Sr. Manager, Commercial Manufacturing Operations

Role Summary

The Sr. Manager, Commercial Manufacturing Operations will serve as the technical lead and key account manager for small molecule API CMOs and/or regulatory starting materials suppliers supporting BridgeBio programs. Responsibilities include oversight of manufacturing activities as the technical (process chemistry/chemical engineering) and operational lead, covering commercial routine manufacturing, technical transfer (including process validation activities), documentation review, and quality event support.

Responsibilities

• Management of commercial API CMOs and RSM suppliers from raw material ordering oversight to manufacturing and release of API, in collaboration with various CMC functions
• Holds teleconferences with CMO and suppliers; takes meeting minutes, tracks action items, creates workflows for complex and interdisciplinary CMC procedures and processes. Ensures delivery of API on time and in full in accordance with supply plans.
• Leads or supports documentation review and approval (MBRs, specs, methods), change controls and documentation for batch disposition.
• Oversees investigations related to deviations and complaints, with proper evaluation of impact to product and processes. Manages the close out of the investigations in a timely manner with the proper root cause analysis and establishment of appropriate CAPAs.
• Create and disseminate technical transfer information and documents required by CMOs for feasibility, transfer, validation and routine manufacturing.
• Identifies and leads key process problem resolution activities and process improvement initiatives, resolves issues.
• Partner with QA/RA CMC functions to develop and operate appropriate CMC procedures, ensure product meets established quality standards, adheres to established approved parameters filed in various regions. Works closely with supply chain group to design production schedules while maximizing production and cost efficiencies.

Qualifications

• Ph.D. (ideally organic chemistry or chemical engineering) with 5+ years relevant experience (process chemistry or plant operations), or BS/MS (chemistry) with 10+ years relevant experience
• Demonstrated track record of commercial API CMO management or experience in CMO with experience in commercial manufacturing (chemistry and/or engineering knowledge at industrial scale; plant experience is a plus). Experience in chemical development, process validation and tech transfer in support of marketing applications. Working knowledge of modern analytical methods pertaining to small molecule drug substance
• Project leadership experience with cross-functional CMC experience. Ability to effectively interface with highly skilled internal staff, ability to build good work relationships while being able to work independently
• Familiarity with FDA and ICH guidelines, with focus in ICH Q7 and thorough understanding of cGMP, quality and regulatory requirements, including the preparation and writing of 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 etc) as well as metric selection, measurement and analysis
• Self-motivated individual with strong attention to detail and time management skills with excellent oral and written communication skills
• Up to 25% travel may be required; functions as a technical person in plant during production and during tech transfer activities