Scientist, Drug Product Development

About the role

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, ensuring we accelerate 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, you will develop world‑class, patient‑centric drug products through innovation, technology, and strategic partnering. The role focuses on biopharmaceutical drug product development for mAbs, bispecific mAbs, ADCs, and may include small‑molecule products such as oligonucleotides. Responsibilities include laboratory experimentation, biophysical technique application, stability studies, formulation robustness, in‑use evaluation, process development (mixing, sterile‑filtration, filling, lyophilization), tech transfer, scale‑up, and authoring of development protocols, technical reports, and regulatory documentation.

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 possesses extensive theoretical knowledge in the relevant scientific area.
• 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.

Qualifications

• Bachelor’s degree with 2 + years of relevant laboratory‑based experience or Master’s degree with 1 + year of relevant laboratory‑based experience in Pharmaceutics, Biology, Chemistry, Biochemistry, Chemical Engineering, or a related scientific discipline.
• 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.

Skills

• Drug Delivery
• Laboratory Operations
• Pharmaceutical Formulations
• Quality by Design
• Technical Writing

Benefits

Please visit the GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.