BridgeBio

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

BridgeBio

full-time

Posted on:

Location Type: Hybrid

Location: California • United States

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Salary

💰 $129,000 - $177,000 per year

Job Level

Senior

About the role

  • 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

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
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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
formulation developmentprocess validationtechnical transferanalytical methodssmall molecule manufacturingbulk drug product manufacturingroot cause analysisCAPAcommercial manufacturingquality metrics
Soft Skills
project leadershipinterpersonal skillsindependent workattention to detailtime managementoral communicationwritten communicationrelationship buildingproblem resolutionself-motivation