Sr. Manager - Quality Control

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.

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. The Lilly CORE facility located in Indianapolis, IN, supports that purpose through the development and manufacture of Radioligand drug products for the treatment of cancer.  Radioligand Therapies represent a new technology in the treatment of cancer which reduces impact to surrounding tissues and offers great promise to patients.

Lilly CORE is currently searching for a Quality Control Laboratory Manager.  The Quality Control (QC) Manager ensures laboratory readiness to support scheduling and testing of samples/batches in a cGMP laboratory environment.  Testing consists of raw materials, clinical materials, and commercial batches using a variety of analytical instrumentation and techniques while performing administrative tasks such as personnel scheduling, training, routine documentation activities, and data review.

Laboratory readiness includes all elements of the operation, including personnel staffing, equipment availability, materials availability, staff performance development, and adherence to laboratory cGMP practices/procedures.   

Key Objectives

• Support daily manufacturing operations by coordinating and performing routine cGMP testing on samples utilizing a variety of chromatography methods, spectroscopy methods, and compendial wet chemistry testing, according to phase appropriate guidelines.
• Ensure all drug products are tested in accordance with the highest standards of Good Manufacturing Practice (GMP), in alignment with Lilly Global Quality Standards and local site SOPs.

Key Accountabilities

• Coordinate testing of starting materials, in-process, API, drug substance, and finished drug product.
• Schedule and ensure adequate coverage to meet scheduled routine testing requirements based on the site manufacturing schedule.
• Ensure adequate materials and instrumentation to meet scheduled workload.
• Oversee and coordinate third-party contract laboratories to ensure support for site projects and release testing Lead lab project and/or team meetings as appropriate.
• Train QC lab members on analytical methods, instruments, and lab software suites.
• Author Quality documentation, including deviations, laboratory investigations OOS/OOT Lab Investigations, Deviations, and CAPAs.  Author, review, and approve laboratory related change controls and risk assessments.
• Train on routine analyses utilizing the following instrumentation: UHPLC, ICP-MS, Gamma Spectrometry, TLC, Dose Calibrators, Endotoxin, Auto-titrators, FT-IR, pH meter, Karl Fischer, and other wet chemistry techniques.
• Ensure project timelines, key performance indicators and corporate goals are achieved, as related to routine quality control testing.
• Complete final review of data, specification sheets, and certificates of analysis, when applicable.
• Once qualified, perform technical (peer) review of data generated by the laboratory.
• Assist in instrument troubleshooting and simple maintenance tasks.
• Coordinate reactive and preventative maintenance with the third-party vendors.
• Compose and review SOPs, protocols, reports, forms, and certificates of analysis.
• Interact with auditors and regulatory inspectors.
• Mentor and develop direct reports.

Required Experience

• Bachelors in Science, Technology, Engineering, or Math (STEM)
• 5+ years of GMP pharmaceutical industry experience building or operating within defined business processes for scheduling and KPI monitoring

Additional Preferences

• Experience with GMP Quality systems, including investigations OOS, OOT, LIR, Deviations, Change Management etc… as well as protocol writing and execution.
• A foundational understanding and knowledge of analytical instrumentation technologies, chromatography methods, USP compendial test methods, ICH guidelines, and good manufacturing practices.
• Availability to support the testing activities of time-sensitive radiopharmaceuticals. This may require working off-hours as needed to support the manufacturing schedule.
• Previous experience as a supervisor or team leader.
• Familiarity with software already in use in the laboratory (e.g., Empower, Chromeleon, EndoScan,ApexGuard, Qtegra, LabX, LARA, etc.).
• Proven track record of establishing or maintaining robust business processes in a laboratory operation.

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

$91,500 - $134,200

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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