Posted in Science 30+ days ago.
This job brought to you by eQuest
Location: collegeville, Pennsylvania
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 products, manufacturing process and delivery systems for protein & peptide-based therapeutics.
Specific responsibilities will include 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 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.
We are looking for professionals with these required skills to achieve our goals:
The selected candidate must possess knowledge &/or competencies related to:
• Protein and peptide chemistry;
• Formulation and drug delivery/device development
• Drug product manufacturing
The candidate must be able to demonstrate the following:
• Ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.
•Ability to become competent using bioanalytical and biophysical techniques for product characterization and stability evaluation; including, e.g., HPLC, capillary electrophoresis, Spectroscopy (UV/VIS, fluorescence, or CD), & DSC.
If you have the following characteristics, it would be a plus:
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
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