Sr. Manager - Quality Control - Microbiology and Environmental Monitoring

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Job description

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.

Sr. Manager - Quality Control - Microbiology and Environmental Monitoring provides direction and/or conducts an area's daily workload planning, compliance, and overall customer service. The Sr. Manager must be committed to personnel interactions (approachable), and will spend considerable time as a mentor/supporter of reporting staff. The Sr. Manager also is responsible for coordinating laboratory analysts' performance planning. This role will be integral in designing and installing procedures and systems for the startup of the QC biological testing and environmental monitoring labs at the site.

Key Objectives/Deliverables:

• Proactively manage day-to-day business. This includes interactions with project leaders, integration personnel, technical personnel and management to plan, develop, and coordinate activities to set up testing for sterility, endotoxins, bioburden, micro-biological identification, particulate matter, and environmental monitoring in the QC lab.
• Once the lab is functional, manage day-to-day business by interacting with production planners, sample submitters, et.al, to manage laboratory workload and throughput.
• Maintain a high-level understanding of the laboratory processes, and be responsible for analyst training on laboratory methods and proper sample handling.
• Develop career plans for laboratory analysts.
• Enforce compliance to all procedures, methods, and other regulatory commitments.
• Provide technical understanding of the regulations applicable to laboratory testing for cGMP purposes.
• Serve as a team change agent; safety agent.
• Participate as primary laboratory contact for internal and external audits
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Minimum Requirements:

• Bachelor (4 year college) degree in Chemistry/Biology/Microbiology
• 5 years of demonstrated experience in a GMP biological testing or EM laboratory.

Additional Preferences:

• Teamwork and interpersonal skills
• Strong verbal and written communication skills
• Deep understanding of compliance requirements and regulatory expectations
• Ability to focus on continuous improvement.
• Effective time management
• Effective problem solving skills

Additional Information:

• 8 hour days - Monday through Friday
• Required to carry a mobile phone off shift and respond to operational issues.
• Minimal travel required.
• Applicant will work in various areas within the site. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
• Tasks may require repetitive motion (e.g., keyboarding).
• Post-offer testing exam may be 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 ( ) 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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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