Advisor Research Scientist (Purification) - ADN RAMP Team

Role Summary

Advisor Research Scientist (Purification) for the ADN RAMP Team. Supports site start-ups and manufacturing scale-up for purification processes, leading transfers of new molecules, and contributing to scalable, robust manufacturing methods across Lilly API/Dry Product sites.

Responsibilities

• Lead the successful transfer of new molecules into production at Lilly Sites
• Leverage internal and external expertise to improve existing production processes focused on purification of peptides
• Establish a world class methodology to ensure new manufacturing processes are robust, cost effective and can be transitioned safely and rapidly into production
• Maintain a thorough understanding of the state of the art of manufacturing and regulatory requirements and build these into our processes
• Develop strong working relationships with both R&D and plant sites to ensure success
• Serves as a member of multidisciplinary product development teams responsible for the commercial scale development of new processes. He/she typically directs the laboratory activities and development of one or more junior staff members
• Participate in the Science Lead Team‚Äì part of scientific governance/oversight for Lilly sites.
• Provide technical oversight to the Post Launch Optimization Team (PLOT) and other relevant TS/MS technical projects. Be the technical steward on all products they are accountable for.
• Define and lead TS/MS technical projects (experimental, modelling and/or production data analysis) to improve process control, yield, purity and/or productivity.
• The Research Scientist/Senior Research Scientist should also have a proven track record in the following areas:
  • Demonstrated ability to commercialize and solve manufacturing problems.
  • Hands on experience supporting production at different scales from both a commercialization and supply perspective.
  • Proven track record of working with diverse groups across the value chain and in multiple locations
  • Understanding the interaction of bulk drug substance and drug product formulation interaction of equipment set(s) with process (drug substance and drug product)
  • Significant experience with registration, including authoring of technical reports, Development History Report, regulatory responses, or direct interactions with regulatory agencies.

Qualifications

• BSc/MSc/PhD in Chemistry/Biochemistry or related science discipline.
• BSc requires 10+ years of industrial experience. MSc/PhD requires 5+ years of industrial experience.
• Deep technical interest and understanding in manufacturing operational excellence principles.

Additional Skills

• Excellent verbal and written communications skills.
• Strong analytical and problem-solving skills.
• Collaborative skills with operations, automation, and other process team members.
• Ability to coach others.
• Ability to influence without authority.
• Ability to clarify and simplify complex issues.
• Strong trust building with peers and leaders.
• Willing to work off-shift hours as needed to support project milestones and training of new employees.

Education

• Not specified beyond degree requirements in Chemistry/Biochemistry or related science.

Additional Requirements

• The ADN RAMP team support across US and OUS sites; significant travel may be required to startup sites and potential short-term assignments across the network, including international relocations. Candidates must be mobile and flexible.