Senior Scientist – Biologics Formulation & Drug Product Development
Elanco
10 hours ago
Remote friendly (Indianapolis, IN)
United States
Operations
Senior Scientist, Biologics Formulation & Drug Product Development
Responsibilities:
- Plan and perform early developability and pre-formulation assessments (e.g., stress testing, formulation screening, phase-appropriate stability studies) using biophysical/analytical tools (e.g., DSC, DLS/Zetasizer, particulate analysis, SEC).
- Design, plan, and execute formulation and process development studies for biological drug products (e.g., sterile injectables, lyophilized products, multi-dose vials, other presentations).
- Anticipate and resolve technical and process-related challenges to meet project timelines and deliverables.
- Analyze complex data sets, draw clear conclusions, and provide timely recommendations for data-driven formulation decisions.
- Document experiments in electronic lab notebooks; author technical reports and presentations to support internal decisions and, when appropriate, regulatory submissions.
- Collaborate with downstream/process development, analytical sciences, device/packaging, manufacturing, and quality teams to translate lab findings into robust, scalable processes.
- Contribute to continuous improvement of formulation development workflows, analytical capabilities, and lab practices, including evaluating/implementing new technologies.
Qualifications (Minimum):
- Education: B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related discipline.
- Experience: B.S. with 5–7+ years (or M.S. with 3+ years) in formulation development of biologics/biopharmaceutical products.
- Skills: Hands-on formulation development experience with monoclonal antibodies, therapeutic proteins, peptides, or other biologics; familiarity with biologics biophysical/analytical characterization (e.g., DSC, DLS/Zetasizer, SEC); strong quantitative data analysis and scientific communication; ability to work in a highly regulated, quality-focused lab following safety, compliance, and data-integrity practices.
Qualifications (Preferred):
- Experience with multiple dosage forms/presentations (e.g., sterile injectables, lyophilized products, multi-dose vials, pre-filled syringes).
- Experience developing freeze-dried formulations and lyophilization cycles.
- Track record of proactively identifying and solving complex formulation/process challenges.
- Experience with statistical tools (e.g., JMP) for DoE and data analysis.
- Experience collaborating on cross-functional CMC teams and/or supporting technology transfer to manufacturing sites.
- Interest in innovation and continuous improvement (e.g., new biophysical methods, automation, digital workflows).
Additional information:
- Location: Indianapolis, IN (Hybrid Work Environment)
- Travel: Minimal (occasional travel to development or manufacturing sites)
Responsibilities:
- Plan and perform early developability and pre-formulation assessments (e.g., stress testing, formulation screening, phase-appropriate stability studies) using biophysical/analytical tools (e.g., DSC, DLS/Zetasizer, particulate analysis, SEC).
- Design, plan, and execute formulation and process development studies for biological drug products (e.g., sterile injectables, lyophilized products, multi-dose vials, other presentations).
- Anticipate and resolve technical and process-related challenges to meet project timelines and deliverables.
- Analyze complex data sets, draw clear conclusions, and provide timely recommendations for data-driven formulation decisions.
- Document experiments in electronic lab notebooks; author technical reports and presentations to support internal decisions and, when appropriate, regulatory submissions.
- Collaborate with downstream/process development, analytical sciences, device/packaging, manufacturing, and quality teams to translate lab findings into robust, scalable processes.
- Contribute to continuous improvement of formulation development workflows, analytical capabilities, and lab practices, including evaluating/implementing new technologies.
Qualifications (Minimum):
- Education: B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related discipline.
- Experience: B.S. with 5–7+ years (or M.S. with 3+ years) in formulation development of biologics/biopharmaceutical products.
- Skills: Hands-on formulation development experience with monoclonal antibodies, therapeutic proteins, peptides, or other biologics; familiarity with biologics biophysical/analytical characterization (e.g., DSC, DLS/Zetasizer, SEC); strong quantitative data analysis and scientific communication; ability to work in a highly regulated, quality-focused lab following safety, compliance, and data-integrity practices.
Qualifications (Preferred):
- Experience with multiple dosage forms/presentations (e.g., sterile injectables, lyophilized products, multi-dose vials, pre-filled syringes).
- Experience developing freeze-dried formulations and lyophilization cycles.
- Track record of proactively identifying and solving complex formulation/process challenges.
- Experience with statistical tools (e.g., JMP) for DoE and data analysis.
- Experience collaborating on cross-functional CMC teams and/or supporting technology transfer to manufacturing sites.
- Interest in innovation and continuous improvement (e.g., new biophysical methods, automation, digital workflows).
Additional information:
- Location: Indianapolis, IN (Hybrid Work Environment)
- Travel: Minimal (occasional travel to development or manufacturing sites)