Manager, Quality Control (QC) - Gene Therapy

PTC Therapeutics, Inc; Mountain View (CA); Sur place; USD 119 000 - 145 000; Plein temps

Avantages offerts par ce poste

Short- and long-term incentives

Medical insurance

Dental insurance

Vision insurance

Retirement plans

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

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

Formation

Master's in Molecular Biology/Virion/ Biochemistry

Bachelor's in Molecular Biology/Virology/ Biochemistry

Outils

JMP

MiniTab

Description du poste

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

The Manager, Quality Control (QC) - Gene Therapy provides technical support for assigned assays used in the release and stability testing of Gene Therapy clinical products at external vendors. The role is responsible for raw data review, routine data trending, and timely execution of assigned testing deliverables in support of CMC programs. Decision-making is focused on operational and technical execution within established procedures.

The incumbent works cross-functionally with internal and external resources on quality control related issues.

The Manager, Quality Control - Gene Therapy supports adherence to relevant regulatory requirements, and company Standard Operating Procedures (SOPs) as appropriate.

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Oversees and supports assigned QC testing and raw data review activities from external vendors in support of IND and ex-US clinical filings.
• Reviews and approves raw data from validated assays performed at CTOs/CMOs for assigned programs.
• Performs routine stability data entry, trending, and summary reporting.
• Coordinates assigned assay activities at CROs/CMOs, including sample shipments, scheduling, and data receipt.
• Supports method transfer and method validation activities under the direction of senior QC staff; may author sections of protocols and reports.
• Authors and reviews SOPs, test methods, and routine QC documentation.
• Supports OOS/OOT investigations for assigned assays and documents outcomes.
• Contributes content to CMC regulatory sections as assigned.
• Adheres strictly to cGMPs and PTC SOPs.
• Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum level of education and years of relevant work experience.

• A Master's degree in Molecular Biology, Virology, Biochemistry or other related discipline with a minimum of 4 years of QC experience in a pharmaceutical/biotech industry OR a Bachelor's degree in the same disciplines with a minimum of 6 years of QC experience in a pharmaceutical/biotech industry.

Special knowledge or skills needed and/or licenses or certificates required.

• Prior cGMP experience in a QC laboratory, preferably supporting biologics or gene therapy products.
• Hands-on working knowledge of several of the following: cell-based assays, qPCR/ddPCR, HPLC, SEC-UPLC, ELISA, CE-SDS, SDS-PAGE.
• Familiarity with mammalian cell culture.
• Exposure to method validation and/or method transfer activities.
• Familiarity with CRO/CMO interactions.
• Proficiency with Microsoft Office; exposure to statistical tools (JMP, MiniTab) a plus.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Travel requirements

• 0 -5%
• Office-based role

Expected Base Salary Range: $119,400 - $145,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives. All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

EEO Statement

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.