Senior Principal Associate, Molecule Process Quality - Lilly Medicine Foundry

Role Summary

Senior Principal Associate, Small Molecule Process Quality at Lilly Medicine Foundry. You will provide on-site quality oversight of GMP operations during startup and in steady-state operations, ensuring compliance with early-phase GMP requirements and enabling cross-functional collaboration to deliver safe, high-quality drug substances produced by organic synthesis.

• Participate in creating and maintaining a safe work environment including leading/enabling safety efforts for the Quality team.
• Support cross-functional teams, facilitate decision making and drive progress.
• Support the execution of the site operational readiness plan including development of early phase quality processes and operational procedures and controls.
• Foster a strong collaborative quality culture including maintaining open communications and promoting teamwork and employee participation in the work group and with cross-functional teams.
• Ensure compliance with applicable laws, regulations, and guidelines to support early phase GMP activities.
• Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
• Work cross-functionally with the plant teams to develop processes, provide operational support, and issue management.
• Assist with inspection readiness activities.
• Facilitate decision making within the team under tight deadlines.
• Effectively communicate with internal and external stakeholders.
• Participate in global communities of practice and committees, as appropriate, to establish and maintain a network for benchmarking and share learning.
• Identify and lead process improvement projects impacting multiple business areas.

• Required: BA/BS degree in Engineering, Science, or related field with a minimum of 5 years technical and/or quality experience in Biotech or Pharmaceutical FDA-regulated industry.
• Required: Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.
• Required: Authorized to work in the United States on a full-time basis. Lilly will not provide sponsorship for work authorization or visas for this role.
• Preferred: Experience in API manufacturing of synthetic small molecules and/or high potency antibody drug conjugates (ADC).
• Preferred: Experience with applicable equipment cleaning requirements.
• Preferred: Relevant industry experience in a high-paced working environment.
• Preferred: Proven experience identifying innovative processes and implementing them with a focus on quality and acceleration.
• Preferred: Demonstrated strong oral and written communication skills.
• Preferred: Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting.
• Preferred: Flexibility to adjust quickly to frequent changes and altered priorities.
• Preferred: Ability to input and influence decision making for complex technical issues.
• Preferred: Ability to establish key relationships and influence peers and business partners.
• Preferred: Ability to identify and prioritize issues and develop and implement solutions.
• Preferred: High learning agility and ability to deal with ambiguity and uncertainty.
• Preferred: Demonstrated attention to detail.

• Quality management systems
• Regulatory/compliance awareness (GMP, early-phase API development)
• Cross-functional collaboration and stakeholder communication
• Process improvement and project leadership
• Root cause analysis and troubleshooting

• BA/BS degree in Engineering, Science, or related field

• Position Location:
  
  US:
  Lebanon IN Lilly Medicine Foundry Operations; initial location in Indianapolis, IN during startup phase
• Travel Percentage: 5% - 15%
• May be required to provide on-call support outside of normal working hours including nights, weekends, and holidays.