Associate Director / Senior Manager

BridgeBio
San Francisco
Workplace: HybridFull timeUSD 173,100 - 215,000 annuallyFunction: Executive & General ManagementExperience: 5-7 yearsEducation: bachelorsSkills: ["Project leadership","Cross-functional collaboration","Independent work","Attention to detail","Communication"]

Oversee commercial drug product manufacturing at CMOs for a BridgeBio rare-disease program, acting as a technical and operational lead for bulk DP manufacturing and release. Manage day-to-day CMO activities, document review and batch disposition, change controls, and deviation/complaint investigations with CAPA closeout. Lead technical transfer, process validation support, and process improvement initiatives in collaboration with cross-functional CMC, Analytical Operations, Supply Chain, QA/QC, and RA CMC teams.

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FursaFursa
BridgeBio
BridgeBio
15 hours ago

Associate Director / Senior Manager

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Last checked: 3 hours agoStatus: Live

Job Summary

Oversee commercial drug product manufacturing at CMOs for a BridgeBio rare-disease program, acting as a technical and operational lead for bulk DP manufacturing and release. Manage day-to-day CMO activities, document review and batch disposition, change controls, and deviation/complaint investigations with CAPA closeout. Lead technical transfer, process validation support, and process improvement initiatives in collaboration with cross-functional CMC, Analytical Operations, Supply Chain, QA/QC, and RA CMC teams.
Location: San Francisco
Workplace: Hybrid
Employment Type: Full time
Job Function: Executive & General Management
Seniority: Sr. Manager level

Key Responsibilities

  • •Oversee day-to-day commercial DP CMO activities for small-molecule solid oral dose manufacturing and bulk DP release, collaborating across CMC functions.
  • •Hold teleconferences with CMOs and suppliers, track action items, and build workflows for complex CMC procedures and processes to deliver batches on time.
  • •Lead documentation review and approval for MBRs, specs, methods; manage change controls and documentation for batch disposition.
  • •Oversee deviations and complaints, including impact evaluation, root-cause analysis, and timely CAPA establishment and closeout.
  • •Create and disseminate technical transfer documents for feasibility, transfer, validation, and routine manufacturing; partner on CMC procedure development and production scheduling.
Travel: Medium travel

Pay and Benefits

Salary: USD 173,100 - 215,000 annually
Equity and Bonus:Equity
Perks:Health InsuranceDentalVision401kEquityEsppHsaFsaParental LeavePaid LeaveHybrid Work

Key Requirements

  • •BS/MS in Life Sciences or Engineering with at least 5-7 years relevant experience in commercial bulk drug product manufacturing.
  • •Commercial, large-scale small-molecule solid oral dose manufacturing experience covering process, equipment, and analytical activities.
  • •Experience with formulation development, process validation, and technical transfer for marketing applications and modern analytical methods for small-molecule DP.
  • •Experience leading projects with cross-functional CMC involvement and the ability to interface with internal experts independently.
  • •Familiarity with FDA and ICH guidance (including 21CFR210 and 21CFR211) and thorough understanding of cGMP, quality, and regulatory requirements.
Experience:5-7 yearsBiotechDrug product manufacturingCMO managementSmall moleculeSolid oral dose
Education:Bachelor's
Skills:Project leadershipCross-functional collaborationIndependent workAttention to detailCommunication
Tech Stack:FDAICHCGMP21CFR21021CFR211CAPA

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