Senior Research Scientist - Biopharma Process Development

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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, ...