Our client is a small biopharmaceutical company developing monoclonal antibody therapies to treat patients with cardiovascular diseases. Their lead program is currently in Phase 2 clinical trials. They are seeking a Senior/Principal Scientist, Process Engineering to support production of their lead program as it heads to pivotal trials.
Location: Remote
Reports to: Head of CMC
Must-Have:
- PhD with 4+ years industry experience, MS with 6+ years industry experience, or BS with 8+ years' experience
- Experience in process engineering (preferable upstream) for late-stage biologics production
- Experience overseeing CDMO partners with responsibilities including technology transfer, PIP, and troubleshooting
- Excellent analytical, troubleshooting, and problem-solving skills.
- Strong attention to detail
Like-to-have:
- Cross functional experience in CMC (Analytical, DS/DP Mfg., Process Development/Engineering, PM, etc.)
- Experience in both small and large biotechnology organizations
- Previous project management experience
- Experience designing and leading stability studies
Responsibilities:
- Work closely with the Head of CMC to guide and manage CDMO partners in the production of monoclonal antibodies to support late-stage/pivotal trials
- Monitor, review, and provide technical input on process performance data from CDMOs, identifying and troubleshooting any manufacturing issues
- Take on technology transfers to, from, and in between CDMO partners at various scales
- Proactively identify and mitigate risks associated with process development and scale-up for clinical and commercial manufacturing.
- Lead or contribute to root-cause analysis and resolution of process or manufacturing challenges in collaboration with CDMO partners.
- Support oversight or ongoing stability studies
- Support data generation for and authoring of late-stage regulatory documentation (BLA, etc.)
- Support the development and execution of process validation (CPV, PPQ) and process characterization studies
- Track deliverables, maintain timelines, and help maintain budgets to ensure programs remain on track for commercial goals (i.e. spend projections for BLA, etc.)
- Will be a high level individual contributor, as company will remain lean
- Up to 25% travel
- Attend quarterly team meetings in company headquarters
