Molecular Biology, Virology, Biochemistry or related with a minimum of 4 years of QC experience in pharma/biotech, OR a Bachelor's with 6 years of QC experience.
• Prior cGMP experience in a QC laboratory, preferably supporting biologics or gene therapy products.
• Hands-on knowledge of cell-based assays, qPCR/ddPCR, HPLC, SEC-UPLC, ELISA, CE-SDS, SDS-PAGE.
• Familiarity with mammalian cell culture and exposure to method validation/transfer.
• Familiarity with CRO/CMO interactions.
• Proficiency with Microsoft Office; JMP/Min iTab a plus.
• Excellent verbal and written communication skills; ability to work independently in a fast-paced team.
• Strong analytical thinking and time management for multiple projects.

Aufgaben

• Oversees QC testing and raw data review from external vendors for IND and ex-US filings.
• Reviews/approves raw data from validated assays at CTOs/CMOs.
• Performs routine stability data entry, trending, and reporting.
• Coordinates assay activities at CROs/CMOs including sample shipments and data receipt.
• Supports method transfer/validation; may author sections of protocols/reports.
• Authors/reviews SOPs and routine QC documentation.
• Supports OOS/OOT investigations and documents outcomes.
• Contributes to CMC regulatory sections; adheres to cGMPs and SOPs.

Kenntnisse

QC experience

cGMP

cell-based assays

qPCR/ddPCR

HPLC

ELISA

CRO/CMO interactions

MS Office

JMP

MiniTab

communication skills

Ausbildung

MS in Molecular Biology, Virology, Biochemistry or related with 4+ QC years

BS in same disciplines with 6+ QC years

Tools

JMP

MiniTab

Jobbeschreibung

PTC Therapeutics seeks a Manager, Quality Control - Gene Therapy to provide technical QC support for gene therapy products across external vendors. You will review raw data, trend stability, and ensure timely deliverables for CMC programs while maintaining compliance with SOPs and cGMP requirements.

You will collaborate cross-functionally, oversee testing at CTOs/CMOs, and help drive validation/transfer activities.