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.

Organization Overview:

For 140 years, Lilly has manufactured medicines that improve people’s lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

The TS/MS Associate Director is responsible leading/mentoring a technical staff and understanding parenteral aseptic processing as it relates to drug product manufacturing.  Provide guidance on time management and priorities for direct reports.  Manage routine production support activities while balancing implementation of technical projects and process optimizations.  Key position responsibility is to address and document GMP compliance issues and development / execution of validation plans.  The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation.  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:

Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.

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

Ensure adequate oversight and technical excellence for investigations and complaints.

Technical review and approval for site quality documents, plans, regulatory submissions, validation-related documents, and studies.

Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits

Define strategic direction and provide oversight for setting the technical agenda to improve process capability, process control, yield, and/or productivity for all products within the site portfolio.

Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.

Basic Requirements:

Bachelors or equivalent in scientific disciplines of Chemistry, Biology, Pharmacy, Engineering or a related field.

5+ years of relevant industrial experience in any of the following associated disciplines such as Manufacturing, Quality Control, Quality Assurance, Advanced Project Management, Development, Regulatory Sciences or Engineering.

Additional Preferences:

Experience in Sterile Drug Product Manufacturing.

Technical leadership, administrative and organizational skills.

Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional.

Demonstrated Project Management skills and ability to coordinate complex projects.

Strong analytical and quantitative problem-solving skills.

Ability to communicate and influence effectively across functional groups and stakeholders.

Strategic thinking and ability to balance short term needs with long term business evolution.

Demonstrated ability to learn & apply technical/scientific knowledge.

Additional Information:

Some off-shift work (night/weekend) may be required to support 24/7 operations.

Minimal travel 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 (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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