The ideal candidate will have an MS degree, or a BS degree with ≥5 years of laboratory experience, in Pharmaceutics, Biology, Biochemistry, Chemistry, Chemical Engineering, or related scientific discipline
Experience with both conventional and alternative 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, etc.
Understanding of the regulatory submissions processes, including authoring, contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions and BLA/MAA filing experience.
Experience in working with in vivo/ in vitro models to critically assess formulation & delivery modalities.
Ability to work effectively as an individual contributor, and as a team member within team and matrix environments.
Strong interpersonal skills and behaviors.
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.
You will be part of a Product Development Team within the Biopharmaceutical Technologies department of the Biopharm R&D Unit, and will work on developing drug product, 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; working with the Bioanalytical Sciences group to develop & transfer stability-indicating analytical methods for use in product development; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations, and interfacing with the Quality Control & Compliance group 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;
Use of electronic data & information gathering, capture, archiving and communications techniques; and, assisting in preparation and review of manufacturing batch records, SOPs, and other supporting documentation, as appropriate. You must be a creative, innovative self-starter, with excellent verbal and written communication skills, and the ability to work effectively individually, as well as, in team and matrix environments.
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