- 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 qualification activities for laboratory equipment and implementation of laboratory systems (ex. LIMS, MODA, etc.).
- Once the lab is functional, manage day-to-day business by supporting QC Laboratory testing labs with equipment qualification, lifecycle maintenance, maintenance programs/activities, and ongoing support for laboratory software systems.
- Maintain a high-level understanding of the laboratory qualification process, lifecycle management, and laboratory software systems.
- Follow up on excursions and deviations related to analytical instruments.
- Oversee management of vendors performing maintenance activities on analytical instruments.
- Develop career plans for laboratory analysts.
- Enforce compliance to all procedures, methods, and other regulatory commitments.
- 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.
- Teamwork and interpersonal skills
- Strong verbal and written communication skills
- Deep understanding of compliance requirements and regulatory expectations
- Familiarity with laboratory equipment to support Chemistry and Microbiology.
- Familiarity with LIMS, MODA, and Empower.
- Minimum 7+ years of related experience in regulated environment.
- Knowledge related to instrument qualification, data integrity, and regulatory guidance such as FDA CFR 21 Part 11, Annex 11, etc.
- Bachelor or Masters in a science or engineering discipline (Chemistry, Biology, Mechanical Engineering, Biomedical Engineering, etc.)
- Effective time management
- Effective problem-solving skills
- Experience with electronic qualification (KNEAT).
- Demonstrated written and oral communication skills and ability to collaborate and interact with management, scientists, engineering, and IT personnel.
- Ability to manage and contribute to multiple concurrent project activities and adapt to changes in priorities.
- 8 hour days – Monday through Friday
- Required to carry a mobile phone off shift and respond to operational issues.
- Travel may be required during project phase.
- 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).
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Sr. Manager - Concord, United States - Eli Lilly
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:
The QC Laboratory Support Team Leader provides direction and/or conducts an area's daily workload planning, compliance, and overall customer service. The Team Leader must be committed to personnel interactions (approachable) and will spend considerable time as a mentor/supporter of reporting staff. The Team Leader 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 lab at the site.
Key Objectives/Deliverables:
Basic Experience Requirements:
Education Requirements:
Additional Skills/Preferences:
Other Information:
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
