Quality Control Manager

Responsibilities

• Run test method transfer/qualification/validation for GMP methods at contract laboratories to support Drug Substance and Drug Product in-process, release, and stability testing.
• Review and approve method qualification protocols, reports, and test methods.
• Review and approval of all data related to method transfer, qualification, and validation.
• Handle qualification, implementation, and inventory monitoring of reference standards, controls, and critical reagents.
• Manage establishment of method performance trending spreadsheets and once implemented, lead continuous monitoring activities.
• Work with other functional groups (e.g., Quality Assurance, Technical Operations, Process Development and Regulatory Affairs) to author QC SOPs, protocols, and reports.
• Manage cGMP testing (in-process, release, stability) at CDMOs and contract laboratories.
• Lead day-to-day Quality Control Operations at external partners.
• Lead laboratory investigations, deviations, change controls, CAPAs and risk assessments.
• Run the review and approval of Quality Control data and CoA/CoTs.
• Handle material specifications for excipients, drug substances and drug products.
• Handle the shipment of quality control samples from/to CDMOs and contract laboratories.
• Coordinate stability sample storage and testing per approved protocols.
• Other duties as assigned

Minimum Requirements

• BS Degree in a scientific or related field with 4+ years of experience in a biotechnology or pharmaceutical company.

OR

• MS Degree in a scientific or related field with 1+ year of experience in a biotechnology or pharmaceutical company.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Preferences

• JMP, SLIM. and/or Veeva experience preferred.
• Strong organizational skills and attention to detail.
• Strong writing, communication, and interpersonal skills.
• Ability to collaborate and work in a cross-functional environment.
• Proficiency in Microsoft Word and Excel.

Additional information

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 $72,000 - $169,400

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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