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

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