Sr. Mgr/Assoc Dir, Commercial Manufacturing Operations

What You'll Do

This individual will be the key account manager for drug product manufacturing at CMOs for BridgeBio's Ecaleret program (Calcilytix Therapeutics). Responsibilities include oversight of manufacturing activities as the technical and operational lead, which includes commercial routine manufacturing, technical transfer (including process validation activities), documentation review/batch disposition, quality event support etc. This individual will work with colleagues in DP Formulation/CMC, Analytical Operations, Supply Chain, Quality Assurance, Quality Control, RA CMC etc, while serving as an important point of technical contact between Calcilytix and the CMOs.

Responsibilities

• Day to day activity oversight of commercial DP CMOs for small molecule solid-oral dose manufacturing and release of bulk DP, 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 procedure and processes. Ensures delivery of DP batches on time and in full in accordance to 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.
• Identifies and leads key process problem resolution activities and process improvement initiatives, resolves issues. Candidate must have technical (formulation/chemical engineering) background of small molecule tablet manufacturing on commercial, large scale production (process, equipment, analytical etc).
• Create and disseminate technical transfer information and documents required by CMOs for feasibility, transfer, validation and routine manufacturing.
• Partner with CMC/QA/QC/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.

Where You'll Work

Preferably based in San Francisco bay area (requires in-office collaboration 2-3x per week in our San Francisco office) or US-remote role that will require quarterly, or as needed visits to our San Francisco Office.

Who You Are

• BS/MS (Life Sciences, Engineering) with at least 5-7 years relevant experience in commercial bulk DP manufacturing (preferably solid oral dose of small molecule) and analytical activities required in commercial DP manufacturing
• CMO management or experience within manufacturing plant (experience in commercial manufacturing; engineering knowledge at industrial scale).
• 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. 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, such as 21CFR210 and 211, 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; may function as a technical person in plant during production and during tech transfer activities.