AboutBridgeBioPharma, Inc.

BridgeBiois a biopharmaceutical company dedicated to discovering, developing, and delivering transformative medicines for patients living with genetic diseases and genetically defined cancers. Since our founding in 2015, we have built a diverse portfolio of more than 20 drug development programs, ranging from early discovery to late-stage clinical trials, across multiple therapeutic areas including precision oncology, cardiology, endocrinology, neurology, and renal disease. We have already achieved regulatory approval for threetherapiesandcontinue to advance promising science from academia into meaningful treatments for patients worldwide.

Who We Are

BridgeBiois a global biotechnology company withour Global Headquarterslocatedin San Francisco, USA, andourInternational HQlocatedin Zug, Switzerland. Sinceestablishingour Europeanpresencein 2021,we’vebeen building empowered, high-performing teams acrosscountries—experienced colleagues who move quickly, take ownership, and are fueling the company’s international growth.

AtBridgeBio,you’llfind an energetic and collaborative culture where pragmatismmeetsbold decision-making. We embrace uncertainty with confidence, guided by our commitment to making a meaningful impact for patients. Our people are trusted and empowered, united by urgency, purpose, and the drive to advance science for patients around the world.

WhatYou’llDo

This individual will be the key account manager for active pharmaceutical ingredients (API) CMOs and/or regulatory starting materials (RSMs) suppliers forBridgeBioprograms.Responsibilities include oversight of manufacturing activities as the technical and operational lead, whichincludescommercial routine manufacturing, technical transfer (including process validation activities), documentation review, quality event support etc.

Responsibilities

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

WhereYou’llWork

This is a Netherlands-based remote role that may require

around20%oftravel;the successful candidatefunctions as a technical person in plant during production and during tech transfer activities.

Who You Are

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 experiencewith cross-functional CMC experience.Ability to effectivelyinterface withhighly skilled internal staff,ability to buildgood workrelationships while being able to work independentlythrough various interfaces such as SharePoint, MS Teams,Veevaetc.
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 agreementsetc) as well as metric selection,measurementand analysis
Self-motivated individual with strong attention to detail and time management skills with excellent oral and written communication skills

Rewarding Those Who Make the Mission Possible

We havehigh expectationsfor our team members. We make sure those working hard for patients are rewarded and cared for in return. 

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 careerdevelopmentthrough regular feedback, continuouseducationand professional development programs
We celebratestrong performancewith financial rewards, peer-to-peer recognition, and growth opportunities.

Manager, Drug substance, Commercial Manufacturing Operations

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