KBI: US - Process Development Scientist II
About The Position
The PD Scientist II provides process development ownership for a product, including all development and design decisions, with some oversight and supervision. They can apply advanced scientific principles to design and execute laboratory studies for unit operation development and optimization and solve problems of increasing scope and complexity. They possess a strong working knowledge of one or more facets of functional area with a developing understanding of phase-appropriate practices and expectations. They author and review technical documents including protocols and reports commensurate with PD compliance and quality standards. This workflow encompasses process development scope as well as support of technology transfer activities in preparation for cGMP production. Additionally, the PD Scientist II may mentor and train junior staff within the process development group including co-ownership of programs as needed. Technical expertise is developing in one or more areas of the job function and may be called upon to support troubleshooting or other activities beyond an individual program scope. The PD Scientist II is responsible for maintaining training compliance, according to site expectations. This is a salaried exempt position, with the expectation to cover shift work as needed to support laboratory activities and organizational need.
Requirements
- B.S. degree and a minimum of 6+ years of related experience; M.S. and 4+ years of related experience or Ph.D. and 1+ years related experience in a scientific discipline.
Responsibilities
- Executes process development, process characterization, and technology transfer of microbial upstream/downstream processes to commercial cGMP facility.
- Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
- Supports process development efforts in the laboratory and manufacturing areas.
- Executes experiments with some oversight.
- Conceptualizes and proposes process development and manufacturing based on process data.
- Works toward developing a broad knowledge of state-of-the-art principles and theory; provides some technical leadership within the group.
- Will lead the upstream portion of development, process characterization, and/or technology transfer programs, acting as subject matter expert, and directing the efforts of the team in meeting the project deliverables.
- Provide technical support for cGMP manufacturing through floor coverage, batch document review, and support of deviations and change controls with some oversight.
- Coach and develop departmental scientists.
- Assist in guiding the professional growth of team.
- Responsible for developing/maintaining a current understanding of cGMP and other regulatory requirements.
- Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
- Able to react to change productively and handle other essential tasks as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
