Lilly
healthcare
AssociateDirector-TSMSDryExternalManufacturing
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“Associate Director - TSMS Dry External Manufacturing at Lilly. Skills: process management, cross-functional coordination, vendor/stakeholder management. Manage activities of TS/MS and ENG personnel supporting external manufacture.. Balance coaching technical and engineering staff.”
What You'll Achieve.
deliver on technical /engineering objectives; deliver on specific product business plan; deliver on quality objectives; improve process control; improve yield; improve productivity; ensure adequate oversight and technical excellence for investigations and complaints including CAPA and monitoring improvement; improve process control; improve capacity; improve yield; improve quality; ensure JPT objectives and priorities are delivered
Industry & Context.
analytical and quantitative problem-solving skills
~20-30% travel may be required, Some off-shift work (night/weekend) may be required to support 24/7 operations across global networks
What They're Looking For.
Must Have
Bachelor's Degree in scientific disciplines of Chemistry, Biology, Biotechnology, Pharmacy, Engineering or another related field., 8+ years’ experience in Dry Products/Oral Solid Dose pharmaceutical manufacturing environment in any of the following associated disciplines: TSMS, Production, Engineering at a manufacturing site., Previous leadership/people management experience.
Nice to Have
Ability to represent Eli Lilly´s mission, policies and practices in a positive, professional and ethical manner to influence CMs., Responsible for maintaining a safe work environment, Ability to influence and inclusively lead diverse groups, Influences complex regulatory/quality, business, or technical issues within the site and function, Experience in statistics, Technical leadership, administrative and organizational skills, Builds relationships with internal and external customers and partners, Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional, Ability to manage/lead coordinate complex projects, 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, Enthusiasm for changes, team spirit and flexibility, Demonstrated ability to learn & apply technical/scientific knowledge, Capability to work in a virtual and complex environment
What You'll Do.
Manage activities of TS/MS and ENG personnel supporting external manufacture.
Balance coaching technical and engineering staff.
Prioritize and staff for routine production support.
Implement technical projects.
Oversee technical transfers.
Oversee commercialization.
Oversee process optimizations.
Oversee engineering activities.
Ensure technical review and approval for documents.
Manage performance and development of staff.
Influence and implement the technical agenda.
Ensure technical and Engineering oversight of manufacturing and packaging.
Interact with regulators
or other outside stakeholders.
Define strategic direction and provide oversight for technical agenda.
Ensure adequate oversight and technical excellence for investigations and complaints.
Ensure adequate oversight for technical projects.
Ensure adequate technical representation and engagement in governance meetings.
Network globally to share best practices.
Build relationships external to Lilly.
Engage and influence Pharmaceutical Product Development groups.
Escalate risks to Sr. Leaders.
Lead implementation and execution of activities aligned with emerging need.
Contribute to CM selection process.
Contribute to Business Plan and Strategic Plan processes.
Serve as cross-functional member on DryEM Lead Team.
Ensure JPT objectives and priorities are delivered.
Support financial planning and reporting for Dry EM.
How You'll Work.
Team & Collaboration
working cross-functionally within sites, network, commercialization teams, and multiple global contract manufacturers; Partner within TS/MS, ENG and across functional disciplines; Interact with regulators, customers, or other outside stakeholders; Ensure adequate technical representation and engagement within site and network governance meetings; Network globally to share best practices, rationale, and control strategies; Build relationships external to Lilly; Engage and influence Pharmaceutical Product Development groups; Serve as cross-functional member on DryEM Lead Team; TS/MS, ENG functions at other Lilly locations; All relevant functions within external manufacturers; Internal Manufacturing Nodes; Dry team; API-EM group; External Manufacturing Organizations; Lilly GQAAC; Lilly Global Supply Chain functions; Lilly Teach @ Lilly functions; Lilly Geneva and IHL Kinsale; Lilly External Manufacturing Support Teams; Ability to influence and inclusively lead diverse groups; Builds relationships with internal and external customers and partners; Ability to communicate and influence effectively across functional groups and stakeholders
Communication Scope
Ability to communicate and influence effectively across functional groups and stakeholders
Process & Methodology
implementation of technical projects, technical projects, Ability to manage/lead coordinate complex projects
Full Job Description
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: 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 – Technical Services/Manufacturing Science (TS/MS) Dry Products External Manufacturing (Dry EM) is responsible for managing the activities of TS/MS and ENG personnel supporting the oversight of external manufacture of dry products. The Assoc. Director TSMS must balance coaching a technical and engineering staff, prioritization and staffing for routine production support activities, implementation of technical projects, technical transfers, commercialization, process optimizations and engineering activities oversight. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation and engineering practices. The position requires working cross-functionally within sites, network, commercialization teams, and multiple global contract manufacturers to deliver on technical /engineering objectives, specific product business plan, and quality objectives. **Key Objectives/Deliverables:** * Ensure technical review an
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