A BS, or MS degree in Pharmaceutics, Biochemistry, Chemistry, Chemical Engineering, or related scientific discipline, with up 1 year of protein formulation, drug delivery, and manufacturing process development experience
•Experience with biopharmaceutical protein formulation, manufacturing, and drug delivery/device development, including the application of DOE
•Experience with multiple bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation, including HPLC, SDS-PAGE, SEC, Spectroscopy (UV/VIS, fluorescence, light scattering, &/or CD), DSC, particulates detection & quantitation methods.
•Understanding of the regulatory submissions processes, including 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 . Participates in international product teams to define and implement development policy and programs that best support the product strategy and future positioning of the organisation.
Designs and executes studies to discover, understand, model, simulate, and create new drug molecules. Researches target identification, target validation, drug interactions with targets or receptors, and assay development. Maintains knowledge of competitive market conditions, patient requirements and technology advances
You will be part of a Product Development Team within the Biopharmaceutical
Product Sciences department and will work on developing drug products, delivery systems, and manufacturing processes for protein & peptide-based therapeutics. Specific responsibilities will be focused around laboratory experimentation and analytical testing of putative formulations & drug delivery approaches for select protein therapeutics, which includes contributing to conceiving & evaluating standard & novel product matrices and administration modalities; 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 key 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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