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.
 

Manager, Biopharmaceutical Development


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.  

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