Site Name:
USA - Pennsylvania - Upper Providence
Posted Date:
Sep 5 2024
Are you a scientist in sterile product formulation and injectables eager to lead the development of life-changing drug products? Are you eager to unite science, talent, and technology to get ahead of disease together? This may be the right opportunity for you!
This role is Hybrid at our Upper Providence, PA site and does require minimum 2-3 days on-site per week.
As a Biopharmaceutical Drug Product, Principal Scientist/ Investigator, you will join the GSK sterile Drug Product Development organization and work on developing late phase drug product formulation, manufacturing process and delivery systems for protein-based therapeutics and NCEs.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Member of a team responsible for enabling the progression of new assets from candidate selection to product commercialization.
Design, plan and execute studies for formulation optimization, process characterizations and in-use stability/compatibility evaluations.
Provide correct interpretation of results and perform complex data management and analysis.
Physicochemical and bioanalytical characterization of native and modified biopharmaceuticals and NCEs.
Authoring & execution of non-GMP stability protocols to test quality & stability of product formulations.
Maintaining accurate, complete laboratory records.
Developing sterile product manufacturing processes, scaling up and transferring to manufacturing sites.
Author and review technical protocols and reports in support of projects in various stages of development.
Working closely with internal & external development support partners, as needed.
Facile use of electronic data & information gathering, capture, archiving and communications techniques.
Assisting in preparation and review of SOPs, and regulatory documentation, as appropriate.
Collaborate with project teams to conduct formal root cause analyses and investigations.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
PhD degree in Pharmaceutics, Biology, Biochemistry, Biotechnology, Chemistry, Chemical Engineering with protein formulation and drug delivery development experience; or MS degree with 5+ years of experience; or BS degree with 10+ more years of experience. Ph.D. with 2+ years of industry experience is preferred.
At least one year experience of protein and peptide chemistry; and Formulation and Biophysical Characterization of Biopharms.
Experience in authoring technical reports and regulatory documentation (IND/IMPD, BLA/MAA, etc.)
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
At least one year 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.
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 in 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, 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.
Demonstrated ability to work independently and the ability to work effectively in team and matrix environments.
Demonstrated ability to maintain accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.
Experience in leading a product development matrix team.
Good oral and written communication skills.
Experience with technical risk assessments (FMEA) and control strategy development.
Good knowledge of QbD as presented in regulatory dossiers.
Creative and motivated self-starter with excellent verbal and written communication skills.
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