The Contractor, Viral Vector Technology Development - Gene Therapy actively contributes to the execution of upstream process development activities for gene therapy vector production. This includes, but may not be limited to, cell and virus culture development and Design Of Experiment execution.
This individual executes small scale studies to support upstream development work and interacts extensively with downstream Process Development, Analytical Development and Manufacturing personnel to deliver high-quality and robust upstream processes in a regulated environment.
location: Pennington, New Jersey
job type: Contract
salary: $50 - 55 per hour
work hours: 9 to 5
- Actively contributes to VVTD process development activities for both internal and external projects.
- Assists with on-going VVTD process development and execution activities at external vendors as appropriate.
- Applies experience with small scale bioprocessing equipment and its application to gene therapy process development and GMP manufacturing.
- Works closely with upstream to transfer VVTD processes to scale up, as appropriate.
- Executes small-scale shake flask, 2-D multilayer flask and small-scale bioreactor studies to support the development of cell, virus and plasmid DNA-based gene therapy upstream manufacturing processes.
- Supports writes reports as required.
- May collaborate with Analytical Development to support upstream process understanding and design space via design and execution of in-process testing and control assays.
- Actively contributes to, and assures the effective execution of, science-driven, phase-appropriate, and risk-based process development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
- May provide support for activities associated with writing and/or QC reviewing of relevant sections of global regulatory filings. These include, but may not be limited to, INDs, BLAs and ex-US filings
- A Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant scientific discipline and a minimum of 1 year of progressively responsible experience in biologics and/or gene therapy process development roles OR a Bachelor's degree in these same disciplines and a minimum of 3 years of relevant experience.
- Working knowledge of mammalian cell culture, cell cloning, virology, and upstream processes is required.
- Experience designing and executing experiments evaluating new technologies including but not limited to: new bioprocessing equipment, novel transfection or electroporation technologies, cell cloning, cell intensification and, and media development
- Good level understanding with virology concepts, viral manipulation, and viral characterization.
- Demonstrated understanding of, and applied experience with, cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, nucleic acid and protein sequencing.
- Proficiency with Microsoft Office.
- Excellent verbal and written communication skills.
- Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
- Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Experience with HEK293, BHK, Hela, and/or Sf9 culture preferred. Experience with herpesvirus- or adenovirus-based AAV production methods preferred.
- Experience with relevant molecular biology techniques preferred, such as DNA plasmid cloning, transformation, microbial cultures, and plasmid purification.
- Small company and/or start-up experience.
skills: Cell Biology, Cell Cultures
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.