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

Mavericks Wanted 

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on 
  
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. 

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

Education, Experience & Skills 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.

As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For BridgeBio Full-Time U.S Based Roles:

Financial & Rewards  

• 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  

Health & Well-Being  

• 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)  

• Hybrid work model with flexibility  

• 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  

Skill Development & Career Paths: 

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility 

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching 

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities