Sr. Principal Associate, Flow Mentor, Manufacturing Quality Assurance - Lilly Medicine Foundry

Responsibilities

• 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.

Requirements

• 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.
• Strong understanding of GMP requirements for early phase API development and manufacturing and application of quality management systems.

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences

• Experience in API manufacturing small and/or large molecules and/or high potent antibody drug conjugates (ADC).
• Experience with applicable equipment cleaning requirements.
• Relevant industry experience in high paced working environment.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.
• Proven experience in identifying innovative processes and implementing them with a focus on quality and acceleration.

Other Information

• Initial location at Parkwood West, Indianapolis, Indiana.
• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.
• Travel Percentage: 5% - 15%.
• May be required to provide on-call support outside of normal working hours including nights, weekends, and holidays.