BridgeBio Pharma is hiring a Manager or Sr. Manager of Quality Control to join our Quality Control group supporting BridgeBio subsidiaries. You will play a key role in ensuring all analytical activities at Contract Manufacturing Organizations are conducted in compliance with cGMP. Your primary focus will be the critical review of analytical test data for release, in-process, and stability testing of both drug substance and drug product.
What You'll Do
- Review analytical data for release, stability, and in-process testing at CMOs in a timely manner.
- Provide oversight of laboratories, including managing investigations for out of specification results, deviations, and anomalous data.
- Follow up with contract laboratories to correct any deficiencies or omissions in test packages.
- Submit reviewed test packages to QA and load all data into the electronic storage program.
- Review analytical data related to reference standard qualification, method validation, and method transfer activities.
- Travel to analytical testing sites or other locations as necessary.
What We're Looking For
- 5+ years of experience in Quality Control within a pharmaceutical setting, with solid knowledge of Good Manufacturing Practices (cGMP).
- 2+ years of management experience.
- Demonstrated strong analytical skills with the ability to work independently against multiple deadlines.
- Excellent organizational and planning skills with high attention to detail.
- Sophisticated understanding of how and when to appropriately apply cGMP requirements, including the ability to distinguish regulated from non-regulated activities.
- Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates.
Nice to Have
- M.S. or B.S. in life sciences, ideally Chemistry or Analytical Chemistry.
Benefits & Compensation
- Compensation range: $129,200 - $159,700 USD
- Market-leading compensation package.
- 401K with 100% employer match on first 3% & 50% on the next 2%.
- Employee stock purchase program.
- Pre-tax commuter benefits.
- Referral program with a $2,500 award for hired referrals.
- Comprehensive health care with 100% premiums covered - no cost to you and dependents.
- Mental health support via Spring Health (6 therapy & 6 coaching sessions).
- Hybrid work model with autonomy in where and how you work.
- Unlimited flexible paid time off.
- Paid parental leave: 4 months for birthing parents & 2 months for non-birthing parents.
- Flex spending accounts & company-provided group term life & disability insurance.
- Subsidized lunch via Forkable on days worked from the office.
- Career pathing via regular feedback, continuous education, and development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp.
- Celebration of performance with financial rewards, peer recognition, and growth opportunities.
Work Mode
This role follows a hybrid work model, with employees having autonomy in where and how they work. The position is open to U.S.-based remote candidates.
BridgeBio Pharma is an equal opportunity employer.
