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 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.   

This role is at the Indianapolis RLT facility, formerly Point Biopharma.  The RLT manufacturing site is responsible for the Commercial launch of Radioligand Therapies (RLTs), Supply of late-stage investigational products, and scale-up/optimization for Ph3 and commercial launches.  

Responsibilities:

The Sr. Manager of TS/MS Sterility Assurance is responsible for leading/mentoring a technical staff in support of the site sterility assurance strategy and execution of the sterility assurance programs. The scope of responsibilities includes aseptic process support, EMPQ, Sterilization Validation, Aseptic Process Simulations, and contamination control. Key deliverables and objectives include:

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).

Sterility Assurance Oversight and Execution:

Ensure that appropriately trained and qualified staff are in place to provide sterility assurance day-to-day support and project support for new and existing products.Author, review, and/or approve site quality documents, plans, and studies.Use sterility assurance risk management to evaluate existing process and controls with respect to microbial, endotoxin and particulate contamination ingress.Provide input into procedures and work instructions related to execution of sterility assurance programs at the site including aseptic practices, gowning, sanitization, sterilization validation, EMPQ, and media fill.Provide oversight of the execution of site sterility assurance programs, ensuring compliance with program requirements.Identify and implement continuous improvement for sterility assurance programs.Author, review, or approve deviation investigations and root cause analysis related to sterility assurance programs.Create, review, approve and provide sterility assurance training for site personnel.Exhibit critical business decision making taking into consideration quality, compliance, and business aspects, escalate critical quality issues, when appropriate, in a timely manner, and propose decisions into the escalation forum (e.g., Site Lead Team)Ensure audit and inspection readiness and ensure timely closure of all regulatory commitments related to sterility assurance program execution.Provide support during regulatory inspections and submissions, as well as partner and internal audits.Maintain a safe work environment by working safely and supporting all HSE Corporate and Site Goals.

Basic Requirements:

Bachelor’s degree in microbiology, biology, or related scientific field.3+ years supporting cGMP pharmaceutical manufacturing with experience with sterile product and aseptic processes.

Additional Skills/Preferences:

Ability to work independently and with minimal supervision.Technical leadership capabilities, and the ability to train/coach others. Ability to influence and communicate to diverse groups on complex regulatory, business, or technical issues within the site and function.In depth knowledge and understanding of GMPs and internal standardsWorking knowledge of aseptic manufacturing practicesIn depth knowledge of microbiology and sterility assuranceWorking knowledge of risk management and the understanding / ability to use risk assessment toolsAbility to analyze complex data and solve problemsStrong technical writing and presentation skillsTeamwork / interpersonal skills ability to effectively influence

Additional Information:

Day Shift, possible off-shift support.Tasks require entering controlled areas where radioactive materials may be present. Special training and exposure monitoring are required.

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

$96,000 - $140,800

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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