Biologics Process Development Jobs (NOW HIRING)

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Elanco is seeking a Senior Scientist, Downstream Process Development to lead purification process development for biologic drug substances, with a focus on monoclonal antibodies, therapeutic proteins, and mammalian cell culture-derived biologics.

This role will support programs from bench and pilot scale through process scale-up, technology transfer, process characterization, GMP manufacturing implementation, clinical material production, and CMC/regulatory filing support.

The ideal candidate will have hands-on experience developing and optimizing downstream purification processes, including chromatography and filtration-based unit operations such as Protein A or affinity chromatography, ion exchange chromatography, polishing steps, viral clearance or viral inactivation, depth filtration, UF/DF, TFF, and scale-down model development.

You will partner closely with R&D, TS/MS, Manufacturing, Quality, Supply Chain, Regulatory, and external CDMOs to ensure successful process transfer, implementation, and commercialization. This role requires strong technical judgment, clear communication, and the ability to lead cross-functional work in a fast-paced biologics development environment.

• Lead downstream process development for early- and late-stage biologic programs, including monoclonal antibodies, therapeutic proteins, and other biologic modalities.

• Develop and optimize purification processes using phase-appropriate strategies, QbD principles, and process characterization approaches.

• Design and execute bench- and pilot-scale studies, including scale-down model development, process scale-up, and manufacturing support.

• Support risk assessments, control strategy development, stage-gate reviews, and technical decision-making for biologic drug substance programs.

• Author and review technical reports, process development documents, tech transfer packages, and CMC source documents for regulatory submissions.

• Support responses to CMC questions from regulatory agencies.

• Partner with R&D, TS/MS, Manufacturing, Quality, Supply Chain, Regulatory, Launch Teams, and external CDMOs to ensure successful tech transfer, clinical material production, and commercialization.

• Serve as a downstream process development subject matter expert for internal teams, manufacturing sites, and external partners.

• MSc or PhD in chemistry, pharmaceutical sciences, biotechnology, chemical engineering, or a related scientific discipline. Equivalent experience may be considered.

• PhD with 7+ years or MSc with 12+ years of experience in downstream biologics process development, preferably with mammalian cell culture-derived biologic products.

• Hands-on experience developing and optimizing downstream purification processes for biologic drug substances, including monoclonal antibodies, therapeutic proteins, or other protein-based biologic modalities.

• Experience supporting late-stage development, process scale-up, technology transfer, and implementation into GMP manufacturing.

• Experience contributing to CMC/regulatory filing activities, including technical reports, source documents, process descriptions, tech transfer documents, or responses to regulatory agency questions.

• Strong understanding of downstream unit operations such as chromatography, filtration, UF/DF, TFF, polishing steps, viral clearance or viral inactivation, process characterization, and scale-down model development.

• Strong understanding of GMP, Quality by Design, process characterization, control strategy development, and risk assessment principles.

• Demonstrated success developing, scaling, transferring, or commercializing biologics, pharmaceuticals, vaccines, or other complex biological products.

• Experience working with internal manufacturing teams, TS/MS, Quality, Regulatory, Supply Chain, Launch Teams, and external CDMOs.

• Strong interpersonal and leadership skills, with the ability to influence stakeholders and lead cross-functional technical teams.

• Ability to manage multiple priorities, navigate ambiguity, and communicate complex technical information through clear writing and presentations.

• Experience with AI/ML applications in process development is a plus.

• Animal health experience is advantageous but not required.

Additional Information:

• Travel: 10-20% (domestic and international)
• Location: Indianapolis, IN - Hybrid Work Environment

Elanco Benefits and Perks:

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.

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.