Manufacturing Science Lead Engineer/Scientist Drug Substance

SUMMARY:

The Lead Engineer/Scientist is an integral part of the Manufacturing Sciences Organization and is responsible for supporting the production of clinical and/or commercial Viral Vector in one or more areas of Kriya’s RTP Viral Vector Manufacturing facility with primary support for Drug Substance. The focus of this position is to provide vector drug substance process support and expertise for leading and managing process transfer to support GMP manufacturing operations.

PRIMARY RESPONSIBILITIES:

• Serve as the technical expert for drug substance manufacturing (upstream and/or downstream).
• Define, measure, analyze, and propose improvements to the current process and systems.
• Participates in or leads (as necessary) cross functional teams for tech transfer and manufacturing support. May participate on sub-teams and work as a point of contact for programs.
• Provide technical support of GMP manufacturing runs and hands-on support as needed for rapid troubleshooting.
• Author and execute engineering studies, technical reports, and process validation protocols.

PREFERRED SKILLS:

• Experience in GMP manufacturing or manufacturing support
• Highly self-motivated and detail-oriented, with proven ability to foster strong relationships with other team members and stakeholders
• Experience with single use bioreactors is preferred
• Experience with Akta chromatography skids is preferred
• Perform as the Subject Matter Expert (SME) on a variety of projects and range of technologies.
• Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required.
• Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required.

EDUCATION/TRAINING:

• Master’s degree, preferably in Science, Engineering or other related field and 2-4 years of relevant related experience OR
• Bachelor’s degree, preferably in Science, Engineering or other related field and 4-6 years of relevant related experience OR
• Associate’s degree, preferably in Science, Engineering or other related field and 6-8 years of relevant related experience.

Level commensurate with experience.