Qc Analytical, Scientist I
By Astellas At , Westborough, Ma
Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211).
Oversee and execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and assay troubleshooting.
Author, revise and review SOPs, qualification/validation protocols and reports.
Strong knowledge of GMP, SOP’s and quality control process
Strong written and verbal communication skills.
Experience in the biotech and/or pharmaceutical industry.
Sr. Staff Scientist - Plasmid Manufacturing (Remote)
By Thermo Fisher Scientific At , , Fl
Assist with completing Request for Information (RFIs) and Request for Proposals (RFPs) and ensure timely delivery and customer requirements.
Bachelor’s degree in biological sciences or related field with minimum 8 years of relevant experience
Advanced degree in biological sciences or related field with 5+ years of relevant experience
Knowledge on cGMP manufacture preferred.
Customer-facing experience in previous positions preferred.
Serve as a subject matter authority (SME) supporting Sales and Business Development Executives (BDE) for plasmid manufacturing projects.