Assoc. Scientist, Engineering- Cell Culture and Fermentation Sciences

Job Description

As part of our Company Manufacturing Division, within the Bioprocess Drug Substance Commercialization (BDSC), the Cell Culture and Fermentation Sciences (CCFS) department provides the technical process leadership and laboratory capabilities in support of late-stage pipeline and post-market (in-line) commercial manufacturing processes for vaccines and biologics. CCFS supports various commercialization activities including second generation process development, process characterization, technology transfer to internal and/or external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.

Under the general scientific, technical, and administrative direction of a CCFS Group Leader in West Point, we seek a motivated scientist/engineer to support development and licensure of novel vaccine candidates and in-line products.  Working in conjunction with internal and external partners, this colleague will sponsor late-stage bulk process development, characterization, technology transfer, clinical manufacturing, and validation studies associated with the development and implementation of bulk processes, systems and facilities related to therapeutic proteins & vaccines.  The person will demonstrate scientific, experimental and tech transfer skills focused on fermentation and/or cell culture processes.

In this role, you will be responsible for:

• Functioning as a key member of the process development team through executing lab scale process development, in-process assay support, and process scale-up or scale-down of cell culture/fermentation (upstream) process unit operations.

• Executing the hands-on execution of lab-scale experiments and authoring associated technical reports and documents.

• Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing.

• Leading assignment execution against accelerated, critical-path timelines in a right first-time-manner.

• Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure.

• This role may require working outside of core business hours to support lab studies and/or on-site activities related to tech transfer and manufacturing.

Education:

• B.S. or M.S. in Chemical Engineering, Chemistry, Biology or comparable discipline.

Required Knowledge and Skills:

• Upstream process development and manufacturing sciences knowledge

• Ability to work independently and as part of a team to execute against key commitments.

• Candidates should have excellent interpersonal and communication skills that enable effective management and resolution of complex, project-related issues involving collaborations with multiple functional areas.

• Expertise in lab-scale experimental execution, statistical data analysis, presentation of results/conclusions, and the application of principles/theory into process design and practice.

Preferred Experience and Skills:

• Experience with upstream lab or pilot-scale fermentation or cell culture processes.

• High throughput fermentation or cell culture experience.

• Experience authoring technical documentation to support regulatory submissions.

• Experience with large molecule commercialization (facility start-up, technology transfer).

• Experience within pilot-scale, or manufacturing environment.

• Large molecule drug substance process development, scaling (up and down) and tech transfer.

• Current Good Manufacturing Practice (cGMP) experience.

• Analytical method execution or development.

• Experience with instrument maintenance and troubleshooting.

• Experience with the following software: JMP, Spotfire, PI Process Book, or similar; experience with Design of Experiments (DOE).

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US and Puerto Rico Residents Only:

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