Sign upLog in

Senior Associate Scientist/Biologics Formulation and Drug Product Development

Elanco US Inc

Indianapolis, IN

Apply
JOB DETAILS
SKILLS
Analysis Skills, Analytical Development, Animal Care, Antibodies, Artificial Intelligence (AI), Automation, Biochemistry, Biological Processes, Biotech and Pharmaceutical, Chemical Engineering, Chemistry, Chromatography, Continuous Improvement, Cross-Functional, Data Analysis, Data Sets, Disease Prevention and Control, Diversity, Dosage Forms, Drug Development, Drug Products, Experiment Design, HTML (HyperText Markup Language), Laboratory Notebook, Laboratory Techniques, Manufacturing, Presentation/Verbal Skills, Process Development, Product Development, Quantitative Analysis, Regulatory Submissions, Safety Compliance, Securities and Exchange Commission (SEC), Service Delivery, Stress Testing, Technical Presentation, Technical Support, Time Management, Willing to Travel, Writing Skills
LOCATION
Indianapolis, IN
POSTED
12 days ago
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, youll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals lives better makes life better - join our team today! About the Role As a Senior Scientist in Biologics Formulation and Drug Product Development team, you will be a key, handson contributor in developing stable and robust formulations and drug product processes for new biological therapeutics. In this laboratorybased 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. You will drive the execution of formulation development studies across development stages for sterile injectable and freezedried (lyophilized) drug products. You will partner closely with scientists in downstream process development, analytical sciences, and other CMC functions to deliver highquality formulation and drug product process development packages that enable successful clinical and commercial supply. Your Responsibilities - Plan and perform early developability and pre-formulation assessments (e.g., stress testing, formulation screening, and phaseappropriate 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, multidose vials, and other presentations). - Anticipate and resolve key technical and processrelated challenges to meet project timelines and deliverables. - Analyze complex data sets, draw clear conclusions, and provide timely feedback and recommendations to enable datadriven formulation decisions. - Document experimental work in electronic lab notebooks and author concise technical reports and presentations to support internal decisionmaking 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. What You Need to Succeed (Minimum Qualifications) - Education: - B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific/engineering discipline. ```{=html} ``` - 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. ```{=html} ``` - Technical Skills: - Demonstrated, handson 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 s ills in quantitative data analysis, scientific problemsolving, and clear written and verbal scientific communication. - Comfort working in a highly regulated, qualityfocused laboratory environment and following safety, compliance, and dataintegrity practices. What Will Give You a Competitive Edge (Preferred Qualifications) - Direct experience with multiple dosage forms and presentations (e.g., sterile injectables, lyophilized products, multidose vials, prefilled syringes, or other devicecontaining 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 crossfunctional 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). Additional Information - Location: Global Elanco Headquarters - Indianapolis, IN (Hybrid Work Environment) - Travel: Minimal (e.g., occasional travel to development or manufacturing sites) Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against jobrelated criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.

About the Company

E

Elanco US Inc