A BS, or MS degree in Pharmaceutics, Biochemistry, Chemistry, Chemical Engineering, or related scientific discipline, with up to 1 year of protein formulation and/or manufacturing process development experience
•Experience with bioanalytical and/or biophysical assessment techniques for product characterization and product stability evaluation, such as HPLC, SDS-PAGE, SEC, Spectroscopy (UV/VIS, fluorescence, light scattering, &/or CD), DSC, particulates detection & quantitation methods.
•Understanding of the regulatory submissions processes that may include authoring, contributing to, and critical review of successful regulatory submissions
Creativity & innovativeness; a highly motivated self-starter with drive to succeed
Strong verbal and written communication skills and capabilities
Ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques
Ability to work effectively as an individual contributor, and as a team member within team and matrix environments.
Strong interpersonal skills and behaviors.
Understanding of actives, raw materials and their function and how they are brought together to form a stable, functioning product from prototype evaluation to commercial launch
Contributes to development of the company's products.
You will be part of a Product Development Team within the Biopharmaceutical
Product Sciences department and will work on developing drug products and manufacturing processes for protein & peptide-based therapeutics. Specific responsibilities will be focused around laboratory experimentation, manufacturing development and analytical testing of formulations & manufacturing approaches for select protein therapeutics. This includes contributing to designing & evaluating standard & novel product matrices; physicochemical and bioanalytical characterization of native and modified biopharm compounds; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations, and interfacing with other groups to craft GMP stability protocols and assess resultant data; working closely with regulatory affairs partners in crafting, reviewing, and submitting regulatory documentation to support clinical progression; working closely with internal & external discovery and development support partners, as needed; maintaining accurate, complete laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques.
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