The position is responsible for proposing, screening, evaluating and implementing product and technology development projects. It is also the responsibility of this position to lead, direct, and prioritize projects assigned to this position and associated Formulation staff.
DUTIES AND RESPONSIBILITIES
The primary duties and responsibilities of this position include the following:
- Lead in the development of new drug delivery technologies and products.
- Keep current with regulations and technical knowledge.
- Secure and provide adequate scientific formulation support to all assigned projects.
- Interface with internal and external clients in project meetings.
- Assist Business Development in preparation of R&D project proposals. Provide input on the technical feasibility and resources required of the project.
- Provide cost and man-hour estimates associated with R&D project proposals.
- Direct priorities for within the position.
- Provide input on project planning.
- Ensure all activities comply with OSHA, EPA, DEA and cGMP’s regulations.
- Maintain detailed records of all work to ensure compliance of all product submissions to the requirements by government agencies.
- Prepare and review CMC text for NDA/ANDA/DMF and other regulatory filings.
- Prepare and review master batch records, development pharmaceutics reports and other formulation documents.
- Provide necessary training and mentoring to junior Formulation staff.
- Participate in the interview and hiring of quality individuals to fill needed roles.
- Perform other tasks as requested by the Senior Director of Research and Development
- Minimum of a PhD Degree in Pharmaceutical Sciences or a related field with 6-10 years experience in the pharmaceutical industry.
- Solid background in pharmaceutics, biopharmaceutics or processing technologies in order to be able to invent, innovate and implement new ideas.
- Broad knowledge and extensive experience in drug product development projects in various phases to facilitate efficient and successful implementation of projects.
- Experience and training in supervision.
Location: Upper Midwest