Senior Scientist / Associate Director, Drug Product Manufacturing

The role

You will oversee commercial drug product manufacturing at contract manufacturing organizations and facilitate global commercial drug product disposition. You will serve as a technical contact between Calcilytix and contract manufacturing organizations while working with CMC, Supply Chain, Quality, and Regulatory teams.

What you will do

• Person-in-plant oversight of clinical and commercial drug product manufacturing process at CMOs
• Perform activities related to batch review and release
• Provide input to root-cause analysis and CAPA plans
• Participate in process confirmations, change controls, and 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
• Participate in continuous improvement projects
• Generate batch genealogy for commercial materials

Required qualifications

• BA/BS degree in Life Sciences, Engineering, or related field
• Minimum of eight (8) years of experience within the pharmaceutical industry
• Solid understanding of CMC manufacturing and analytical activities in commercial drug product manufacturing
• Knowledge of cGMP regulations
• Experience with cGMP quality oversight and on floor production support
• Understanding of Quality Management Systems
• Prior experience as a liaison with solid oral dosage form contract manufacturing organizations
• Ability to periodically travel (up to 30%)

Benefits

• Market leading compensation
• 401K with 100% employer match on first 3% and 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• 100% employer-paid medical, dental, and vision premiums for employees and dependents
• Mental health support via Spring Health
• Unlimited flexible paid time off
• Paid parental leave (4 months for birthing parents, 2 months for non-birthing parents)
• Flex spending accounts
• Company-provided group term life and disability
• Subsidized lunch via Forkable on in-office days

About the company

BridgeBio uses a moneyball for biotech approach, pooling projects and early-stage research from academia to reduce risk and unleash innovation. They develop medicines for rare diseases and unmet needs.