Eli Lilly and Company
Sr. Director Process Translation & Execution, Clinical Trial API Manufacturing -
Eli Lilly and Company, Lebanon, Indiana, United States, 46052
Overview
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and contribute to communities through philanthropy and volunteerism. We are seeking a Sr. Director, Process Translation & Execution, Clinical Trial API Manufacturing to lead the Foundry site technical agenda and ensure GMP-compliant operation of the Clinical Trial API manufacturing pilot plant. Responsibilities
Provide leadership for the Foundry site technical agenda. Help develop the strategic direction for the site in the medium and long term. Develop future technical leadership for the site and for potential assignments across Product Research & Development (CMC) and manufacturing. Collaborate with leaders to identify potential new products or business opportunities. Oversee all aspects of the Process Translation & Execution function including transfer in of new projects, translation and execution of processes to produce API for clinical trials (and possibly non-GMP purposes such as toxicology studies). Manage batch record creation/close-out, process familiarization/definitive lab trial demonstrations prior to plant scale-up, deviation investigation/management, and campaign summaries. Develop and maintain the Foundry’s cleaning strategy and related metrics. Participate in the development of strategic and operational plans and execute them within areas of responsibility. Build technical and business relationships with CMC organizations and partner manufacturing organizations. Collaborate with internal CMC/Foundry groups and CMOs for transfer of information and materials. Participate in key strategic decisions for the Foundry from planning and execution perspectives. Ensure small molecule, hybrid and biologics processes are maintained in a validated state meeting all applicable cGMP and regulatory requirements. Ensure technical documents are up to date and technical reports are completed on schedule and to standard. Provide the necessary resources and facilities to the Process Translation and Execution team to carry out their function. Coach and mentor others in leadership, business, and technical areas; develop training, performance management, and career plans for team members. Basic Requirements
PhD or MS in Chemistry/Biochemistry/Biochemical Engineering Minimum of eight years of drug substance development or TS/MS (MSAT) in a Clinical Trial API manufacturing setting; at least 3+ years of leading scientists/engineers. Additional Preferences
Pilot plan experience in support of small molecule development and operations is a significant plus Knowledge and understanding of cGMPs and how they apply to operations Effective communication skills with the ability to interact with all levels of the organization Strong interpersonal and teambuilding skills; ability to coach and provide feedback and develop team members Outcome-focused with bias for action and results Strong analytical and conceptual problem-solving skills Excellent self-management and organizational skills; able to manage multiple priorities and adapt to changing situations Ability to frame and execute decisions and influence stakeholders without direct authority High learning agility and comfort with ambiguity Other Information
Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Compensation and Benefits
Actual compensation will depend on education, experience, skills, and location. Anticipated base salary: $151,500 - $222,200. Full-time employees may be eligible for a company bonus. Lilly offers a comprehensive benefits program including 401(k), pension, medical/dental/vision, flexible spending accounts, life insurance, leave benefits, and well-being programs.
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At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and contribute to communities through philanthropy and volunteerism. We are seeking a Sr. Director, Process Translation & Execution, Clinical Trial API Manufacturing to lead the Foundry site technical agenda and ensure GMP-compliant operation of the Clinical Trial API manufacturing pilot plant. Responsibilities
Provide leadership for the Foundry site technical agenda. Help develop the strategic direction for the site in the medium and long term. Develop future technical leadership for the site and for potential assignments across Product Research & Development (CMC) and manufacturing. Collaborate with leaders to identify potential new products or business opportunities. Oversee all aspects of the Process Translation & Execution function including transfer in of new projects, translation and execution of processes to produce API for clinical trials (and possibly non-GMP purposes such as toxicology studies). Manage batch record creation/close-out, process familiarization/definitive lab trial demonstrations prior to plant scale-up, deviation investigation/management, and campaign summaries. Develop and maintain the Foundry’s cleaning strategy and related metrics. Participate in the development of strategic and operational plans and execute them within areas of responsibility. Build technical and business relationships with CMC organizations and partner manufacturing organizations. Collaborate with internal CMC/Foundry groups and CMOs for transfer of information and materials. Participate in key strategic decisions for the Foundry from planning and execution perspectives. Ensure small molecule, hybrid and biologics processes are maintained in a validated state meeting all applicable cGMP and regulatory requirements. Ensure technical documents are up to date and technical reports are completed on schedule and to standard. Provide the necessary resources and facilities to the Process Translation and Execution team to carry out their function. Coach and mentor others in leadership, business, and technical areas; develop training, performance management, and career plans for team members. Basic Requirements
PhD or MS in Chemistry/Biochemistry/Biochemical Engineering Minimum of eight years of drug substance development or TS/MS (MSAT) in a Clinical Trial API manufacturing setting; at least 3+ years of leading scientists/engineers. Additional Preferences
Pilot plan experience in support of small molecule development and operations is a significant plus Knowledge and understanding of cGMPs and how they apply to operations Effective communication skills with the ability to interact with all levels of the organization Strong interpersonal and teambuilding skills; ability to coach and provide feedback and develop team members Outcome-focused with bias for action and results Strong analytical and conceptual problem-solving skills Excellent self-management and organizational skills; able to manage multiple priorities and adapt to changing situations Ability to frame and execute decisions and influence stakeholders without direct authority High learning agility and comfort with ambiguity Other Information
Initial location at Lilly Technology Center, Indianapolis. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Compensation and Benefits
Actual compensation will depend on education, experience, skills, and location. Anticipated base salary: $151,500 - $222,200. Full-time employees may be eligible for a company bonus. Lilly offers a comprehensive benefits program including 401(k), pension, medical/dental/vision, flexible spending accounts, life insurance, leave benefits, and well-being programs.
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