Sr. Manager, Commercial Manufacturing Operations

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on
 
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 
 
Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.          

What You'll Do

This individual will be the technical lead and key account manager for small molecule active pharmaceutical ingredients (API) CMOs and/or regulatory starting materials (RSMs) suppliers for BridgeBio programs.  Responsibilities include oversight of manufacturing activities as the technical (process chemistry/chemical engineering) 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

• Ph.D. (ideally organic chemistry or chemical engineering) with 5+ years relevant experience (process chemistry or plant operations), or BS/MS (chemistry) 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
• Familiarity with FDA and ICH guidelines, with focus in ICH Q7 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; functions as a technical person in plant during production and during tech transfer activities
• You have demonstrated curiosity and adaptability in adopting AI-powered tools and technologies         

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

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

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