Sr. Associate / Consultant Formulation Scientist – Biopharma

Elanco Tiergesundheit AG; Indianapolis (IN); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Multiple relocation packages

Two weeklong shutdowns in US

8-week parental leave

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Elanco Animal Health Incorporated in Indianapolis, IN is seeking a Sr. Associate/Consultant Formulation Scientist to advance stable formulations and drug product processes for biopharmaceutical modalities, including monoclonal antibodies and therapeutic proteins, in a lab-based setting.

You will drive development studies across stages for sterile injectables and lyophilized products, collaborating with cross-functional teams to deliver robust processes for clinical and commercial supply.

Qualifications

• BS or MS in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific/engineering discipline.
• 5–7+ years with BS or 3+ years with MS in formulation development of biologics.
• Hands-on experience with monoclonal antibodies, therapeutic proteins, peptides, or other biopharmaceutical products.

Responsibilities

• Plan early developability assessments using biophysical/analytical tools (DSC, DLS, SEC) to enable lead selection.
• Design and execute formulation and process development studies for sterile injectables and lyophilized products.
• Implement and oversee automated equipment/workflows to improve efficiency.
• Support manufacturing for early clinical trials by aseptic filling and single-use systems.
• Collaborate with downstream/process development, analytical sciences, device/packaging, manufacturing and quality teams.
• Document work in electronic lab notebooks and prepare technical reports for decisions and regulatory submissions.

Skills

Biopharm formulation

High-throughput screening

Aseptic processing

Data analysis

Lab automation

Education

Bachelor's or MS in Pharmaceutical Sciences

Tools

DSC

DLS

SEC

Automation

Filling equipment

Job description

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)

Elanco Benefits and Perks

• 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 job‑related 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.
• 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 job‑related 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.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.