|Date Posted||January 21, 2021|
|Address||PO Box 158|
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 Analytical team.
This position is responsible for independently performing product, process and assay development for internal projects or client projects. The Analytical Scientist performs lab and pilot scale production and/or method validation. This position also provides support to Production, Quality Control, and Marketing Departments concerning technical matters.
- Develop assays for existing as well as new products; Design, execute and interpret experiments/investigations in support of new and existing products.
- Perform testing for contract development and manufacturing projects; Perform method development, method transfer and method validation.
- Prepare study reports, write Standard Operating Procedures (SOPs) and prepare other documentation as required by FDA regulations.
- Provide technical support to Quality Control, Production and Marketing and write clear and concise reports for projects performed for these departments.
- Advanced degree required (e.g. PhD in Biology, Chemistry, Microbiology, and related sciences)
- Two or more years of laboratory related experience
- Industrial experience, especially in a pharmaceutical setting with understanding of CMC strategies is highly desirable.
- A strong working knowledge of protein chemistry, oligonucleotides, and one or more analytical techniques (ELISA, CE-MS, SDS-PAGE, HPLC, LC-MS/MS, NMR) is necessary
- Excellent interpersonal skills and strong verbal and written communication skills
- Good organizational skills are essential as is the ability to work independently and meet project deadlines