Lead Scientist - Commercial Drug Product Oversight

BridgeBio Inc.; San Francisco (CA); Hybrid; USD 175,000 - 185,000; Full time

Benefits offered by this job

Health benefits

401K with employer match

Employee stock purchase program

Pre-tax commuter benefits

Referral program

Subsidized lunch

Job summary

BridgeBio Inc. in San Francisco is seeking a senior professional to oversee commercial drug product manufacturing at CMOs.

You will coordinate with CMC, Supply Chain Operations, QA and regulatory affairs, serving as a key technical liaison between Calcilytix and CMOs. Responsibilities include on-floor oversight for small molecule solid dosage forms, batch review and release, CAPA planning, change controls, investigations, trend analysis, and batch genealogy generation.

Qualifications

• BA/BS degree required in Life Sciences, Engineering, or related field.
• Eight years of pharma industry experience.
• Solid understanding of CMC manufacturing and analytical activities.

Responsibilities

• On-site/CMO oversight of clinical and commercial drug product manufacturing (small molecule solids).
• Batch review and release activities.
• Root-cause analysis and CAPA planning input.
• Process change controls and quality oversight.
• Coordinate external investigations related to OOS/OOT and deviations.
• Trend analysis of testing and process data for commercial products.
• Generate batch genealogy for commercial materials.

Skills

BA/BS degree in Life Sciences/Eng

8+ years pharma industry

cGMP knowledge

Quality management systems

Liaison with CMOs

Willingness to travel 30%

Education

BA/BS degree in Life Sciences or related field

Job description

BridgeBio Inc. in San Francisco is seeking a senior professional to oversee commercial drug product manufacturing at CMOs.

You will coordinate with CMC, Supply Chain Operations, QA and regulatory affairs, serving as a key technical liaison between Calcilytix and CMOs. Responsibilities include on-floor oversight for small molecule solid dosage forms, batch review and release, CAPA planning, change controls, investigations, trend analysis, and batch genealogy generation.