Sr. Director/ Exec. Director- CMC, Drug Product

BridgeBio Pharma•San Francisco, CA

12d•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

PhD in chemistry, pharmaceutical sciences, or related field preferred; 12+ years of relevant industry experience (8+ years focused on antibodies)
Ability to communicate effectively with CRO/CDMO/CMO regarding project scope, scientific results and project updates
Experience managing CDMO from cell line development to successful IND/FIH
Knowledge of analytical methods for biologics: HPLC, CE-SDS, icIEF, LC-MS, SEC, particle analysis, DSC. Familiarity with characterization of glycoslation, post-translational modifications, and degradation pathways.
Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.
Knowledge and direct experience with CMC regulatory requirements for IND and NDA/MAA filing
Proven leadership and team management; ability to drive cross-functional projects under time pressure.
Excellent written and oral communication skills; comfort presenting to regulatory agencies and CDMOs.
Self-starter who thrives in a fast-moving environment and can partner effectively with program leadership.

Responsibilities

Oversee technical activities at drug product CDMOs including clinical trial material (CTM) production, process troubleshooting, risk assessments, registration batch production, and process validation
Provide technical and scientific direction to CDMOs and external laboratories to ensure project deadlines and performance standards are met
Responsible for technical leadership in issue resolution with CDMOs, including formulation challenges, technical transfer, design of experiments, and interpretation of results
Lead the development/optimization of scalable, efficient, and cost-effective processes to produce CTM while ensuring product quality
Lead process validation activities and strategies including establishing and evaluating process characterization plans, overseeing execution at CDMO, reviewing and approving CDMO reports
Oversee the preparation of manufacturing batch records, technical reports, data summaries and CMC related documents required for various regulatory submissions
Coordinate with Quality and Supply Chain teams to ensure timely manufacture and release of drug product lots by leading technical reviews of batch records, deviations, change controls, and nonconformance investigations; proactively identify and mitigate risks related to clinical supply
Manage related SOPs, change controls, deviations and CAPAs with thorough knowledge of Good Manufacturing Practices
Ensure adherence to applicable regulations and guidelines, including FDA, EMA, ICH, GCP, and GMP
Author and review CMC sections of regulatory filings, including INDs, IMPD/IND amendments, and NDA/MAA submissions

Benefits

Market-leading compensation
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
Career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching
Financial rewards, peer-to-peer recognition, and growth opportunities