Sr. Manager / Associate Director, Drug Substance Manufacturing

Sr. Manager / Associate Director, Drug Substance Manufacturing

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 re‑engineer the future of biopharma.

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. 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

Where You’ll Work

This hybrid role requires in‑office collaboration 2–3x 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

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

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.

Market‑leading compensation

401K with 100% employer match on first 3% & 50% on the next 2%

Employee stock purchase program

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

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

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. The following is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on a number of factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi‑state employer, and this salary range may not reflect positions based in other states.

$173,060 – $210,980 USD

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