Sr. Manager / Associate Director, Drug Substance Manufacturing

Sr. Manager / Associate Director, Drug Substance Manufacturing

Join BridgeBio to apply for the Sr. Manager / Associate Director, Drug Substance Manufacturing role.

Base pay range

$173,060.00 / yr - $210,980.00 / yr

What You'll Do

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.

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, maintaining in depth knowledge of chemical steps, manufacturing processes, and quality controls.

Establish and maintain business relationships with CROs and CMOs appropriately for process validation and commercial supply requirements.

Lead late-stage drug substance process finalisation, validation, and commercial-scale manufacturing.

Identify and lead key process problem resolution activities and process improvement initiatives.

Work closely with Quality Assurance to develop and operate appropriate CMC procedures, ensuring product meets established quality standards.

Create and disseminate technical transfer information required by CROs and CMOs to develop and scale up chemical processes and validate analytical methods.

Support authorship, review, and response to queries on all Module 3 drug substance development sections of the CTD, contributing to the overall regulatory control strategy.

Support a culture of continuous improvement and high-performance teamwork.

Where You'll Work

This hybrid role requires in-office collaboration 2–3 x per week in our San Francisco Office.

Who You Are

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.

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 and thorough understanding of cGMP, quality and regulatory requirements for drug substance manufacturing.

Ability to effectively interface with and / or manage highly skilled internal staff.

Team-oriented, self-motivated, excellent oral and written communication skills, strong attention to detail and time-management.

Up to 20 % travel may be required.

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.

401(k) with 100 % employer match on first 3 % and 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.

Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions).

Hybrid work model – employees have autonomy where and how they do their work.

Unlimited flexible paid time off.

Paid parental leave – 4 months for birthing parents and 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 – endless opportunities for skill development and internal mobility from discovery to active drug trials and FDA pipelines.

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.

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity and generous health benefits. This salary range applies to candidates working in California. The final salary offered to a successful candidate will depend on several factors, including experience, educational background, location, and interview performance.

Seniority level

Director

Employment type

Full-time

Job function

Management and Manufacturing

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