Manager, Biopharmaceutical Development

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Manager, Biopharmaceutical Development to work for a leading Orange County Area pharmaceutical company.

 

Responsibilities:

 

  • Perform within cGMP regulations, and FDA and ICH guidelines.
  • Supervise, train, and assign training for a group of chemists, scientists, and/or technicians.
  • Provide scientific leadership in analytical sciences.
  • Collaborate with other departments to contribute to departmental and company development strategies.
  • Work closely with PMT (Project Management Team) to address client demands.
  • Organize, coordinate, execute, interpret, and present project assignments and results internally and externally.
  • Write protocols, scientific reports, and other technical documents, and participate in the interpretation of data, collaborating with other departments.
  • Troubleshoot instrumentation when needed.
  • Contribute significantly to overall corporate goals.
  • Performs other duties as assigned.

 

Requirements:

 

  • BS/BA in Biology, Chemistry, Biochemistry, or related field
  • Must have 10+ years of experience in contract testing industry
  • Extensive hands-on knowledge of Biopharmaceutical Development, HPLC and/or UPLC experience analyzing large molecules such as proteins (e.g. antibodies, enzymes, insulin), lipids and or nucleic acids.
  • Knowledge of Protein and Peptide chemistry and practical experience in Biopharmaceutical testing (ELISA, Gel Electrophoresis, Peptide Mapping, Amino Acid Analysis).
  • Experience with Biopharmaceutical analysis, analytical method development and validation for proteins and peptides, as well as dosage form design, including lyophilized and non-lyophilized injectable dosage forms, and capsule and tablet dosage form is preferred.
  • Strong comprehension of USP, EP and other compendial methods and procedures.
  • Managerial experience is required
    • Strong ability to take projects from conception to execution
    • Strong managerial skills and ability to manage all stages
  • Location: Orange County
  • Type: Permanent
  • Job ID: GL6516591130