Job Information
Lilly Associate Director-TS/MS Sterility Assurance Technology in Indianapolis, Indiana
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 35,000 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.
Organization Overview:
The Associate Director – Technical Services/Manufacturing Science (TS/MS) Sterility Assurance Technology (SAT) is responsible for leading a team and understanding elements of parenteral manufacturing, including the technical elements relative to the sterility assurance control strategy. Key position responsibility is to address technical challenges and provide guidance/coaching to a technical staff, assist in prioritization, address GMP compliance issues, and ensure implementation of SAT functional initiatives. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for sterility assurance. Influence and implement the technical agenda within a multi-discipline technical environment. Work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plan, and quality objectives.
Responsibilities:
Ensure site’s Environmental Monitoring, Aseptic Process Simulations, Facility Cleaning, Facility Sanitization, Sterility Assurance Risk Management and other sterility assurance programs are followed.
Technical and defendable process support service.
Performance management and development of staff.
Partner within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives and GMP Quality Plan objectives.
Technical review and approval for site quality documents, periodic reviews, aseptic process simulations, technical studies, deviations, change controls and SOPs.
Basic Requirements:
Bachelors in scientific disciplines of Microbiology, Biology, or other related science
Must have at least 3 years of experience. Applied micro or parenteral experience strongly preferred.
Additional Skills/Preferences:
Relevant Parenteral Manufacturing leadership experience (greater than 5 years) in any of the following associated disciplines such as Quality Control, Quality Assurance, Technical Services/Manufacturing Science, or Engineering is required.
Teamwork and interpersonal skills.
Technical leadership, administrative and organizational skills.
Problem solving and independent decision-making skills.
Multi-tasking and communication skills.
Ability to influence diverse groups
Computer and statistical analysis skills
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Additional Information:
8 hour days –Monday through Friday
Overtime will be required
Required to respond off shift to operational issues, as needed.
Minimal Travel required
Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
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