Sr. Director Process Translation & Execution, Clinical Trial API Manufacturing – Lilly Medicine Full Time on the ground

Job Details

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 around the world 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.

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 around the world 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.

Organization and Position Overview

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

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 be responsible for providing technical, scientific and administrative leadership, ensuring the necessary capacity, capability and leadership structures are in place to execute and deliver the mission of the Foundry.

This role will report to the Foundry Site Head and is a member of the Foundry Site Lead Team (FLT). The FLT has collective responsibility to develop and implement the strategic direction, organizational capability and management of the site. Primarily, the members of the team drive the site toward achieving long term business objectives; they continuously develop the business and the organization for the future bearing in mind corporate and LRL objectives and the continuously changing external environment; and they manage issues that span multiple teams in the organization and extend into the broader corporate and external context.

In the Project Delivery Phase and Startup Phase of the project (2025 To 2028), the FLT roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations and build the site culture. This will require significant collaboration, creativity and resilience as the Lilly Medicines Foundry goes from design, to start-up, and to steady-state operations.

Responsibilities

• Provide leadership for the Foundry site technical agenda.

• Key participant in developing the strategic direction for the site on both the medium and the long term.

• Develop the future technical leadership for the site and for potential assignments across Product Research & Development (CMC) and manufacturing.

• Works closely with leaders to determine potential new products or business.

• Responsible for 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 for non-GMP purposes such as toxicology studies). This will include batch record creation/close out, process familiarization/definitive lab trial demonstration prior to plant scale-up, deviation investigation/management and campaign summaries.

• Develops/maintains Foundry’s cleaning strategy and associated metrics.

• Participates in the development of the strategic and operational plans for the site and is responsible for the execution of these plans in their areas of direct responsibility.

• Build strong technical and business relationships with CMC organizations, as well as partnering manufacturing organizations.

• Working with other internal CMC/Foundry groups, responsible for partnering with CMOs for in/out transfer of information and materials.

• Participates in all key strategic decisions for the Foundry from a planning and execution point of view.

• Ensure that all small molecule, hybrid and biologics processes are maintained in a validated state meeting all applicable cGMP and regulatory requirements.

• Ensure that all required technical documents are up to date and that all technical reports are completed on schedule and to an appropriate standard.

• Responsible for ensuring that the necessary resources and facilities are provided to the Process Translation and Execution team to allow them to carry out their function.

• Coach and mentor others in all aspects of leadership, business and technical insight.

• Works with team members to develop and maintain their 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. Must have minimum of 3+ years of leading scientists/engineers.

Additional Preferences:

• Pilot Plan experience in support of small molecule development and operations is a significant plus
• Must possess knowledge and understanding of cGMPs and how they apply to operations.

• Effective communication skills with the experience and maturity to interact with all levels of the broader organization

• Excellent interpersonal and teambuilding skills – able to develop effective teamwork between team members with diverse interpersonal styles; able to deliver effective coaching and feedback and develop team members.

• Outcomes focus: demonstrated bias for action and focus on results

• Demonstrated analytical and conceptual problem-solving skills

• Excellent self-management and organizational skills; able to manage multiple priorities, set personal and team priorities, and adjust as needed (ability to quickly adapt to changing situation, learn while doing, and deliver results)

• Excellent at framing decisions and executing on decisions.

• Excellent at influencing team members and internal/external stakeholders without direct positional authority and effective at negotiating agreements both internally and externally to the team.

• High learning agility – embraces ambiguity

Other Information:

• Initial location at Lilly Technology Center, Indianapolis.

• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 – $222,200

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

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