Scientific Protein Laboratories is a biopharmaceutical leader in the development and manufacturing of cGMP-compliant products including pancreatic enzymes and heparin. Lately, SPL has embarked in a new direction of expanding and diversifying its product portfolio and pipeline by actively investing in new technologies and products including both external partnership and internal development effort. We have an immediate opening in Waunakee, WI (Madison area) for a Sr. Development Scientist to join our R&D's new drug development team.
The Sr. Development Scientist will work independently and in conjunction with appropriate teams to define scientific strategy and to support R&D program/project needs throughout product development process. The candidate will also independently lead, design and perform development and characterization in support of large molecules of various nature (e.g. proteins, polysaccharides and nucleic acids, etc.). This role requires internal cross functional alignment as well as ability to manage and work with external partners. This position will report directly to the VP of R&D.
Lead drug development process including characterization studies relevant to the stage of development. Studies include, but are not limited to, biological and biophysical characterization and studies spanning entire development process including functional characterization, animal models, toxicology and PK/PD, formulation development, and management of CRO and CMO.
Lead, facilitate, and participate in technical discussions to successfully resolve problems with all stakeholders, methods, project issues and deviations
Author and review documents for regulatory filings (IND, NDA and BLA, and their foreign equivalent) and internal company use.
Deliver an improved focus on the scientific rigor within the R&D Department, ensuring consistent scientific excellence and scientific quality standards are met.
Help define strategy per program/project/technology timelines
Assist with CDMO product development as required.
A PhD in Biology, Chemistry, Microbiology or related field is required.
Minimum 2 years relevant experience required. 5+ years preferred.
Hands on industrial experience in biotech/pharma with experience in drug development, drug product formulation and drug delivery.
Demonstrated competency and experience in biologic drug product development within the pharmaceutical industry with a high level of technical understanding is required
Effective communication skills and demonstrated leadership in providing integration of activities and delivering information across multifunctional groups and sites is required
The candidate should be able to use emerging developments in relevant scientific fields to generate new research ideas and initiatives
Demonstrated experience in scale-up of manufacturing processes and technical transfer of projects into commercial manufacturing is preferred
Drug product development experience that spans early through late phase including biologics CMC and manufacturing process is preferred
Some understanding and experience with biosimilar product development and regulatory process, e.g., 351 (k), will be very helpful
Experience with authoring and reviewing regulatory filings is preferred
Experience in drug delivery technology, genomics and NGS, cell therapy including stem cell product development is preferred
SPL offers a competitive salary, a comprehensive benefits package and a pleasant work environment.