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 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, disabi
Benefits
Health insuranceFlexible schedule
Additional Information
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.
Eli Lilly · Indianapolis IN