Senior Associate Scientist – Biologics Formulation & Drug Product Development

About the role

As a Senior Scientist in Biologics Formulation & Drug Product Development team, you will be a key, hands-on contributor in developing stable and robust formulations and drug product processes for new biological therapeutics. In this laboratory-based role, you will focus on formulation and drug product process development for biopharmaceutical modalities such as monoclonal antibodies, therapeutic proteins, peptides, and other complex biologics.

Responsibilities

• Plan and perform early developability and pre-formulation assessments (e.g., stress testing, formulation screening, and phase-appropriate stability studies) using biophysical and analytical tools (such as DSC, DLS / Zetasizer, particulate analysis, SEC and related techniques) to enable lead candidate and formulation selection.
• Design, plan, and execute formulation and process development studies for biological drug products (e.g., sterile injectables, lyophilized products, multi-dose vials, and other presentations).
• Anticipate and resolve key technical and process-related challenges to meet project timelines and deliverables.
• Analyze complex data sets, draw clear conclusions, and provide timely feedback and recommendations to enable data-driven formulation decisions.
• Document experimental work in electronic lab notebooks and author concise technical reports and presentations to support internal decision-making and, as appropriate, regulatory submissions.
• Collaborate closely with downstream/process development, analytical sciences, device/packaging, manufacturing, and quality teams to translate laboratory findings into robust, scalable drug product processes.
• Contribute to continuous improvement of formulation development workflows, analytical capabilities, and laboratory practices, including evaluation and implementation of new technologies where appropriate.

Requirements

• Education: B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific/engineering discipline.
• Experience: B.S. with 5-7+ years of relevant industry experience, or M.S. with 3+ years of relevant industry experience, in formulation development of biologics or other biopharmaceutical products.
• Technical Skills: Demonstrated, hands-on experience in formulation development of monoclonal antibodies, therapeutic proteins, peptides, or other biopharmaceutical drug products. Familiarity with biophysical and analytical characterization techniques commonly used in biologics formulation (e.g., DSC, DLS/Zetasizer, SEC or related chromatographic methods). Strong skills in quantitative data analysis, scientific problem-solving, and clear written and verbal scientific communication. Comfort working in a highly regulated, quality-focused laboratory environment and following safety, compliance, and data-integrity practices.

Qualifications

• Direct experience with multiple dosage forms and presentations (e.g., sterile injectables, lyophilized products, multi-dose vials, pre-filled syringes, or other device-containing presentations).
• Direct experience developing freeze-dried formulations and lyophilization cycles.
• Proven technical agility and a track record of proactively identifying and solving complex formulation or process challenges.
• Experience using statistical tools (e.g., JMP or similar) for design of experiments (DoE) and data analysis.
• Prior experience collaborating on cross-functional CMC teams and/or supporting technology transfer to clinical or commercial manufacturing sites.
• Demonstrated interest in innovation and continuous improvement (e.g., implementation of new biophysical methods, automation, or digital data workflows).