Senior Scientist / Associate Director, Drug Product Manufacturing
BridgeBio Pharma · CA, US
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About the Role
BridgeBio pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia to reduce risk and unleash innovation. We build bridges to groundbreaking advancements in rare disease and develop life-changing medicines for patients with unmet needs. We empower people to solve problems and invite those who defy convention to join us in reengineering the future of biopharma.
Responsibilities
- Oversight of commercial drug product manufacturing at contract manufacturing organizations.
- Facilitate global commercial drug product disposition.
- Serve as a technical point of contact between Calcilytix and contract manufacturing organizations.
- Person-in-plant oversight of clinical and commercial drug product manufacturing at CMOs.
- Perform activities related to batch review & release.
- Participate and provide input to root-cause analysis and CAPA plans.
- Participate in process confirmations, change controls, & quality oversight.
- Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results.
- Perform trend analysis of testing and process data for commercial drug products.
- Participate in continuous improvement projects.
- Generate batch genealogy for commercial materials.
Requirements
- BA/BS degree in Life Sciences, Engineering, or related field.
- Minimum of eight (8) years of experience within the pharmaceutical industry.
- Solid understanding of CMC manufacturing and analytical activities in commercial drug product manufacturing, including knowledge of cGMP regulations.
- Experience with cGMP quality oversight and on-floor production support.
- Understanding of Quality Management Systems.
- Prior experience as a liaison with solid oral dosage form contract manufacturing organizations.
- Ability to periodically travel (up to 30%).
Skills
- Small molecule solid oral dosage forms manufacturing
- cGMP regulations
- Quality Management Systems
- AI for clarity, speed, and quality of work
Location
- San Francisco Office
Work Type
- Hybrid
Experience Level
- 8+ years
Education Level
- BA/BS degree
Salary/Compensations
- $175,000—$185,000 USD
Benefits
- Market leading compensation
- 401K with 100% employer match on first 3% & 50% on the next 2%
- Employee stock purchase program
- Pre-tax commuter benefits
- Referral program with $2,500 award for hired referrals
- Comprehensive health care with 100% premiums covered
- Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
- 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
- Subsidized lunch via Forkable on days worked from our office
- Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
- 401(k) with employer match
- Employee Stock Purchase Program (ESPP)
- Pre-tax commuter benefits (transit and parking)
- Referral bonus for hired candidates
- Subsidized lunch and parking on in-office days
- 100% employer-paid medical, dental, and vision premiums for you and your dependents
- Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
- Fertility & family-forming benefits
- Expanded mental health support (therapy and coaching resources)
- Flexible, “take-what-you-need” paid time off and company-paid holidays
- Comprehensive paid medical and parental leave to care for yourself and your family
- Annual performance bonus
- Company equity
About the Company
- Calcilytix
- BridgeBio is a global company.