Senior Scientist, Drug Product Development

Role Summary

The Senior Scientist, Drug Product Development will lead formulation and drug product (DP) development for our ADC pipeline. This individual will play a key role in establishing internal lab capabilities, executing formulation studies, developing lyophilization cycles, and partnering cross-functionally within CMC and Clinical teams. The ideal candidate will thrive in a fast-paced, startup environment and be comfortable balancing strategic planning with hands-on laboratory execution.

Responsibilities

• Lead formulation development for antibody and ADC drug products, including stability-indicating formulation screening and optimization for early and late stage products.
• Design, develop (internally and/or externally), and tech-transfer drug product processes including lyophilization, for ADC drug products to ensure manufacturability, and scalability.
• Support building internal formulation lab capabilities, including equipment selection.
• Serve as the internal subject matter expert (SME) for DP formulation and lyophilization, guiding both internal scientists, as the team expands, and external CDMOs.
• Collaborate closely with ADC DS Development, Analytical Development, QC and QA teams to ensure end-to-end alignment across CMC.
• Author and review CMC documentation, including development reports, regulatory submissions (IND/IMPD/BLA), and technical transfer packages.
• Evaluate and implement emerging technologies for ADC formulation and lyophilization to drive innovation and efficiency.
• Mentor and develop junior scientists as the team expands.

Qualifications

• A minimum of industry experience in biologics or ADC formulation and lyophilized drug product development.
• Proven expertise in lyophilization cycle development, characterization, and scale-up for biologics.
• Experience with ADCs and establishing internal lab is preferred.
• Strong hands-on experience in formulation screening, stability studies, and analytical data interpretation.
• Demonstrated experience establishing or operating in an internal lab environment.
• Excellent understanding of CMC principles and regulatory expectations for biologic and ADC drug products associated to the products’ phase.

Skills

• Deep understanding of formulation principles for biologics and ADCs, including critical quality attributes (CQAs), thermal stability and compatibility considerations.
• Proficiency in fill/finish and lyophilization process development, scale-up, optimization, tech-transfer and troubleshooting.
• Strong analytical skills for interpreting data from formulation and stability studies.
• Working knowledge of regulatory requirements for clinical and commercialization of sterile drug products, including application of Quality by Design principles
• Excellent communication and collaboration skills to work cross-functionally and with external partners.
• Ability to innovate and implement emerging technologies in drug product development.
• Ability to manage multiple projects with tight deadlines and priorities.
• Leadership skills to mentor junior scientists and/or manage projects effectively.