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At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The Associate Director TS/MS – Sterility Assurance is responsible for the oversight of Sterility Assurance organizations supporting Lilly Kenosha County (LKC) parenteral manufacturing. The role is responsible for leading and mentoring a technical staff and understanding parenteral aseptic processing as it relates to drug product manufacturing, specifically the formulation/filling/inspection of pharmaceutical products. The Associate Director will provide guidance on time management and priorities for direct reports and manage routine production support activities while balancing implementation of technical projects and program oversight.

This position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate / industry standards related to sterility assurance. Additionally, this position requires the ability to multitask/prioritize, excellent written and oral communication skills, decision making ability, interpersonal skills, as well as the ability to anticipate potential problems then develop / implement solutions. This role is expected to work with peer leadership in a positive fashion to deliver on functional technical objectives, specific product business plan, and quality objectives.

Key Objectives/Deliverables:

• Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
• Technical and defendable contamination control strategy design and execution
• 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 GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
• Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance issues.
• Network internally and externally to understand best practices, share knowledge, participate in tactical and strategic business planning.
• Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.
• Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
• Use sterility assurance risk management to evaluate proposed manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination.
• Ensure site’s environmental monitoring, aseptic process simulations, facility cleaning, facility sanitization, sterility assurance risk management, and other sterility assurance programs are followed at the manufacturing floor level.
• Provide technical guidance to the Process Team for sterility assurance programs and for root cause investigations related to sterility assurance programs.
• Analyze microbial and manufacturing data using statistical principles to identify trends, process disruptions, and opportunities for continuous improvements.
• Define and maintain inspection readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs.

Basic Requirements:

• BS Degree required.
• MS/PhD in a biological science preferred
• 10+ years’ experience working in Parenteral Sterility Assurance/Environmental Monitoring or equivalent roles
• 10+ years' experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment
• Deep technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, Annex 1 interpretation)
• Minimum 3 years of management or leadership experience, including leading or working effectively with a cross functional group
• Teamwork and interpersonal skills
• Independent critical decision making, complex problem solving, and prioritization skills
• Multi-tasking and communications skills
• Ability to influence diverse groups

Additional Skills/Preferences:

• Proficiency in data analysis, ability to prioritize, attention to detail, critical decision-making skills, complex problem-solving abilities
• Strong written and oral communication skills
• Ability to mentor and develop scientists in the fields of sterility assurance and applied pharmaceutical microbiology
• Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance
• Demonstrated experience influencing site and network leaders to advance technical agenda projects
• Strength in scientific and practical thinking to ensure the best options are selected following a thorough evaluation of applicable options.
• Strong capability to influence personnel and management across the organization
• Additional relevant experience (greater than 5 years) in any of the following associated disciplines such as Aseptic Manufacturing, Quality Control, Quality Assurance, or Microbiological Laboratories
• Experience with syringe technology and isolator filling technology

Additional Information:

• Role is Monday through Friday based.  Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).  Occasional extended hour and / or off-hour work may be required.
• Some travel may be required to other manufacturing sites and Lilly’s corporate office

This job description is intended to provide a general overview of the job requirements at the time it was prepared.  The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes.  As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 (https://careers.lilly.com/us/en/workplace-accommodation) 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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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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