Principal Scientist

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. We foster a culture ambitious for patients, accountable for impact, and committed to doing the right thing.

About the role

Formulation and Process Development, within the Drug Product Development (DPD) department, is part of the wider R&D Drug Development and Supply organization. This highly experienced Chemistry, Manufacturing and Controls (CMC) team delivers robust, cost-effective, and competitive product and manufacturing processes across the full lifecycle of asset development—from discovery through commercialization. Activities are supported by state-of-the-art internal facilities and strategic external partners.

The team is accountable for CMC activities encompassing both small molecule and large molecule (biopharma) drug product development. We pioneer innovative technologies and employ data science to improve robustness, reduce cost of goods, and enhance 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 will focus on biopharmaceutical drug product development for protein-based therapeutics (e.g., mAbs, bispecific mAbs, antibody-drug-conjugates (ADCs)) and peptides. This role supports drug product development for Clinical Phases 2 and 3, and commercialization.

Responsibilities

• Lead protein formulation optimization and development stability assessments.
• Conduct in-use compatibility and stability assessments to support product administration.
• Develop, characterize, and transfer drug product processes to GMP manufacturing facilities.
• Provide matrix leadership and collaborate with cross-functional teams to advance drug product development.
• Perform laboratory experimentation, including biophysical techniques and non-GMP stability studies, to optimize protein formulations.
• Author technical and regulatory documents, ensuring accurate and complete electronic laboratory records.
• Utilize electronic data and information systems for gathering, capturing, archiving, and communication.
• Contribute to the development of small molecule drug products (e.g., chemical entities and oligonucleotides) as opportunities arise.

Qualifications

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

Skills

• Drug Delivery
• External Manufacturing
• Medical Device Evaluation
• Molecular Modeling
• Pharmaceutical Formulations
• Pharmacokinetics
• Product Design
• Product Management
• Product Planning
• Product Strategies
• Quality by Design
• Regulatory Filings
• Stability Testing
• Technology Transfer

Preferred Qualifications

• Experience working with antibody-drug-conjugates (ADCs).
• Ability to interpret results from multiple bioanalytical techniques for product characterization and stability evaluation.
• Experience with conventional and alternative biopharmaceutical protein formulation and drug product stability evaluation, including DOE and statistically based experimental design.
• Experience with protein drug product manufacturing processes (e.g., solution in vial/PFS, lyophilization), container/closure assessment, and drug delivery feasibility (e.g., combination products, devices, administration kits).
• Proficiency with biophysical techniques for product characterization (e.g., DSC, DSF, Uncle or Prometheus Panta, particle size evaluation via MFI or FlowCam, light scattering).
• Experience authoring regulatory documentation (IND/IMPD, BLA/MAA) and contributing to successful regulatory submissions, particularly for late clinical phases and responses to regulatory questions.
• Experience in drug product manufacturing technology transfer and scale-up of clinical drug product manufacturing.
• Experience working with biopharmaceutical combination products.
• Strong verbal and written communication skills, with a demonstrated ability to work independently and collaboratively in team and matrix environments.
• Commitment to maintaining accurate, complete laboratory records and proficiency in electronic data management.

Benefits

Visit the GSK US Benefits Summary to learn more about the comprehensive benefits program offered to US employees.