Associate Director - Technical Services/Manufacturing Science, Indy RLT

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 Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

This role is at the Indy - RLT facility. The Indy - RLT is Lilly's Center of Radioligand Excellence responsible for the Commercial launch of RLTs, Supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches.

Responsibilities:

The Assoc. Director of TS/MS enables Operational Excellence by ensuring strong scientific leadership for the site and establishing processes that are well designed, in control, and validated to for making high quality medicine safely. is responsible for leading/mentoring technical staff and understanding RLT aseptic processing as it relates to drug product manufacturing. This includes managing routine production support activities while balancing implementation of technical projects and process optimizations.

The scope of responsibilities includes process control strategy, validation, and the technical and commercialization agenda.

Team and Personnel Development:

• Leading, developing, coaching and mentoring an organization of scientists and technical resources to ensure technical depth within the Site.
• Fostering an inclusive workplace and engaged workforce.
• Ensuring effective hiring and staffing (right person for the right role).

Plant Leadership:

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Support the development of site business and strategic plan and oversee execution to ensure goals are met
• Participate actively on the Site Lead Team, functional lead teams, and other governance instances at the site (as appropriate).
• Provide leadership and governance to the technical/scientific agenda for the site via the Science Lead Team (process monitoring).
• Represent the TS/MS organization in various governance forums within the site (i.e., DRB/CRB, Operational Flow Teams)
• Provide leadership and governance to the site commercialization agenda via the Commercialization Lead Team ensuring alignment and communication with CMC and Oncology Business Unit.
• Benchmark and network with other Lilly sites and PR&D for communications and shared learning (best practices, learnings, etc.)

Functional Oversight:

• Assure that appropriately trained and qualified staff are in place to provide process stewardship day to day support and project support for new and existing products.
• Ensure effective process monitoring for continuous improvement of control strategy, risk reduction, maintenance of the validated state and for manufacturing productivity.
• Influence and implement the technical and commercialization agenda within a multi-discipline technical environment.
• Exhibit critical business decision making taking into consideration quality, compliance, and business aspects, escalate critical quality issues, when appropriate, on a timely manner, and proposing decisions into the escalation forum (e.g., Site Lead Team)
• Technical review and approval for site quality documents, plans, and studies.
• Provide guidance on major investigations ensuring sound technical rationale and robust root cause analysis
• Ensure processes are validated and in-control and capable of producing high quality medicine.
• Collaborate with CMC to define, implement and improve control strategies for all manufacturing processes at the CORE site.
• Ensure audit and inspection readiness and assure timely closure of all regulatory commitments related to TS/MS areas of responsibility.
• Provide technical support during regulatory inspections and submissions, as well as partner and internal audits.

Basic Requirements:

• Bachelors’ Degree or equivalent in scientific disciplines of Chemistry, Microbiology, Pharmacy, or Engineering.
• 5 years of cGMP manufacturing experience

Previous experience preferred:

• Technical management or leadership experience including leading cross functional group
• Radioligand Therapeutics
• Parenteral drug product manufacturing
• Equipment qualification and process validation
• Commercialization and technical transfer

Additional Skills/Preferences:

• Strategic thinking and ability to balance short term needs with long term business evolution to prioritize efforts.
• Ability to influence and communicate to diverse groups on complex regulatory, business, or technical issues within the site and function.
• Technical writing and communication skills are used daily and the ability to effectively communicate and transfer knowledge to all levels of the organization is essential.
• Proficiency in delivering highly complex tasks and / or tasks that are highly cross-functional.
• Strong analytical and quantitative problem-solving skills with experience in root cause analysis
• Proficient in root cause analysis methodology and tools.
• Thorough technical understanding of the quality systems and regulatory requirements.

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

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.

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