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Principal Scientist, Biopharmaceutical Product Sciences at GlaxoSmithKline

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: collegeville, Pennsylvania





Job Description:

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.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:


  • PhD degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline


  • 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.



Preferred Qualifications:

If you have the following characteristics, it would be a plus:


  • 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 and understanding of multiple bioanalytical and biophysical assessment techniques for product characterization and product stability evaluation, including HPLC, SDS-PAGE/CGE, 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.

  • Experience in authoring, contributing to, and critical review of successful regulatory submissions; with 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.

Why GSK?

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:


  • Operating at pace and agile decision-making – using evidence and applying judgment to balance pace, rigour and risk.

  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.

  • Continuously looking for opportunities to learn, build skills and share learning.

  • Sustaining energy and well-being.

  • Building strong relationships and collaboration, honest and open conversations.

  • Budgeting and cost-consciousness.

GSKBiopharm_Development

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