Manager/Sr. Manager, Drug Product (Solid-Oral Dose) Commercial Manufacturing Operations

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

What You'll Do

This individual will be the account manager for drug product manufacturing at CMOs for BridgeBio’s Attruby program.  Responsibilities include oversight of day-to-day 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 Eidos 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

This is a U.S. based 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 wit