Vacancy has expired
Show me jobs like this one| Job Ref: | DP Formulation |
| Job Type: | Full Time |
| State: | California (CA) |
| City: | Hayward |
| Post Code: | Aug 16, 2011 |
| Job Description: |
PRIMARY FUNCTION: The Director of Drug Product Formulation Development will be responsible for identifying and developing suitable Drug Product formulations and manufacturing processes for Antheras product portfolio compounds. Responsibilities will include all formulation and Drug Product process development activities necessary for clinical, commercial, and line extension products. The selected individual will have a proven track record in applying fundamental scientific and engineering principles toward formulation and drug product process development. To be selected, this individual will have significant experience in the scale-up of drug product processes, ensuring that manufacturing processes are sufficiently robust for successful process validation. This candidate should be familiar with cGMP, as well as CMC requirements for regulatory filings in the USA and Europe. Strong organizational skills allowing for oversight of CROs/CMOs. MAJOR DUTIES AND RESPONSIBILITIES: 1. Oversee the development and optimization of formulation composition, scale-up and characterization of manufacturing process, evaluation of new drug delivery technologies, outsourced formulation activities, identification and characterization of excipients, preparation and review of regulatory documents. 2. Ensure that all development and manufacturing activities are carried out in a manner consistent with regulatory requirements. 3. Collaborating with key stakeholders within project team, to ensure efficient and productive cooperation with other departments. 4. Regular review of technical progress on experiments to ensure optimal development and sound decision making. Requirements - Ph.D. in Pharmaceutical Sciences, Biochemistry or equivalent with more than 5 years of industrial experience in formulation development, good understanding of cGMPs and expertise in drug product development and manufacturing including regulatory and clinical requirements. |
| Post Date: | 08/17/2011 |
