Sr Manager TS​/MS RLT

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

As a Senior Manager TS/MS RLT, you will lead a team responsible for technical services and manufacturing science within the Radioligand Therapies Manufacturing site (RLT), ensuring robust and compliant manufacturing processes.

Enables Operational Excellence by ensuring strong scientific leadership for the site and establishing processes that are well designed, in control, and validated for making high quality medicine safely. They are 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, the technical and commercialization agenda, and the technical transfer of new products to the site.

Responsibilities:

* Lead and manage a team of scientists and engineers, fostering a culture of high performance, collaboration, and continuous improvement.

* Provide technical expertise and leadership for process development, optimization, and scale-up activities for RLT products.

* Oversee the transfer of new processes and technologies, ensuring successful implementation and validation.

* Develop and implement strategies for process monitoring, data analysis, and statistical process control to ensure consistent product quality and yield.

* Lead investigations into manufacturing deviations, process failures, and product quality issues, implementing effective corrective and preventive actions (CAPAs).

* * Ensure compliance with cGMP regulations, internal quality standards, and industry best practices.

* Mentor and develop team members, providing guidance on career progression and technical skill enhancement.

* Represent the TS/MS RLT function in internal meetings, presenting technical data and strategic initiatives.

* Manage budget and resources effectively to support TS/MS RLT activities.

* Fostering an inclusive workplace and engaged workforce.

* 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).

* 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

* Technical review and approval for site quality documents, plans, and studies

* 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

Qualifications:

* Bachelor's degree in Chemical Engineering, Biotechnology, Biochemistry, or a related scientific discipline.

* Minimum of 5 years of experience in a technical services, manufacturing science, or process development role in Pharmaceutical industry.

* Minimum of 3 years of experience in a leadership or management role, leading technical teams.

* Strong understanding of cGMP regulations and regulatory requirements for biopharmaceutical manufacturing.

* Demonstrated experience in process development, scale-up, validation, and tech transfer.

* Proficiency in statistical process control (SPC) and data analysis tools.

* Excellent problem-solving, analytical, and critical thinking skills.

* Strong leadership, communication, and interpersonal…