Responsibilities of the Formulation Manager:
- Development of formulations and processes for new and existing products.
- Preparation of development reports and other technical documentation to support the IND and NDA processes.
- Preparation of protocol documentation for the manufacture of development and clinical batches.
- Process Design and Technology transfer activities, including equipment design, process scale up, and development of batch records and other documentation.
- Establishes equipment and process parameters that may impact the quality of drug products.
- Involved in the procurement of equipment and supplies required for clinical and FDA exhibit lots.
- Ensures cGMP requirements are met as they relate to development of new products and the manufacture of clinical and submission materials.
Requirements of the Formulation Manager:
- BS or MS in ChemE or related area and 3+ years relevant supervisory experience in an FDA regulated industry.
- Must have experience with with Product Formulation, Clinical Manufacturing, or Process Engineering.
- Exceptional technical writing, review and analytical skills.
- Knowledge of good documentation practices and cGMPs.
Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.