Sr. Manager/Associate Director, Drug Substance Manufacturing

BridgeBio Pharma, Inc.•San Francisco, CA

47d•Hybrid

About The Position

Sr. Manager/Associate Director, Drug Substance Development and Manufacturing will support ML Bio Solutions, a subsidiary of BridgeBio Pharma. This position will be responsible for managing outsourced drug substance manufacturing activities at contract suppliers, including process validation, manufacture of raw materials and drug substance for commercial launch, and tech transfer to new vendors to build and maintain the commercial supply chain throughout the product lifecycle. The position will also support submission of global marketing authorization applications and responses to health agency queries.

Requirements

Minimum of a PhD (ideally chemistry or chemical engineering) with 7+ years relevant experience, or a BS/MS with 10+ years relevant experience
Demonstrated chemistry development at an industrial scale
Demonstrated experience in managing drug substance chemical development, process validation, and manufacturing in support of marketing applications and commercial production
Strong aptitude and demonstrated experience in synthetic organic chemistry
Working knowledge of analytical method development and validation
Familiarity with FDA and ICH guidelines for INDs/NDAs/MAAs. Thorough understanding of cGMP, quality, and regulatory requirements for drug substance manufacturing
Ability to effectively interface with and/or manage highly skilled internal staff
Ability to work independently and in a team. Ability to build good work relationships
Strong attention to detail and time management skills. Excellent oral and written communication skills
Up to 20% travel may be required

Responsibilities

Manage multiple CMOs and CROs to deliver bulk starting materials, intermediates, and drug substance of sufficient quality and quantity to meet corporate and regulatory requirements. Maintain in-depth knowledge of chemical steps, manufacturing processes, and quality controls
Establish and maintain business relationships with CROs and CMOs that are appropriate for performing process validation and commercial supply requirements
Lead late-stage drug substance process finalization, validation, and commercial-scale manufacturing
Identify and lead key process problem resolution activities and process improvement initiatives
Work closely with Quality Assurance function to develop and operate appropriate CMC procedures, and to ensure product meets established quality standards
Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and develop and validate analytical methods
Support authorship, review, and response to queries on all Module 3 drug substance development sections of CTD. Contribute to the overall regulatory control strategy
Support a culture of continuous improvement and high-performance teamwork

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
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