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

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

Health & Wellbeing

Skill Development & Career Paths

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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