Sr. Associate/Consultant - Biopharma Formulations jobs in United States
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Elanco · 1 day ago

Sr. Associate/Consultant - Biopharma Formulations

Elanco is a global leader in animal health dedicated to innovation and delivering products and services for animals. The Sr. Associate / Consultant Formulation Scientist will develop stable formulations and drug product processes for biological therapeutics, collaborating with various teams to ensure high-quality development packages for clinical and commercial supply.

ManufacturingPetSupply Chain Management

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)
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

Qualification

Formulation developmentBiopharmaceuticalsAnalytical techniquesData analysisQuality complianceTechnical communicationContinuous improvementProblem-solvingCollaboration

Required

B.S. or M.S. in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific/engineering discipline
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
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)
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

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)
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)

Company

Elanco is an animal health company that manufactures and markets a diverse range of products to promote animal health and well-being.

Funding

Current Stage
Public Company
Total Funding
$252.86M
Key Investors
AncoraBill & Melinda Gates Foundation
2023-12-30Post Ipo Equity· $250M
2018-09-19IPO
2017-05-24Grant· $2.86M

Leadership Team

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Dave Kinard
Executive Vice President Human Resources, Corporate Affairs & Administration
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Jennifer Black
Senior Director, Global Indirect Procurement
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Company data provided by crunchbase