Principal Scientist

GSK•Upper Providence, PA

About The Position

Formulation and Process Development, within the Drug Product Development (DPD) department, is part of the wider R&D Drug Development and Supply organization, and is a highly experienced Chemistry, Manufacturing and Controls (CMC) organization accountable for delivering robust, cost effective and competitive product and manufacturing processes spanning the full life-cycle of asset development from discovery through commercialization. These activities are delivered through state-of-the-art internal facilities as well as strategic external partners. Collectively, the team is accountable for CMC activities encompassing both small molecule and large molecule (biopharma) drug product development. We also pioneer innovative technologies and employ data science to improve robustness, reduce cost of goods, and improve the patient experience. Within Drug Product Development (DPD), the Formulation and Process Development (FPD) department focuses on developing world class patient-centric biopharmaceutical and small-molecule drug products through innovation, technology and strategic partnering. The successful candidate for this position will focus on biopharmaceutical drug product development for protein (e.g., mAbs, bispecific mAbs, antibody-drug-conjugates (ADCs)) and peptide-based therapeutics. This role will focus on drug product development for assets being developed for Clinical Phases 2 and 3, and commercialization. Associated activities may include protein formulation optimization and development stability assessment, in-use compatibility/stability assessments to support product administration, drug product process development, characterization, and technical transfer activities to a GMP manufacturing facility. Role responsibilities may include matrix leadership and working with other departments to progress drug product development. Responsibilities may also include laboratory experimentation, with application of biophysical techniques and development (non-GMP) stability studies to optimize protein formulation. The position will also require authoring of technical and regulatory documents, maintaining accurate, complete electronic laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques. Because the department encompasses both small molecule and large molecule (biopharma) development, there may also be opportunities to contribute to development of small molecule drug products (e.g., chemical entities and oligonucleotides).

Requirements

PhD degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biology, Bioengineering, Biomedical engineering, or Chemical Engineering with 0+ years of protein formulation and/or process development or, MS degree with 5+ years of industry experience; or, BS degree with 7+ years of industry experience.
Experience in authoring technical documents

Nice To Haves

Experience working with antibody-drug-conjugates (ADCs).
Experience or ability to interpret results from multiple bioanalytical techniques for product characterization and product stability evaluation.
Experience with both conventional and alternative biopharmaceutical protein formulation and drug product stability evaluation, including the application of DOE and other statistically based experimental design/interpretation approaches.
Experience with protein drug 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 with biophysical techniques for product characterization and stability evaluation is valuable, e.g., DSC, DSF (experience with Uncle or Prometheus Panta), particles size evaluation (MFI, FlowCam), light scattering, etc.
Experience in authoring regulatory documentation (IND/IMPD, BLA/MAA, etc.); contributing to, and critical review of successful regulatory submissions; with particular emphasis on late clinical phase submissions, and response to regulatory questions.
Experience in drug product manufacturing technology transfer to commercial and/or scale-up of clinical drug product manufacturing capabilities.
Experience working with Biopharm combination products.
Creative and motivated self-starter, with excellent verbal and written communication skills, demonstrated ability to work independently and ability to work effectively in team and matrix environments.
Experience maintaining accurate, complete laboratory records and facile use of electronic data & information gathering, capture, archiving and communications techniques.

Responsibilities

Matrix leadership and working with other departments to progress drug product development.
Laboratory experimentation, with application of biophysical techniques and development (non-GMP) stability studies to optimize protein formulation.
Authoring of technical and regulatory documents.
Maintaining accurate, complete electronic laboratory records.
Facile use of electronic data & information gathering, capture, archiving and communications techniques.
Contribute to development of small molecule drug products (e.g., chemical entities and oligonucleotides).