Gene Therapy QC Manager - Data Review & CRO Coordination

PTC Therapeutics, Inc; Mountain View (CA); In loco; USD 119.000 - 145.000; Tempo pieno

Vantaggi offerti da questo lavoro

Short- and long-term incentives

Medical insurance

Dental insurance

Vision insurance

Retirement plans

Descrizione del lavoro

PTC Therapeutics, Inc. seeks a Manager, Quality Control (Gene Therapy) to provide technical QC support for gene therapy clinical products across external vendors. The role focuses on data review, trending and timely testing deliverables within cGMPs.

You will collaborate cross-functionally with internal and external teams, author SOPs and support method validation/transfer while ensuring regulatory compliance and timely delivery of QC data.

Competenze

• Master's degree with 4+ years QC experience or Bachelor's with 6+ years QC in pharma/biotech.
• Experience with cGMP in QC lab, preferably for biologics or gene therapy.
• Hands-on knowledge of cell-based assays, qPCR/ddPCR, HPLC, SEC-UPLC, ELISA, CE-SDS, SDS-PAGE.

Mansioni

• Oversee QC testing and raw data reviews from external vendors for IND/ex-US filings.
• Review/approve raw data from validated assays at CTOs/CMOs.
• Perform routine stability data entry, trending and reporting.
• Coordinate assay activities at CROs/CMOs and data receipt.

Conoscenze

QC testing

data trending

data review

oral and written comms

independent work

problem solving

time management

team collaboration

cGMP

qPCR/ddPCR

HPLC

SEC-UPLC

ELISA

CE-SDS

SDS-PAGE

mammalian cell culture

method validation/transfer

CRO/CMO interactions

Formazione

Master's in Molecular Biology/Virion/ Biochemistry

Bachelor's in Molecular Biology/Virology/ Biochemistry

Strumenti

JMP

MiniTab

Descrizione del lavoro

PTC Therapeutics, Inc. seeks a Manager, Quality Control (Gene Therapy) to provide technical QC support for gene therapy clinical products across external vendors. The role focuses on data review, trending and timely testing deliverables within cGMPs.

You will collaborate cross-functionally with internal and external teams, author SOPs and support method validation/transfer while ensuring regulatory compliance and timely delivery of QC data.