About this opportunity
BridgeBio Inc. lists this Senior Scientist / Associate Director, Drug Product Manufacturing New San Francisco - 1800 Owens opportunity in san francisco, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Senior Scientist / Associate 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 allowsscience and small teams of experts to lead the way. We build bridges to groundbreaking advancements in raredisease, anddevelop 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'llask"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.
Company Overview
Calcilytix
What You’ll Do
You will be responsible for the oversight of commercial drug product manufacturing at contract manufacturing organizations while facilitating global commercial 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 manufacturing organizations.
Responsibilities
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
Participate & provide input to root-cause analysis and CAPA plans
Participate in process confirmations, change controls, & quality oversight
Coordinate investigations at external sites related to OOS/OOT, deviations, and unexpected analytical results
Perform trend analysis of testing and process data for commercial drug products and participate in continuous improvement projects
Generate batch genealogy for commercial materials
Where You’ll Work
This is a hybrid role and requires in-office collaboration 2-3x per week in our San Francisco Office.
Who You Are
BA/BS degree in Life Sciences, Engineering, or related field required
Minimum of eight (8) years of 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
Ability to periodically travel (up to 30%)
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. 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.
$175,000 - $185,000 USD
As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.
For BridgeBio Full-Time U.S Based Roles:
Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
HealthSavings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family
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, continuouseducationand professional development programs via LinkedIn Learning,LifeLabs, &BetterUpCoaching
We celebratestrong performancewith financial rewards, peer-to-peer recognition, and growth opportunities
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.