Kashiv Pharma, LLC.
Piscataway, NJ, United States
Biotech, Sciences, Chemistry
Kashiv BioSciences A fully-integrated biosciences company with an expanded and dynamic platform for growth including advanced drug delivery technologies, biosimilars, prodrugs, and a large development pipeline. We are looking for an experienced Upstream Bioprocess Development Lead to join our Piscataway, NJ process development team. Please visit http://kashivbiosciences.com/ for more information about Kashiv BioSciences.
The Upstream Bioprocess Development Lead is a hands-on position responsible for running the daily operation of Kashiv\u2019s cell line development and upstream process development functions. The lead is responsible for developing robust mammalian cell culture processes, producing a wide range of mammalian based biosimilar proteins, and generating stable, high producing cell lines. This position requires technical expertise in cell culture processes, bioreactor operations and cell biology. It also requires working knowledge of cell line development.
Essential Duties and Responsibilities
Provide functional leadership and subject matter expertise to establish phase-appropriate cell culture based recombinant protein production processes at multiple scales
Design and implement rigorous product-development strategies utilizing DoE (Design of Experiment) and other process-design elements aligned with a QbD (Quality by Design) approach
Lead process transfer, scale-up, and process characterization activities
Provide hands on and strategic leadership to a team of scientists and engineers to support company goals and activities
Oversee development of mammalian cell lines for recombinant protein production
Develop and maintain productive relationships with internal and external collaborators and partners
Industry based stable cell line development experience
Demonstrated ability to function effectively across a matrix organization
Outstanding organizational and communication skills (especially technical writing, verbal and presentation), and excellent supervisory skills
Knowledge of current GMPs, and FDA and / or European validation practices for biopharmaceutical processes
This position will be based in Piscataway, NJ and will require occasional travel to support the global product pipeline.
EducationBachelor\u2019s, Master\u2019s degree, or Doctoral degree in chemical, biological, or biochemical sciences with experience in commercial biotech At least 10 years industry based cell culture process development or upstream process characterization experience including recent experience completing CHO based cell culture / monoclonal antibody development projects
Kashiv Pharma, LLC.
Website : http://www.kashivpharma.com