BridgeBio
Sr. Manager, Commercial Manufacturing Operations
BridgeBio, San Francisco, California, United States, 94199
Sr. Manager, Commercial Manufacturing Operations
Join to apply for the
Sr. Manager, Commercial Manufacturing Operations
role at
BridgeBio .
This range is provided by BridgeBio. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base Pay Range $161,100.00/yr - $183,310.00/yr
What You’ll Do 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.
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
Where You’ll Work This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.
Who You Are
Minimum of Ph.D. (ideally organic chemistry) with 5+ years relevant experience, or BS/MS with 10+ years relevant 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
~20% travel may be required; functions as a technical person in plant during production and during tech transfer activities
Financial 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
Health & Wellbeing
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
Skill Development & Career Paths
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
Salary $161,100 - $183,310 USD
#J-18808-Ljbffr
Sr. Manager, Commercial Manufacturing Operations
role at
BridgeBio .
This range is provided by BridgeBio. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base Pay Range $161,100.00/yr - $183,310.00/yr
What You’ll Do 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.
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
Where You’ll Work This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA office.
Who You Are
Minimum of Ph.D. (ideally organic chemistry) with 5+ years relevant experience, or BS/MS with 10+ years relevant 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
~20% travel may be required; functions as a technical person in plant during production and during tech transfer activities
Financial 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
Health & Wellbeing
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
Skill Development & Career Paths
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
Salary $161,100 - $183,310 USD
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