Sr Manager TS/MS RLT

Lilly; Indianapolis (IN); On-site; USD 101,000 - 147,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Job summary

Lilly's Radioligand Therapies Manufacturing site is seeking a Senior Manager TS/MS RLT to lead a team of scientists and engineers. You will guide process development, optimization, and scale-up for RLT products, drive technology transfer, and ensure compliant manufacturing processes with robust monitoring and CAPA programs.

The role emphasizes leadership, cross-functional collaboration, and governance in a regulated biopharmaceutical setting, with focus on quality, safety, and continuous

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 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.

Responsibilities

• Lead and manage a team of scientists and engineers, fostering high performance and collaboration.
• Provide technical leadership for process development, optimization, and scale-up for RLT products.
• Oversee transfer of new processes and technologies, ensuring validation.
• Develop strategies for process monitoring, data analysis, and SPC to ensure product quality and yield.
• Lead investigations into manufacturing deviations and CAPAs.

Skills

Leadership experience

cGMP knowledge

Process development

Scale-up & tech transfer

Education

Bachelor’s degree in Chemical Engineering, Biotechnology, Biochemistry, or related field

Job description

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 skills, with the ability to influence and collaborate effectively across all levels of the organization.

• Experience in RLT is highly desirable.

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$100,500 - $147,400

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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