Process Development Scientist

Position: Process Development Scientist

We are seeking a highly motivated and creative individual to be a part of a cutting-edge cell and gene therapy process and product development team. The successful candidate will be responsible for leading upstream PROCESS DEVELOPMENT/optimization studies to advance our R&PD programs from pre-clinical to IND filing and ultimately to BLA filing and commercial launch. The candidate will also be responsible for leading upstream technology transfer activities to our internal manufacturing site and CMOs.

Responsibilities:

• Lead upstream mammalian cell culture PROCESS DEVELOPMENT activities ranging from vial thaw, inoculum, cell culture development, and benchtop bioreactor/stainless steel bioreactor operations.
• Champion and progress select therapeutic candidates from early-stage Phase I to late-stage Phase II and Phase III clinical trials to commercialization.
• Lead technology transfer processes and work cross-functionally between Process Development and Manufacturing departments.
• Work cross-functionally with Downstream Process Development, Analytical Development, Manufacturing, Regulatory, and Quality departments for upstream related process improvement, process validation, process change control, deviation investigation, and process characterization activities.
• Manage laboratory experiments including scale-down studies, validation studies, process range studies, process robustness studies, and manufacturing troubleshooting activities.
• Lead upstream CMC development activities and contribute to IND regulatory submissions.
• Performing such other duties as may be assigned to you from time to time

Requirements:

• Ph.D. or MS in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field.
• 5+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
• Hands-on expertise in engineering and operating shake flasks, small-scale bioreactors, bench-top bioreactors including ambr, pilot scale reactors and stainless-steel bioreactors used for mammalian cell culture processes.
• Collaborate with cross-functional teams to optimize upstream bioprocess parameters, such as pH, temperature, agitation, and aeration to maximize yield, productivity, and product quality to support exosome production.
• Proficiency in data analysis and interpretation using software tools such as DOE, JMP to support process optimization.
• Ability to work independently with minimal supervision and adapt to changing priorities in a fast-paced environment.
• Strong Scientific and Engineering expertise developing novel upstream mammalian cell culture processes for biologic therapeutics (experience with cell therapeutic products and virus-like particles is preferred)
• Experience leading upstream process transfer activities with CMOs.
• Experience with GMP regulatory guidelines as related to the development of cell and gene therapy manufacturing processes is preferable.

Work Environment / Physical Demands:

• Laboratory environment working with chemical reagents and analytical equipment.
• Personal Protective Equipment must be worn as required.
• Must be able to lift up to 20 lbs.
• Must be able to stand/walk to work in a lab environment for extended periods.
• Must be able to sit for extended periods to use the computer.