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:
The IPM TS/MS Central Team is a new team provides centralized TS/MS support for both the Insulin and Syringe Plants. This group will own Components, Materials, Annual Product Review, and Visual Inspection Qualifications.
**Responsibilities: **
The Associate Director, TS/MS Central Team role will report directly to the IPM TS/MS Associate Vice President and will be responsible for leading and mentoring the technical staff.
- Responsible for maintaining a safe work environment, leading safety initiatives, and working safely and accountable for supporting all HSE Corporate and Site Goals.
- Drive safety and quality culture within the organization
- Understand the scientific principles required for manufacturing products in area of influence including the interaction of the chemistry, equipment, materials, aseptic processes, and container closure systems.
- Provide technical guidance to the TS/MS group.
- Understand and influence the manufacturing control strategy for the various operational areas.
- Drive control, capability, productivity, and continuous improvement for the process.
- Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, APRs, etc. Work cross-functionally with the area process teams for metrics reviews, operational support, and issue / deviation management.
- Provide oversight for interactions with external component and material suppliers/vendors and engaging directly as needed; partner with Procurement and Materials Management QA to support GMP supplier qualification activities.
- Partner within TS/MS and across functional disciplines to influence and implement the technical agenda, site business plan objectives and GMP Quality Plan objectives
- Network and collaborate with global and other parenteral sites to understand best practices, share knowledge, and participate in tactical and strategic business planning.
- Support site inspection readiness and execution. This role may have direct interaction with Regulatory Agencies during site inspections.
- Performance management and development of staff
**Basic Requirements: **
- Bachelor’s Degree in scientific disciplines of Material Science, Chemistry, Biology, Pharmacy, Engineering.
- 5+ years of pharmaceutical manufacturing experience in TS/MS or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, or Engineering.
- 3+ years of experience leading teams
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Skills/Preferences:
- Strong technical aptitude and ability to train and mentor others
- Proven Teamwork and interpersonal skills
- Problem solving and independent decision-making skills
- Oral and written communication skills that demonstrate an ability to effectively (e.g., clearly, succinctly) communicate with all levels of the organization.
- Ability to influence diverse groups
- Previous experience with deviation and change management systems
- Experience interacting with external vendors, including technical discussions, issue resolution, and change notifications.
- Understanding of GMP supplier qualification processes (e.g., risk-based assessment, audits, quality agreements, and ongoing supplier performance monitoring).
Additional Information:
- Role is Monday through Friday based.
- Must be flexible in providing support to 24/7 operations
- Occasional extended hour and / or off-hour work may be required.
- 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
$123,000 - $180,400
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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