- Proactively manage day-to-day business. This includes interactions with project leaders, hiring/staffing for future state, integration of technical personnel, oversite of planning, development, and coordination of activities to set up testing for sterility, endotoxin, bioburden, micro-biological identification, particulate matter, and environmental monitoring in the QC Micro lab.
- Once the lab is functional, manage day-to-day business by interacting with production planners, sample submitters, , 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 subject matter expert for internal and external audits.
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.Basic Experience Requirements:
- 7+ years' experience leading and developing people
- Teamwork and interpersonal skills
- Strong verbal and written communication skills
- Deep understanding of compliance requirements and regulatory expectations
- Knowledge and experience with laboratory testing techniques practices in support of testing for endotoxin, bioburden, sterility, utilities support, as well as an understanding of aseptic techniques, and environmental monitoring
- Ability to focus on continuous improvement.Education Requirements:
- Bachelor or Masters in a science or engineering discipline (Microbiology, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.)Additional Skills/Preferences:
- Effective time management
- Effective problem-solving skillsOther Information:
- 8 hour days – Monday through Friday
- Required to carry a mobile phone off shift and respond to operational issues.
- Minimal travel required.
- Ability to work in various areas within the site. Some allergens are present in the parenteral plant.
- Tasks may require repetitive motion (e.g., keyboarding). Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively "Lilly") are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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. #WeAreLilly -
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Microbiology Sr. Manager - Concord, United States - Eli Lilly and Company
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.
Company 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 39,000 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. #WeAreLilly
Organization Overview:
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.
Position Brand Description:
A laboratory Microbiology Testing Manager provides direction and/or conducts an area's daily workload planning, compliance, and overall customer service. The Microbiology Testing Manager must be committed to personnel interactions and will spend considerable time as a mentor/coach of reporting staff. The Manager also is responsible for coordinating laboratory analyst's performance planning. This role will be integral in designing and creating procedures and systems for the startup of the QC biological testing, utilities sampling/testing, and environmental monitoring labs at the site.
Key Objectives/Deliverables:
