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Senior Pharmaceutical Development Scientist
2 weeks ago
About the Role:
The High Potency Active Pharmaceutical Ingredients (HPAPI) specialist will be responsible for leading development projects in a high-containment laboratory. This includes route scouting and development, proof-of-concept studies, crystallization optimization, and process safety assessments.
Key Responsibilities:
- Work with R&D chemists to lead development projects in the high-containment laboratory.
- Identify and implement new technologies to support business needs.
- Collaborate with operations engineers to ensure laboratory-developed processes can be implemented successfully in the manufacturing plant.
- Collaborate with R&D project leads, project management group, and other functions to ensure project milestones are delivered on time.
- Work cross-functionally to ensure project documentation and campaign readiness activities are completed on time.
- Manufacture batches in the GMP kilo lab facility and bring new technology on site.
- Work with SHE to ensure containment practices meet industry standards and expectations.
- Act as a key member of the high potency audit team.
- Assist in preparing request for information and process RFIs/RFPs for new product introductions.
- Work with customers on development projects to ensure final processes meet their expectations.
- Act as product lead for specific API products, providing technical support for manufacture.
- Lead optimization projects on throughput and yield in collaboration with operations engineers.
- Participate in cross-functional manufacturing campaign performance support teams and project teams.
- Lead and support quality and safety investigations as required.
