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.
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary
$260,000-$278,100 USD
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
