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

BridgeBio Pharma

4d•Hybrid

About The Position

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.

Requirements

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

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

Benefits

Market leading compensation
401K with 100% employer match on first 3% & 50% on the next 2%
Employee stock purchase program
Pre-tax commuter benefits
Referral program with $2,500 award for hired referrals
Comprehensive health care with 100% premiums covered - no cost to you and dependents
Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
Hybrid work model - employees have the autonomy in where and how they do their work
Unlimited flexible paid time off - take the time that you need
Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
Flex spending accounts & company-provided group term life & disability
Subsidized lunch via Forkable on days worked from our office
People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities