Advisor, 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 6 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.
• Qualified applicants must be authorized to work in the United States on a full-time basis.
• 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.
• Demonstrated strong oral and written communication skills.
• Critical thinking and technical problem-solving skills, including root cause analysis/troubleshooting skills.
• Flexibility to adjust quickly and effectively to frequent changes and altered priorities.
• Ability to input and influence decision making for complex technical issues.
• Ability to establish key relationships and influence peers and business partners.
• Ability to identify and prioritize issues and develop & implement solutions.
• High learning agility and ability to deal with ambiguity, uncertainty.
• Demonstrated attention to detail.
• For Internal Lilly employees -LRL/Product Research Development experience preferred.