Biopharmaceutical Drug Product, Principal Scientist/ Investigator
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Sep 24 2020
If you are looking for the opportunity to support early-phase assets through formulation development and product development, keep reading.
As a Biopharmaceutical Drug Product, Principal Scientist/ Investigator you 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 formulation, manufacturing process and delivery systems for protein & peptide-based therapeutics.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- 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
- Physicochemical and bioanalytical characterization of native and modified biopharm compounds
- Crafting & execution of non-GMP stability protocols to test quality & stability of product formulations
- 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
- Assisting in preparation and review of SOPs, and regulatory documentation, as appropriate
Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- Bachelor's degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline with least 10 years of relevant experience.
- Experience withprotein and peptide chemistry; and Formulation and Biophysical Characterization of Biopharms
- Experience with biophysical techniques for product characterization and stability evaluation is essential; including, e.g., Spectroscopy (UV/VIS, fluorescence, or CD), Differential Scanning Calorimetry, UNit/ UNcle, Prometheus, particles size evaluation (MFI, FlowCam, Archimedes), light scattering, Isothermal Calorimetry.
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- Master's degree in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline with 5-7 years of similar experience
PhD in Pharmaceutics, Biology, Chemistry, Chemical Engineering, or related scientific discipline with 0-3 years of protein formulation and drug delivery development experience.
- Experience and understanding of multiple bioanalytical techniques for product characterization and product stability evaluation, including HPLC, SDS-PAGE/CGE, SEC, capillary electrophoresis & chip-based methods, etc.
- 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 early clinical phase submissions, and response to regulatory questions.
- 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.
- 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.
- Able to demonstrate the ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.
Why GSK? Our values and expectationsare 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 judgement 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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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