BridgeBio · 1 month ago
Sr. Manager/Associate Director, Drug Substance Manufacturing
San Francisco - 1800 Owens
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$173K/yr - $211K/yr
7+ years expBridgeBio is a pioneering biotech company focused on developing life-changing medicines for patients with unmet needs. The Sr. Manager/Associate Director will manage outsourced drug substance manufacturing activities, ensuring quality and compliance throughout the product lifecycle while supporting regulatory submissions.
BiotechnologyHealth CareLife ScienceMedicalPharmaceutical
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
Qualification
Required
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
Benefits
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
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
Company
BridgeBio
BridgeBio focuses on the development and commercialization of precision medicines for various genetic diseases and cancers.
201-500 employees
H1B Sponsorship
BridgeBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (5)
2023 (4)
2022 (4)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$4.35BKey Investors
Blue OwlQatar Investment AuthorityKohlberg Kravis Roberts
2025-02-25Post Ipo Debt· $500M
2024-03-04Post Ipo Equity· $250M
2024-01-18Post Ipo Debt· $1.25B
Leadership Team
Justin To
CEO, Skeletal Dysplasias (QED Therapeutics)
Neil Kumar
CEO and Founder
Recent News
2026-01-05
2025-12-24
2025-12-11
Company data provided by crunchbase