BridgeBio

Manager, Drug Substance – Commercial Manufacturing Operations

BridgeBio

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇳🇱 Netherlands

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Job Level

JuniorMid-Level

About the role

  • This individual will be the key account manager for active pharmaceutical ingredients (API) CMOs and/or regulatory starting materials (RSMs) suppliers for BridgeBio programs. 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, quality event support etc.
  • 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 procedure 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
  • Understanding of regulatory filings and translation to production activities; support authorship, review and response to queries on Module 3 drug substance development sections of CTD
  • Create a culture of continuous improvement and high-performance teamwork

Requirements

  • Ph.D. (ideally organic chemistry) with 2+ years relevant experience, or BS/MS with 5+ years relevant experience or process chemistry 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 through various interfaces such as SharePoint, MS Teams, Veeva etc.
  • Familiarity with FDA and ICH guidelines, with focus in ICH Q7 and thorough understanding of cGMP, quality and regulatory requirements
  • 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.
Benefits
  • Market leading compensation
  • Hybrid work model - we value your flexibility in how you work, but encourage time in the office to strengthen our culture, collaboration, and sense of community
  • We provide career development through regular feedback, continuous education and professional development programs
  • We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities.

Applicant Tracking System Keywords

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

Hard skills
commercial API managementprocess validationtechnical transferchemical developmentanalytical methodsproject leadershipsupplier performance managementKPI analysisquality metricscGMP compliance
Soft skills
attention to detailtime managementoral communicationwritten communicationrelationship buildingindependent workteamworkproblem resolutioncontinuous improvementorganizational skills
Certifications
Ph.D. in organic chemistryBS/MS in relevant field