Sr Manager TS/MS RLT

Eli Lilly and Company•Us, IN

About The Position

The Senior Manager TS/MS RLT leads the team responsible for technical services and manufacturing science at a Radioligand Therapies Manufacturing site. The role provides scientific leadership to establish robust, compliant, well-designed, controlled, and validated processes for the safe manufacture of high-quality medicines. It involves leading and mentoring technical staff, applying knowledge of RLT aseptic processing and drug product manufacturing, and managing routine production support while balancing technical projects and process optimization. The position oversees the site’s process control strategy, validation, technical and commercialization agenda, and technical transfer of new products. It also provides governance for the site’s technical and scientific agenda, supports process stewardship for existing and new products, and collaborates with CMC to define and improve manufacturing control strategies. The role contributes to site leadership and governance activities, promotes an inclusive and engaged workforce, and helps ensure audit and inspection readiness and timely closure of regulatory commitments. Lilly describes its work as focused on discovering and delivering life-changing medicines and improving health and communities. The company is headquartered in Indianapolis, Indiana, and has more than 50,000 employees around the globe. The anticipated wage is $100,500–$147,400. Full-time equivalent employees are eligible for a company bonus, subject in part to company and individual performance, and eligible employees may participate in the company’s benefits program.

Requirements

  • Bachelor’s degree in Chemical Engineering, Biotechnology, Biochemistry, or a related scientific discipline.
  • At least 5 years of experience in a technical services, manufacturing science, or process development role in the pharmaceutical industry.
  • At least 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 technology transfer.
  • Proficiency in statistical process control (SPC) and data-analysis tools.
  • Strong problem-solving, analytical, and critical-thinking skills.
  • Strong leadership, communication, and interpersonal skills, with the ability to influence and collaborate effectively across organizational levels.

Nice To Haves

  • Experience in radioligand therapies (RLT) is highly desirable.

Responsibilities

  • Lead and manage scientists and engineers, fostering high performance, collaboration, and continuous improvement.
  • Provide technical expertise and leadership for process development, optimization, and scale-up for RLT products.
  • Oversee transfer of new processes and technologies, including successful implementation and validation.
  • Develop and implement process-monitoring, data-analysis, and statistical process-control strategies to support consistent product quality and yield.
  • Lead investigations into manufacturing deviations, process failures, and product quality issues, and implement corrective and preventive actions.
  • Ensure compliance with cGMP regulations, internal quality standards, and industry best practices.
  • Mentor and develop team members, including guidance on career progression and technical skills.
  • Represent the TS/MS RLT function in internal meetings and present technical data and strategic initiatives.
  • Manage budgets and resources for TS/MS RLT activities.
  • Foster an inclusive workplace and an engaged workforce.
  • Participate in the Site Lead Team, functional lead teams, and other appropriate site governance groups.
  • Provide leadership and governance for the site’s technical and scientific agenda through the Science Lead Team, including process monitoring.
  • Ensure appropriately trained and qualified staff are available for day-to-day process stewardship and project support for new and existing products.
  • Ensure effective process monitoring to continually improve control strategies, reduce risk, maintain the validated state, and support manufacturing productivity.
  • Technically review and approve site quality documents, plans, and studies.
  • Collaborate with CMC to define, implement, and improve control strategies for manufacturing processes at the CORE site.
  • Ensure audit and inspection readiness and timely closure of regulatory commitments within TS/MS areas of responsibility.
  • Provide technical support during regulatory inspections and submissions, partner audits, and internal audits.

Benefits

  • Company bonus for eligible full-time equivalent employees, depending in part on company and individual performance.
  • Company-sponsored 401(k) participation eligibility.
  • Pension.
  • Vacation benefits.
  • Medical, dental, vision, and prescription drug benefits eligibility.
  • Flexible benefits, including healthcare and/or dependent day-care flexible spending accounts.
  • Life insurance and death benefits.
  • Certain time-off and leave-of-absence benefits.
  • Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
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