KBI: US - Process Development Principal Scientist
About The Position
The Principal Scientist serves as a downstream purification development scientific leader and reports to the head of downstream process development. The role executes laboratory operations and establishes standards for purification workflows and their presentation to clients. The position owns product process development, including development and design decisions, with minimal oversight. It applies advanced scientific principles to design and conduct unit-operation development and optimization studies and to solve increasingly complex problems. The scientist has broad functional-area knowledge, including phase-appropriate practices, and authors and reviews technical protocols, reports, and other documents that meet process development compliance and quality standards. The work includes process development and support for technology transfer in preparation for cGMP production. The Principal Scientist mentors, trains, and supervises junior staff, helps manage team expectations and development, and supports achievement of individual and group goals. The role provides technical expertise and may support troubleshooting or activities beyond an individual program. It also maintains training compliance according to site expectations. This is a salaried exempt role that may require shift work as needed to support laboratory activities and organizational needs.
Requirements
- A B.S. degree and at least 12 years of related experience, or an M.S. degree and at least 10 years of related experience, or a Ph.D. and at least 7 years of related experience in a scientific discipline.
Responsibilities
- Execute process development, process characterization, and technology transfer of microbial processes to the commercial cGMP facility.
- Develop broad knowledge of state-of-the-art principles and theory, provide technical leadership, and serve as an in-house advisor in key scientific disciplines as needed.
- Coach and develop departmental scientists and guide the professional growth of the team.
- Manage performance and ensure that teams meet expectations and objectives.
- Produce high-quality documentation and client reports suitable for publication and regulatory requirements.
- Support process development in laboratory and manufacturing areas and execute experiments with minimal oversight.
- Use process data to conceptualize and propose process development and manufacturing approaches.
- Act as a subject matter expert and direct team efforts toward project deliverables.
- Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with minimal oversight.
- Maintain a current understanding of cGMP and other regulatory requirements.
- Follow safety requirements and ensure departmental employees comply with required safety procedures.
- Maintain training compliance according to site expectations.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
