Top 3 Must Have Skill Sets:
- Experience in process development working in cross-functional teams
- Excellent analytical/problem-solving skills and perform data analysis
- Experience with quality systems and writing technical documents
This position is for a Scientist in the Materials Science group working under the guidance of the hiring manager. The Scientist will support a range of cross-functional activities to support media, chemical and excipient raw materials used for synthetic and biologic processing.
Core job responsibilities include:
- Representing the Materials Science function as a technical SME within process development in cross-functional teams with supplier quality management and supply chain.
- Supplier Change Notifications - assessing impact of supplier changes to the raw material attributes and subsequent impact to our processes and product
- Raw material non-conformances – Root cause investigations, evaluation of supplier SICAR responses and CAPAs
- Raw material early engagement - Establish target attribute profiles of GMP raw materials to facilitate supplier selection and specification development
BS/BA or Masters in engineering or chemistry and at least 2 years of experience working in the biotechnology/pharmaceutical industry
Required Skills and Experience
"This posting is for Contingent Worker, not an FTE"
- Experience with quality systems and writing regulated documents
- Experience in process development preferred
- Excellent communication skills (written and oral)
- Ability to work in cross-functional teams
- Good organizational skills
- Excellent analytical/problem-solving skills
- Be able to multi-task and function in a dynamic environment
- Ability to work with technical documents and perform data analysis