Scientist, Drug Product Development

GSK•Upper Providence, PA

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. As a Scientist or Senior Scientist in the Formulation and Process Development department, within Drug Product Development at GSK, you will focus on developing world class patient-centric drug products through innovation, technology and strategic partnering. The successful candidate for this position will focus on biopharmaceutical drug product development for mAbs, bispecific mAbs, ADCs, etc. The department may also provide opportunities to contribute to development of small molecule drug products, including oligonucleotides. Role responsibilities will be focused on laboratory experimentation, with application of biophysical techniques and development stability studies to optimize protein formulations. Role responsibilities will also include formulation robustness studies, in-use evaluation to ensure product quality during product administration, performing process development studies (e.g., for mixing, sterile-filtration, filling, and where applicable, lyophilization). The role will also include contributing to tech transfer and scale-up for clinical and commercial drug product manufacturing. Responsibilities will include authoring of development protocols and technical reports and other related documentation, and supportive authoring of regulatory documents (e.g., sections of IND, IMPD, BLA, MAA). Responsibilities will involve working closely with internal & external development support partners (e.g., Analytical Development, Manufacturing Sciences and Technology, etc.), maintaining accurate, complete electronic laboratory records; facile use of electronic data & information gathering, capture, archiving and communications techniques.

Requirements

Bachelor’s degree with 2+ years of relevant laboratory-based experience or Master’s degree with 1+ years of relevant laboratory-based experience with the degree in Pharmaceutics, Biology, Chemistry, Biochemistry, Chemical Engineering, or related scientific discipline

Nice To Haves

Knowledge and/ or experience in protein chemistry/structure, protein formulation and drug delivery/device development, and drug product manufacturing (fill-finish) and process development
Knowledge and/ or experience with in-use/administration compatibility studies
Experience using biophysical or other techniques for product characterization and assessment of product stability (e.g., SLS, DLS, DSC, MFI, HIAC)
Technical report writing and regulatory documentation authoring experience (IND/IMPD, BLA/MAA, etc.).
Creative and motivated self-starter
Strong organizational skills
Maintains accurate and complete laboratory records
Ability to work effectively in a team and matrix environment
Excellent verbal communication and technical writing skills

Responsibilities

Designs and executes study protocols
Executes a wide range of experiments and development studies independently based on a protocol
Identifies and troubleshoots problems in the execution of experimental processes, technical studies, and tasks.
Understands the rationale and hypotheses for experimental designs and/or has an extensive theoretical understanding of a particular area of science.
Develops understanding of regulatory requirements
Complies with and contributes to document content and data integrity requirements
Authors protocols, technical reports and sections of regulatory documentation