myGwork - LGBTQ+ Business Community · 2 days ago

Process Development Engineering Senior Scientist

Boston, MA

Full-time

Onsite

Senior Level

8+ years exp

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Responsibilities

Design and execute experimentation to develop robust manufacturing processes for cell therapy products and implementation to support programs in clinical development.

Lead and train a team of bioprocess engineers who will work closely together within a highly matrixed, cross-functional team to deliver program goals.

Manage and/or execute pluripotent stem cell culture and differentiation to support process development, optimization, and characterization.

Manage troubleshooting with high degree of complexity.

Document experimental procedures and results according to established guidelines. Perform statistical analysis of experimental data to determine critical process parameter ranges.

Communicate progress versus plan, identifying and escalating business-critical issues affecting supply and timelines as necessary, providing recommendations, mitigations, and potential solutions.

Collaborate effectively within departmental teams, contribute to deliverables and drive development activities in a cross-functional environment, engage on team discussions to resolve issues, and lead projects with a fully integrated team to facilitate successful outcomes.

Serve as an internal technical subject matter expert and support technology transfers.

Coordinate resources and set priorities for own team, contributing to the overall goals of the department.

Generate and review technical reports, regulatory filings, source documents, patents and external publications, as applicable.

Qualification

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Cell Culture ProcessesDesign of ExperimentsStatistical AnalysisGMP RequirementsBioreactorsCell Processing DevicesExperimental DesignManufacturing ProcessesLeadershipProblem-SolvingCommunicationAdaptabilityOrganizational Skills

Required

BS in Biochemistry, Engineering, Biology or related discipline with 8+ years of industry experience; or an MS with 5+ years of industry experience; or a PhD with 2-5 years of industry experience.

Willingness to effectively lead a team of scientists/engineers, minimum of 1 year of direct management experience.

Experience independently conducting and directing the design, execution, analysis, and documentation of cell culture processes for biologics and/or cell therapy products.

Experience in evaluating and introducing novel technology platforms into process development and manufacturing.

Experience in design of experiments (DOE) and statistical analysis.

Experience working with cell processing devices and bioreactors.

Working knowledge of GMP requirements.

Excellent verbal and written communication skills and ability to handle multiple tasks while meeting timelines and adapting to changing priorities.

Strong organizational skills and high attention to details.

Periodic weekend rotational work to support cell culture activities will be required.