The ideal candidate will have a BS (or MS) degree in Pharmaceutics, Biology, Biochemistry, Chemistry, Chemical Engineering, or related scientific discipline with ≥ 2 years of laboratory-based experience.
The selected candidate must possess knowledge &/or competencies related to:
- Protein and peptide chemistry;
- Formulation and drug delivery/device development
- Drug product manufacturing
Experience with both conventional and alternative protein formulation and drug delivery/device approaches, and analytical methods used to critically assess formulation and product quality is highly desirable. Ability to become competent using bioanalytical and biophysical techniques for product characterization and stability evaluation is essential; including, e.g., HPLC, capillary electrophoresis, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), & DSC.
The candidate must be a creative and motivated self-starter, with excellent verbal and written communication skills, and the ability to work effectively in team and matrix environments. The candidate must be able to demonstrate the following:
- Ability to maintain accurate, complete laboratory records
- Experience with biopharmaceutical protein formulation and drug product manufacturing
- Experience and understanding of bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation; including, e.g., HPLC, capillary electrophoresis, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), & DSC, and the ability to contribute analytically.
The successful candidate will join a Product Development Team within the Biopharmaceutical Product Sciences (BPS) department of the Biopharm Product Development & Supply organization within GSK R&D and will work on developing drug product and delivery systems for protein & peptide-based therapeutics. Specific responsibilities will be focused around laboratory experimentation, analytical testing, and secondary manufacturing of putative formulations & drug delivery approaches for select protein therapeutics, which includes contributing to conception & evaluation of conventional & novel product matrices and administration modalities; physicochemical and bioanalytical characterization of native and modified biopharm compounds; working with the Bioanalytical Sciences group to define and identify methods to monitor quality attributes for use in product development, release and stability testing; crafting & execution of non-GMP studies to generate product knowledge, and interfacing with the quality organization to craft GMP stability protocols and assess resultant data; 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; and, assisting in preparation and review of manufacturing batch records, SOPs, and regulatory documentation, as appropriate.
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