Sr. Associate/Consultant - Biopharma Formulations

Role Summary

Sr. Associate/Consultant Formulation Scientist on the Biopharma Technical Development – Formulations team, contributing to the development of stable and robust formulations and drug product processes for new biological therapeutics. The role focuses on formulation and drug product process development for biopharmaceutical modalities such as monoclonal antibodies, therapeutic proteins, peptides, and other complex biologics, across development stages for sterile injectables and lyophilized products. Collaboration with downstream process development, analytical sciences, and other CMC functions is essential to deliver high-quality formulation and drug product process development packages for clinical and commercial supply.

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 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.

Qualifications

• Required: Education — B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific/engineering discipline.
• Required: 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.
• Technical Skills — Familiarity with biophysical and analytical characterization techniques commonly used in biologics formulation (e.g., DSC, DLS/Zetasizer, SEC or related chromatographic methods).
• Technical Skills — Strong skills in quantitative data analysis, scientific problem‑solving, and clear written and verbal scientific communication.
• Technical Skills — Comfort working in a highly regulated, quality‑focused laboratory environment and following safety, compliance, and data‑integrity practices.
• Preferred: 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).
• Preferred: Direct experience developing freeze-dried formulations and lyophilization cycles.
• Preferred: Proven technical agility and a track record of proactively identifying and solving complex formulation or process challenges.
• Preferred: Experience using statistical tools (e.g., JMP or similar) for design of experiments (DoE) and data analysis.
• Preferred: Prior experience collaborating on cross‑functional CMC teams and/or supporting technology transfer to clinical or commercial manufacturing sites.
• Preferred: Demonstrated interest in innovation and continuous improvement (e.g., implementation of new biophysical methods, automation, or digital data workflows).

Skills

• Hands-on formulation development of biologics, including monoclonal antibodies, therapeutic proteins, and peptides.
• Biophysical and analytical characterization techniques relevant to biologics formulation (DSC, DLS/Zetasizer, SEC, etc.).
• Quantitative data analysis and scientific problem solving.
• Effective written and verbal scientific communication; ability to document work and present findings clearly.

Education

• B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related field.

Additional Information

• Location: Global Elanco Headquarters – Indianapolis, IN (Hybrid Work Environment)
• Travel: Minimal (e.g., occasional travel to development or manufacturing sites)