Sr. Technology Transfer Cell Culture Scientist

Technology Transfer Upstream Cell Culture/Fermentation Scientist - East Coast

You will be responsible for providing Scientific leadership and project management for multiple upstream mammalian cell culture technology transfer processes for the generation of monoclonal antibody and recombinant protein therapeutic products.

You will be directly responsible for managing technology transfer activities for cGMP upstream mammalian cell culture & microbial fermentation manufacturing activities ranging from inoculum, bioreactor/fermentor optimization, and scale-up. You will also be responsible for running mammalian cell culture & microbial fermentation scale-down studies, process validation activities, and process characterization activities of recombinant protein products. Technology transfer activities involve managing incoming biologic processes and supporting transfer out to on-site and 3rd party Contract Manufacturing Organizations (CMO). This is a critical position where you will be directly involved in developing and supporting processes for late stage Phase III clinical trial materials. Other responsibilities include the design of experiments (DOE) and documentation in accordance to cGMP compliance.

Preferred Candidate Background and Expertise:

* Ph.D. in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field.
* Over 5 years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
* Experience managing technology transfer activities with Contract Manufacturers (CMOs) and off site locations.
* Strong Scientific, Engineering, and Manufacturing troubleshooting expertise involving mammalian cell culture & microbial fermentation processes for the generation of monoclonal antibody and recombinant protein therapeutic products.
* Hands-on expertise engineering and operating upstream mammalian cell culture & microbial fermentation equipment including seed banks, fermentors, and bioreactors.
* Expertise leading scale-up, technology transfer and process validation (PQ) activities.
* Expertise working within cGMP compliance and providing GMP documentation.