Senior Principal Associate, Small Molecule Process Quality - Lilly Medicine Foun
Scorpion Therapeutics, Lebanon, Indiana, United States, 46052
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. 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. Qualifications
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. Skills
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 Education
BA/BS degree in Engineering, Science, or related field Additional Requirements
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.
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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. 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. Qualifications
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. Skills
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 Education
BA/BS degree in Engineering, Science, or related field Additional Requirements
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.
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