New · posted Oct 29
PTC Therapeutics · Biotechnology
Manager, Quality Control (QC) – Gene Therapy
- Mountain View, CA
- On-site
- Full-time
- Manager
The role
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.
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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
What you need
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
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.
What you'll do
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.
Pay and benefits
$119,400 – $145,000 a year
Employer providedExpected 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.
Short- and long-term incentives
Medical insurance
Dental insurance
Vision insurance
Retirement savings plan
Where you'll work
Mountain View, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Mountain View, CAEqual opportunity, accessibility and legal noticesPTC Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 30, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Quality Control roles at this level.
This roleEmployer provided
Manager roles in California8 roles publishing pay
Manager roles in the US30 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $119,400 | — | $145,000 |
| California (middle half) | $102,500 | $123,750 | $134,000 |
| All US (middle half) | $102,750 | $112,000 | $130,625 |
This role: PTC Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 30, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 349 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not PTC Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 32 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods12
- Documentation and SOPs7
- Collaboration and leadership5
- Validation and qualification3
- GMP and compliance1
- Investigations and CAPA1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
Company hiring pulse
PTC Therapeutics on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 3
- Locations
By discipline
- Regulatory2 67%
- Quality1 33%
By level
- Manager2 67%
- Director1 33%
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Manager, Quality Control (QC) – Gene Therapy at PTC Therapeutics
Open until filled. $119K–$145K a year, employer provided.