Investigator, Biopharmaceutical Product Sciences
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, manufacturing process and delivery systems for protein & peptide-based therapeutics.
Specific responsibilities will be focused around laboratory experimentation and analytical testing of putative formulations & drug product manufacturing and administration/delivery approaches for select protein therapeutic assets, which includes contributing to the conception & evaluation of conventional & novel product matrices and administration modalities; working closely with the manufacturing groups during process development and technology transfer; actively participating with combination drug product assessment and collaborating with device engineering, 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, release & stability testing; crafting & execution of non-GMP stability protocols to test quality & stability of product formulations, and interfacing with the Analytical Technology Transfer and Stability group 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.
The ideal candidate will have a PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline with 1-3 years of protein formulation and drug delivery development experience; or, MS degree with 5-7 years of similar experience; or, BS degree with 10 or more years of similar 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 protein product manufacturing processes and development (e.g., solution (vial/PFS), lyophilization or spray drying; container/closure assessment & selection), drug delivery (e.g., combination product, device & administration kit feasibility and compatibility evaluation), and bioanalytical/biophysical techniques for product characterization and stability evaluation is essential; including, e.g., HPLC, SDS-PAGE/CGE/cSDS, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), & DSC, particles evaluation by HIAC and/or orthogonal techniques (eg MFI, FlowCam, Archimedes), capillary electrophoresis & chip-based methods, etc.
The candidate must be a creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and the ability to work effectively in team and matrix environments. The candidate must be able to demonstrate the ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.
The ideal candidate's ability to demonstrate the following is highly desirable:
•Experience with both conventional and alternative biopharmaceutical protein formulation, and drug product development, including the application of DOE and other statistically-based experimental design/interpretation approaches.
•Experience with protein product manufacturing processes and development (e.g., solution (vial/PFS), or lyophilization; container/closure assessment & selection), drug delivery (e.g., combination product, device & administration kit) feasibility and compatibility evaluation.
•Experience in authoring, contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions, BLA/MAA filings, response to regulatory questions, and pre-approval inspection experience.
•Experience in working with in vivo/ in vitro models to critically assess formulation & delivery modalities.
•Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities would be beneficial.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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