Senior Process Development Scientist - Upstream Manufacturing job in Cranbury, USA

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Job type: Permanent

Discipline: Biochemistry, Biological Sciences, Laboratory Technician

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Senior Process Development Scientist - Upstream Manufacturing with a pharmaceutical company located in Cranbury, NJ.

Job Responsibilities:

Lead process development, process characterization and scale-up activities to enable high productivity, scalable and robust upstream processes for viral vector manufacturing.
Serve as a subject-matter-expert for the upstream process development of viral vectors using stir-tank bioreactor technologies (e.g., Ambr250, glass vessel, rocker-bag, single-use bioreactors up to 2KL scale).
Lead laboratory-scale studies for commercial process development, process characterization, and GMP manufacturing deviation/trend investigations activities to deliver end-to-end work-packages (e.g., process description, control strategy, facility fit assessment).
Design and execute laboratory studies to evaluate novel technologies to improve existing processes and establish manufacturing platforms.
Lead scale-down model establishment and qualification activities to enable process characterization and manufacturing investigations.
Support authoring of regulatory (e.g., IND, CTD process sections) and process development documentation.
Lead protocol and technical report authoring, participate in cross-functional team discussion, and present study outcomes to stakeholders.
Interact with external CMO/CDMOs, vendors, and partners and assist in technology transfer.
Collaborate effectively with process development and analytical development teams

Skills and Requirements:

PhD/MS in chemical engineering, biochemical engineering, bioengineering, biochemistry, biological sciences, or relevant field of study
PhD with 0 - 3 years or MS with 5+ years of hands-on experience in process development, MS&T, or manufacturing in Biotech/biopharmaceutical industry. Experience with gene therapy a plus.
Sound fundamentals and/or hands-on experience of upstream cell culture processes (e.g., fed-batch, perfusion) and stir-tank bioreactor technologies (e.g., Ambr250, glass vessel, rocker-bag, single-use bioreactors up to 2KL scale) to manufacture biologics or viral vectors or vaccines. Prior experience with viral vector upstream process development is strongly preferred.
Experience with high-throughput upstream process development (e.g., Ambr system) is desirable.
Experience with scale-down model qualification and scaling-up suspension cell culture stirred tank bioreactor processes to ≥ 200L is desirable.
Proven track-record of process development and/or process characterization and/or process performance qualification and validation is desirable.
Excellent communication and presentation skills, capable of conveying complex technical information in a clear, thorough, and influential manner is required.
Eager to work with highly skilled and dynamic teams in a fast-paced, entrepreneurial, and technical environment.
Motivated to evaluate novel technologies and develop template and process platforms to support organization growth.
Excellent MS Office skills with a specific focus on word, excel and power point applications to author technical reports and presentations.
Experience with statistical analysis tools (e.g., JMP, Minitab) is required.

If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at 267-428-7770. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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