Scientific Protein Laboratories is a world leader in the development and manufacturing of naturally sourced biopharmaceuticals. SPL has recently embarked in a new direction of expanding and diversifying its product portfolio and pipeline by actively developing new technologies and products through both external partnerships and internal development efforts. We have an immediate opening in Waunakee, WI (Madison area) for a senior development scientist and/or up to program manager to join our Scientific Affairs Innovation team.
The candidate will work in conjunction with project teams to define scientific strategy and to support project needs throughout the product development lifecycle. The scientist will have a broad knowledge of regulatory, scientific, and technical issues concerning drug product applications in the USA, Europe and other markets. This role requires working with external partners including CROs and CMOs.
Responsibilities
- Author and review technical documents in support of regulatory submittals (e.g.MAA, NDA, ANDA and BLA) and preparation of submission ready sections in CTD format
- Oversight of CROs and CMOs as a technical expert and coordinate contract work to ensure projects adhere to established timelines and technical specifications
- Facilitate API and finished drug product (dosage form) development activities including biochemical and biophysical characterization, formulation development, and extractable/ leachable studies, etc.
- Prepare presentations, organize meetings, and collaborate with other scientists and departments
- Identify issues that may delay timely completion of critical project tasks and escalate as needed
- Work cross-functionally and communicate effectively across functional areas and collaborate across the organization to help identify/develop new external development capabilities
- Perform laboratory work as needed
- Perform other duties as assigned
