Senior Biologics Formulations Scientist — Sterile Process, AI PM

Elanco in; Indianapolis (IN); On-site; USD 142,000 - 174,000; Full time

Benefits offered by this job

relocation packages

shutdowns in US

8-week parental leave

Employee Resource Groups

Annual bonus

Flexible work arrangements

401K matching

Job summary

Elanco is seeking a Senior Research Scientist, Biologics Drug Product Formulation & Sterile Process Development, based in Indianapolis. The role focuses on developing robust formulations and manufacturing processes for biopharmaceuticals including monoclonal antibodies, recombinant proteins, and vaccines.

You will leverage automation, high-throughput screening, and AI/ML tools to accelerate development and streamline regulatory submissions.

Qualifications

• Ph.D. in pharmaceutical sciences/biochemistry/chemical/biomedical engineering or related field with 5+ years in biologics formulation and sterile manufacturing.
• Authorized to work in the United States.

Responsibilities

• Lead design and development of biologics formulations and sterile processes.
• Apply HTS, automation, and AI/ML to improve formulation development timelines.
• Coordinate tech transfer from R&D to manufacturing sites.
• Provide technical oversight for CROs/CMOs and external collaborators.
• Lead Manufacturability Review and support regulatory submissions (CMC).
• Write and review technical reports, batch records, and regulatory documents.
• Collaborate across discovery, development, manufacturing and quality teams.

Education

PhD or MS in related field with experience

Job description

Elanco is seeking a Senior Research Scientist, Biologics Drug Product Formulation & Sterile Process Development, based in Indianapolis. The role focuses on developing robust formulations and manufacturing processes for biopharmaceuticals including monoclonal antibodies, recombinant proteins, and vaccines.

You will leverage automation, high-throughput screening, and AI/ML tools to accelerate development and streamline regulatory submissions.