The successful candidate will join a Technology 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 new technologies to support drug product and delivery systems for protein & peptide-based therapeutics. The candidate will primarily support implementation of new technologies for Biopharm drug product development: the implementation of automation for formulation and drug product development; drug product manufacturing process development and transfer; and combination product and device development activities related to new technologies for new products in the pipeline. A scientist in this role will be expected to rotate between other BPDS departments to support the flexible product development initiative.
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; 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 BS degree in Pharmaceutics, Biology, Biochemistry, Chemistry, Chemical Engineering, or related scientific discipline with at least 1 year of years of relevant laboratory-based experience.
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 following:
• Ability to maintain accurate, complete laboratory records
• Ability to become competent using bioanalytical and biophysical techniques for product characterization and stability evaluation is desirable; including, e.g., HPLC, capillary electrophoresis, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), & DSC.
• Knowledge of Protein or peptide chemistry
• Master's degree with 2 years of laboratory-based experience in a pharmaceutical environment.
• Experience related to knowledge &/or competencies in one or more of the following areas is highly desirable:
o Implementing Automation or high aptitude for automation and data management
o Combination product and device development
o Conventional and alternative protein formulation and drug delivery/device development
o Drug product manufacturing Experience with biopharmaceutical protein formulation and drug product manufacturing
o Bioanalytical and biophysical techniques for product characterization and stability evaluation including, e.g., HPLC, capillary electrophoresis, SEC, Spectroscopy (UV/VIS, fluorescence, or CD), DSC, particle techniques.
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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