Director Upstream Cell Culture & Fermentation Process Development
Laguna Source - San Diego, CA

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This
is an exciting leadership position responsible for
overseeing all drug substance development including upstream mammalian cell
culture and microbial fermentation operations. You will be responsible for managing teams comprised of Process Development and Manufacturing professionals. You will be charged with overseeing the following

activities:
  • Providing Scientific and technical team leadership
of all mammalian cell culture process development and e.Coli microbial fermentation operations for the
generation of monoclonal antibody and recombinant protein therapeutic
products.
  • Leading all upstream mammalian cell culture process
development and manufacturing operations ranging from vial thaw, inoculum, media
development, media optimization, cell line development, and stainless
steel bioreactor operations.
*
Driving and progressing select therapeutic candidates from Phase I,
Phase II, and Phase III clinical trials into commercialization.
  • Leading upstream related technical troubleshooting including deviation handling and investigations.
  • Leading BLA filings and CMC submissions.
Preferred Candidate Background and Expertise:
  • MS or Ph.D. in Biochemical Engineering, Chemical Engineering or related Scientific/Engineering field.
  • 10+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.
*
Strong Scientific and Engineering expertise leading upstream mammalian
cell culture process development for the
generation of monoclonal antibody and
recombinant protein therapeutic products.
  • Hands-on expertise
engineering and operating mammalian cell culture and e.Coli fermentation processesing equipment
(fermentors and stainless steel bioreactors).
  • Strong experience managing relationships with external contract manufacturers and managing technology transfer processes.
  • Experience contributing to BLA/CMC filings, and hosting FDA/EMEA audits & inspections.
  • Knowledge and expertise in process modeling, Quality by Design (QbD) and Design of Experiments (DOE).
  • Expertise working within cGMP compliance and providing GMP documentation.

About this company
Laguna Source is a national search firm specializing in full time permanent placement. Our areas of expertise include biopharmaceutical,...