Vacancy expired!
Remote during covid then required to be on site
Must have experience in process development with GMP manufacturing, quality systems and writing regulated 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 within process development in cross-functional group projects as technical SME working with supplier quality management and supply chain.
Supplier Change Notifications - assessing impact of change to product and process
Raw material non-conformances – Root cause investigations, evaluation of SICAR Responses (CAPAs) and effectiveness verification of supplier CAPAs
Raw material early engagement - Technical SME for raw material sourcing required to establish new GMP raw materials and suppliers
Must have 5+ years of industry experience - open to industry, pharma or biotech preferred
If candidate is PhD, 2+ years of industry experience
Bachelors Degree Minimum
Top 3 Must Have Skill Sets:
Required Skills and Experience
Experience in process development with GMP manufacturing, quality systems and writing regulated documents
Excellent communication skills (written and oral) and ability to work in cross-functional teams
Excellent analytical/problem-solving skills and ability to work with technical documents and perform data analysis