BioSpace
Sr. Director Process Translation & Execution, Clinical Trial API Manufacturing -
BioSpace, 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 give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now. The Senior Director, Process Translation and Execution is directly responsible for managing the site Process Translation and Execution function for the Lilly Medicine Foundry, our new, state-of-the-art Clinical Trial API Manufacturing pilot plant. This facility will support across small molecule, hybrid and biologics operations with onsite lab capabilities. The Senior Director Process Translation & Execution will provide technical, scientific and administrative leadership, ensuring the necessary capacity, capability and leadership structures are in place to execute and deliver the Foundry mission. This role reports to the Foundry Site Head and is a member of the Foundry Site Lead Team (FLT). The FLT develops and implements the strategic direction, organizational capability and management of the site. Members drive the site toward long-term business objectives, continuously develop the business and organization, and manage issues spanning multiple teams and the broader context. In the Project Delivery and Startup Phases (2025–2028), the FLT roles will be fluid and dynamic to support project delivery, build a new organization, and implement systems and processes for GMP operations, culture development, and steady-state operations. Responsibilities
Provide leadership for the Foundry site technical agenda. Contribute to developing 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 determine potential new products or business opportunities. Manage 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 for toxicology studies). Responsibilities include batch record creation/closeout, process familiarization/definitive lab trial demonstrations prior to scale-up, deviation investigation/management and campaign summaries. Develop/maintain the Foundry’s cleaning strategy and related metrics. Participate in development of strategic and operational plans and execute them within direct responsibility. Build strong technical and business relationships with CMC organizations and partnering manufacturing organizations. Partner with CMOs for in/out transfer of information and materials with other internal CMC/Foundry groups. Participate in all key strategic decisions for the Foundry from planning and execution perspectives. Ensure all small molecule, hybrid and biologics processes are maintained in a validated state meeting cGMP and regulatory requirements. Ensure technical documents are up to date and technical reports are completed on schedule and to standard. Provide necessary resources and facilities to the Process Translation and Execution team to perform their function. Coach and mentor others in leadership, technical insight, and business acumen; develop training, performance management, and career plans. 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 small molecule development and operations is a significant plus Knowledge of cGMPs and how they apply to operations Effective communication skills across all levels of the organization Strong interpersonal and teambuilding abilities; coaching and feedback skills Results-oriented with bias for action Analytical and conceptual problem-solving skills Excellent self-management and organizational skills; ability to manage multiple priorities and adapt to changing conditions Ability to frame decisions and execute on them Ability to influence stakeholders without direct authority and negotiate effectively High learning agility and comfort with ambiguity Other Information
Initial location at Lilly Technology Center, Indianapolis; permanent location at the Lilly Medicines Foundry in Lebanon, Indiana Lilly is an EEO/AA Employer and does not discriminate on age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status Actual compensation depends on education, experience, skills, and location. The anticipated wage for this position is $151,500 - $222,200. Full-time employees are eligible for a company bonus and comprehensive benefits
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Find out more about the daily tasks, overall responsibilities, and required experience for this opportunity by scrolling down now. The Senior Director, Process Translation and Execution is directly responsible for managing the site Process Translation and Execution function for the Lilly Medicine Foundry, our new, state-of-the-art Clinical Trial API Manufacturing pilot plant. This facility will support across small molecule, hybrid and biologics operations with onsite lab capabilities. The Senior Director Process Translation & Execution will provide technical, scientific and administrative leadership, ensuring the necessary capacity, capability and leadership structures are in place to execute and deliver the Foundry mission. This role reports to the Foundry Site Head and is a member of the Foundry Site Lead Team (FLT). The FLT develops and implements the strategic direction, organizational capability and management of the site. Members drive the site toward long-term business objectives, continuously develop the business and organization, and manage issues spanning multiple teams and the broader context. In the Project Delivery and Startup Phases (2025–2028), the FLT roles will be fluid and dynamic to support project delivery, build a new organization, and implement systems and processes for GMP operations, culture development, and steady-state operations. Responsibilities
Provide leadership for the Foundry site technical agenda. Contribute to developing 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 determine potential new products or business opportunities. Manage 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 for toxicology studies). Responsibilities include batch record creation/closeout, process familiarization/definitive lab trial demonstrations prior to scale-up, deviation investigation/management and campaign summaries. Develop/maintain the Foundry’s cleaning strategy and related metrics. Participate in development of strategic and operational plans and execute them within direct responsibility. Build strong technical and business relationships with CMC organizations and partnering manufacturing organizations. Partner with CMOs for in/out transfer of information and materials with other internal CMC/Foundry groups. Participate in all key strategic decisions for the Foundry from planning and execution perspectives. Ensure all small molecule, hybrid and biologics processes are maintained in a validated state meeting cGMP and regulatory requirements. Ensure technical documents are up to date and technical reports are completed on schedule and to standard. Provide necessary resources and facilities to the Process Translation and Execution team to perform their function. Coach and mentor others in leadership, technical insight, and business acumen; develop training, performance management, and career plans. 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 small molecule development and operations is a significant plus Knowledge of cGMPs and how they apply to operations Effective communication skills across all levels of the organization Strong interpersonal and teambuilding abilities; coaching and feedback skills Results-oriented with bias for action Analytical and conceptual problem-solving skills Excellent self-management and organizational skills; ability to manage multiple priorities and adapt to changing conditions Ability to frame decisions and execute on them Ability to influence stakeholders without direct authority and negotiate effectively High learning agility and comfort with ambiguity Other Information
Initial location at Lilly Technology Center, Indianapolis; permanent location at the Lilly Medicines Foundry in Lebanon, Indiana Lilly is an EEO/AA Employer and does not discriminate on age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status Actual compensation depends on education, experience, skills, and location. The anticipated wage for this position is $151,500 - $222,200. Full-time employees are eligible for a company bonus and comprehensive benefits
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