Sr. Mgr/Assoc Dir, Commercial Manufacturing Operations

The role

This individual will serve as the key account manager for drug product manufacturing at CMOs for the Ecaleret program. They will provide technical and operational oversight for commercial routine manufacturing, technical transfer, and documentation review.

What you will do

• Oversee day to day activity of commercial DP CMOs for small molecule solid-oral dose manufacturing and release of bulk DP
• Hold teleconferences with CMO and suppliers and track action items
• Ensure delivery of DP batches on time and in full
• Lead or support documentation review and approval for MBRs, specs, and methods
• Oversee investigations related to deviations and complaints
• Manage the close out of investigations with root cause analysis and CAPAs
• Lead key process problem resolution activities and process improvement initiatives
• Create and disseminate technical transfer information and documents
• Partner with CMC, QA, QC, and RA CMC functions to develop and operate CMC procedures
• Work with supply chain group to design production schedules

Required qualifications

• BS/MS in Life Sciences or Engineering
• 5-7 years relevant experience in commercial bulk DP manufacturing
• Experience in analytical activities in commercial DP manufacturing
• CMO management or experience within manufacturing plant
• Experience in formulation development, process validation and tech transfer in support of marketing applications
• Working knowledge of modern analytical methods pertaining to small molecule DP
• Project leadership experience with cross-functional CMC experience
• Familiarity with FDA and ICH guidelines, such as 21CFR210 and 211
• Thorough understanding of cGMP, quality and regulatory requirements
• Experience preparing and writing key sections of regulatory documents such as NDAs, MAAs and INDs
• Understanding of supplier performance management (KPI, quality metrics, adherence to supply and quality agreements)
• Strong attention to detail, time management, and oral and written communication skills

Nice to have

• preferably solid oral dose of small molecule

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
• Flexible Spending Accounts (FSA)
• Fertility & family-forming benefits
• Expanded mental health support (therapy and coaching resources)
• Hybrid work model with flexibility

About the company

BridgeBio uses a moneyball for biotech approach, pooling projects and promising early-stage research from academia under one financial umbrella. They build bridges to groundbreaking advancements in rare disease and develop medicines for patients with unmet needs.