Scientist/Sr. Scientist, Analytical Development

Our Vaccine client located in Woburn, MA is growing and looking to add a Scientist/Sr. Scientist to their Analytical Development team!. Role will execute Quality Control testing, and associated operations as well as develop analytical assays to support the current and future products. This is a unique opportunity to be part of an emerging early-phase clinical company bringing innovative technology to the global market.

Responsibilities:
? Contribute deep scientific know-how, design, development, and execution of immunology cell-based assays (e.g., ELISA) to assess immunogenicity
? Develop, qualify, validate, and characterize purity/potency methods for intermediates and drug products, including immuno-based potency assays, and process and product impurity assays.
? Writes and executes cGMP assay qualification/ validation protocols and reports, executes routine QC testing, trains QC and other scientists
? Provide SME support for investigations of deviations, invalid assays, and other non-conformance issues related to GMP manufacturing and QC testing
? Strong subject matter expertise in protein characterization techniques, including ELISA, HPLC, SEC, DLS, SDS-PAGE, UV-Vis, and potency assays
? Contribute to regulatory filing documents and independently author method SOPs, analytical protocols, and reports
? Effectively collaborate cross-functionally to facilitate the success of projects and meet organizational goals
? Consummate ability to work in a highly collaborative, fast-paced, cross-functional environment, with superior oral and written communication skills

Requirements:
? Ph.D. in immunology, cell biology, or related field of study with a minimum of 4 years in the biotech or pharmaceutical industry; OR BS/MS with 8+ years of relevant industry experience.
? Demonstrate in-depth expertise in immunology with extensive hands-on experience designing, troubleshooting, and implementing immuno-based assays.
? Experience in independently planning, developing, troubleshooting, and executing immuno-based functional assays such as ELISA to quantify immune responses.
? Hands-on experience with several of the following techniques: ELISA, HPLC, SEC, DLS, SDS-PAGE, Western blot, and immuno-based functional assays
? Experience working in a QC/GMP laboratory is a plus