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As a Research Scientist on the Biopharma Process Development (BPD) team, you are responsible for oversight and execution of critical upstream and downstream development activities across a wide range of Elanco’s biotechnology therapeutics programs.  This role has a particular focus on technical transfer activities and oversight of bioprocess related activities at 3rd party CDMOs.  The incumbent is expected to work extensively with sending site scientific leads and receiving site SMEs to ensure on-time delivery and high-fidelity process execution.  This individual will work collaboratively with biopharma CMC teams, technical project leads, and senior leadership to ensure clear, concise, and timely communication of project activities and milestones – leveraging technical expertise to proactively identify project risks and mitigation strategies.  It is expected that the incumbent will work with relevant QA and Regulatory partners to ensure compliance with both Elanco’s internal expectations and global quality standards.  Overall, the Research Scientist will serve an essential function to bridge internal process development teams with both internal and external manufacturing teams, ensuring successful completion of engineering, CT, PPQ/Registration, and early commercial drug substance batches.

Functions, Duties, Tasks:

• Oversee all aspects of process transfer activities for biotechnology products to internal and/or external CDMOs
• Manage all associated relationships with sending and receiving site SMEs, project leaders, and tech transfer leads.
• Author, review, and edit technical documents, protocols, and reports, ensuring compliance with Good Manufacturing Practice (GMP) or other applicable regulatory/quality requirements.
• Communicate regularly to project and technical teams, as well as senior management regarding project progress, risks, gaps, and mitigation strategies.
• Travel to both sending site and receiving site as needed to ensure successful process transfer and facilitate timely communication

Minimum Qualification (education, experience and/or training, required certifications):

Education/Experience:

Ph.D. in biology, biochemistry, biotechnology or a related field with a minimum of 5 years of experience in the pharmaceutical industry

-OR-

M.S. in the above listed fields with a minimum of 10 years of experience

Knowledge, Skills, Abilities:

• Demonstrated experience with either upstream or downstream process development for mammalian cell culture derived biotechnology products
• Experience managing technical activities with external CDMOs or CDMO experience managing client projects
• Execution or oversight of work in a regulated environment
• Excellent communication and organizational skills; attention to detail
• Demonstrated experience with authoring and editing technical documents

Additional Preferences:

• Experience in both upstream and downstream process development with CHO-cell bioprocess for mAbs and/or protein therapeutics
• Thorough understanding of GMP requirements, quality systems, and associated regulatory structures.
• Experience with technical and process transfer of mammalian bioprocess from development to manufacturing, preferably to 3rd Party CDMOs
• Experience with statistical approaches to experimental design (DoE) and the ability to analyze, interpret, and document complex data.
• Demonstrated ability to lead projects and contribute to technical risk assessments and root cause investigations.
• Experience working with a global technical team across multiple geographies and technical backgrounds.

Other Information:

• Expected travel approximately 25%
• Flexible working hours needed to accommodate global programs and stakeholders in APAC, UK/EU and USA

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

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