Senior Scientist / Associate Director, Drug Product Manufacturing

BridgeBio Pharma•San Francisco, CA

1d•$175,000 - $185,000•Hybrid

About The Position

In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

Requirements

BA/BS degree in Life Sciences, Engineering, or related field required.
Minimum of eight (8) years of experience within the pharmaceutical industry required.
Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations.
Experience with cGMP quality oversight and on floor production support required.
Understanding of Quality Management Systems required.
Prior experience as a liaison with solid oral dosage form contract manufacturing organizations required.
Ability to periodically travel (up to 30%).

Responsibilities

Oversight of commercial drug product manufacturing at contract manufacturing organizations while facilitating global commercial drug product disposition.
Serve as an important point of technical contact between Calcilytix and contract manufacturing organizations.
Person-in-plant oversight of the clinical and commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms).
Perform activities related to batch review & release.
Participate & 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 and participate in continuous improvement projects.
Generate batch genealogy for commercial materials.

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 - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
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
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