Director Formulation Development Jobs in Indianapolis, IN

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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, you'll 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 Sr. Associate / Consultant Formulation Scientist on the Biopharma Technical Development - Formulations 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.

You will drive the execution of formulation development studies across development stages for sterile injectable and freeze-dried (lyophilized) drug products. You will partner closely with scientists in downstream process development, analytical sciences, and other CMC functions to deliver high-quality 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 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).

Implement and oversee automated equipment/workflows to improve efficiency.

Support the manufacturing of materials for early clinical trials by performing aseptic filling, utilizing single-use systems, peristaltic pumps, and small-scale filling assemblies.

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.

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.

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).

Hands-on experience with laboratory automation and high-throughput screening platforms, including programming and operating systems.

Demonstrated experience in aseptic processing and manual/semi-automated filling operations.

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.

What Will Give You a Competitive Edge (Preferred 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).

Additional Information

Location: Global Elanco Headquarters - Indianapolis, IN (Hybrid Work Environment)

Travel: Minimal (e.g., occasional travel to development or manufacturing sites)

Don't meet every single requirement?Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching

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.

#LI-RH1

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.