Associate Director/Director, Drug Product 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 reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

What You'll Do

You will be responsible for the oversight of drug product formulation and manufacturing process development and manufacturing at contract manufacturing organizations while facilitating clinical drug product disposition. You will also work with colleagues in CMC, Supply Chain Operations, Quality Assurance, and CMC-regulatory Affairs, while serving as an important point of technical contact between Calcilytix and contract research and manufacturing organizations.

Responsibilities

Formulation composition and manufacturing process development (experience with modified/extended release is a plus) Person-in-plant oversight of the clinical and commercial drug product manufacturing process at CMOs (especially for small molecule solid oral dosage forms) Perform activities related to batch review & release, deviations, change controls, investigations and other quality related work Participate & provide input to root-cause analysis and CAPA plans Author/update regulatory filings Where You'll Work This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.

Fully remote could be considered for the right candidate.

Who You Are

BS degree in Life Sciences, Engineering, or related field required, advanced degrees preferred · Minimum of twelve (12) years of relevant experience within the pharmaceutical industry required · Solid understanding of CMC manufacturing and analytical activities required in commercial drug product manufacturing, including knowledge of cGMP regulations. · Experience with cGMP quality oversight and on floor production support required · Understanding of Quality Management Systems required · Prior experience as a liaison with solid oral dosage form contract manufacturing organizations required · Experience with polymer characterization (rheology, DSC, TGA), dissolution, extrusion/spraying operations, and enteric coating preferred · Ability to periodically travel (up to 30% at times) 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  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 Health & Wellbeing: 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 #LI-NT1#LI-NT1 #LI-NT1 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.

Below 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 several 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. Salary$158,000—$215,000 USD

BridgeBio Pharma (NASDAQ: BBIO) is a biopharmaceutical company dedicated to advancing a diverse pipeline of medicines that target genetic diseases. Founded in 2015, BridgeBio is committed to developing innovative therapies that address unmet medical needs in various rare and genetic diseases. With a focus on precision medicine and a patient-centered approach, BridgeBio is at the forefront of revolutionizing treatment options for individuals affected by genetic disorders.