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.
- 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.
- 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