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Senior Scientist of Process Development, Gene Therapy

GenScript

This is a Contract position in South Brunswick, NJ posted March 25, 2020.

The position reports to the Manager/Director of Process Development, is ideally suited for a dynamic bench-focused individual to lead translation of research process to GMP-compliant manufacturing, and will develop, scale-up and oversee the tech transfer of viral vector processes.

This is a great opportunity to join a fast-paced company, and have the technical chops to lead by example and potentially lead a small team in the near future.

1.

Hands-on experimental work in the development and optimization of upstream (cell culture and transfection conditions) and downstream (clarification, tangential flow filtration, chromatography) unit operations for viral vector manufacturing process.

2.

Interact with manufacturing and QA groups to problem-solving and troubleshooting exist process designs, and technologies, using scale-down models.

3.

Contribute to the planning and design of experiments, execution and independent analysis of data.

4.

Support process transfer, and analytical method development activities.

5.

Maintain and follow detailed and comprehensive project timelines.

6.

Involve in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.

7.

Present updates to project or upper management teams on process development and manufacturing support activities.

8.

Read and understand scientific literature in gene and cell therapy, use the knowledge to generate ideas and contribute to process design and development.

9.

Perform other duties as assigned based on business needs.

Qualifications 1.

Bachelor’s degree with 3-5 years, or Master’s or Ph.D.

degree with 0-3 years’ experience in Molecular Biology, Analytical Chemistry, Immunology, Chemical Engineering or equivalent in biotech development with particular experience in gene and cell therapy product design.

Experience with Lenti, AAV process development for oncology, gene modified T cell products a plus.

2.

Previous experience in viral vector process development and manufacturing is preferred.

3.

Strong understanding of process scale-up and scale-down modeling.

4.

Good understanding of Design of Experiment and statistical analysis.

5.

Experience in CMC regulatory affairs for FDA, and EMA is a plus.

6.

Strong interpersonal, verbal, and written communication skills.