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

BridgeBio
San Francisco
Workplace: HybridFull timeUSD 260,000 - 278,100 annuallyFunction: Executive & General ManagementExperience: 12+ yearsEducation: phdSkills: ["Leadership","Cross-functional collaboration","Written communication","Oral communication","Issue resolution"]

Lead CMC drug product technical activities across CDMOs, including CTM production, process troubleshooting, risk assessments, registration batch production, and process validation. Provide technical direction to ensure timelines and performance, resolve formulation and transfer issues, and develop scalable manufacturing processes. Author and review CMC regulatory filing sections (IND/IMPD amendments/NDA- MAA), coordinate with Quality and Supply Chain for batch release, and ensure strict adherence to cGMP, FDA/EMA/ICH/GCP/GMP requirements.

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BridgeBio
BridgeBio
1 day ago

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

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Last checked: 19 minutes agoStatus: Live

Job Summary

Lead CMC drug product technical activities across CDMOs, including CTM production, process troubleshooting, risk assessments, registration batch production, and process validation. Provide technical direction to ensure timelines and performance, resolve formulation and transfer issues, and develop scalable manufacturing processes. Author and review CMC regulatory filing sections (IND/IMPD amendments/NDA- MAA), coordinate with Quality and Supply Chain for batch release, and ensure strict adherence to cGMP, FDA/EMA/ICH/GCP/GMP requirements.
Location: San Francisco
Workplace: Hybrid
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Sr. Director level

Key Responsibilities

  • •Oversee technical activities at drug product CDMOs, including CTM production, process troubleshooting, risk assessments, registration batch production, and process validation.
  • •Provide technical and scientific direction to CDMOs and external laboratories to meet project deadlines and performance standards.
  • •Lead issue resolution with CDMOs, including formulation challenges, technical transfer, design of experiments, and interpretation of results.
  • •Develop and optimize scalable processes to produce CTM while ensuring product quality and executing process validation strategies.
  • •Oversee CMC document preparation for regulatory submissions and coordinate with Quality and Supply Chain on batch records, deviations, change controls, and nonconformance investigations.

Pay and Benefits

Salary: USD 260,000 - 278,100 annually
Equity and Bonus:Equity
Perks:401kEquityAnnual BonusHealth InsuranceDentalVisionHsaPaid LeaveHybrid Work

Key Requirements

  • •PhD in chemistry, pharmaceutical sciences, or related field preferred.
  • •12+ years of relevant industry experience (8+ years focused on antibodies).
  • •Experience managing CDMO work from cell line development through successful IND/FIH.
  • •Thorough knowledge of cGMPs, USP, and ICH guidelines and industry best practices.
  • •Direct experience with CMC regulatory requirements for IND and NDA/MAA filing, including communicating effectively with CRO/CDMO/CMO.
Experience:12+ yearsBiotechBiologicsAntibodiesCMCCDMO
Education:PhD / Doctorate
Skills:LeadershipCross-functional collaborationWritten communicationOral communicationIssue resolution
Tech Stack:HPLCCE-SDSIcIEFLC-MSSECParticle analysisDSCINDIMPDNDAMAAFDAEMAICHGCPGMPCGMP

Company Brief

BridgeBio
Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Palo Alto, United States
Founded: 2015
WebsiteLinkedIn