Associate Director - TSMS Dry External Manufacturing

Lilly • Carolina, IN

22h • Hybrid

About The Position

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.

Requirements

• 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.
• 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.
• 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.
• Enthusiasm for changes, team spirit and flexibility.
• Demonstrated ability to learn & apply technical/scientific knowledge.
• Capability to work in a virtual and complex environment.

Responsibilities

• Managing the activities of TS/MS and ENG personnel supporting the oversight of external manufacture of dry products.
• Balancing 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.
• Ensuring technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
• Performance management and development of staff.
• Partnering within TS/MS, ENG and across functional disciplines to influence and implement the technical agenda, site business plan objectives, functional objectives, and GMP Quality Plan objectives.
• Ensuring appropriate technical and Engineering oversight and stewardship of oral solid dose form manufacturing and packaging including drug product intermediates (e.g. spray dried dispersions/amorphous solid dispersions).
• Interacting with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits.
• Defining strategic direction and providing oversight for setting the technical agenda to improve process control, yield, and/or productivity for all products within the site portfolio.
• Ensuring adequate oversight and technical excellence for investigations and complaints including CAPA and monitoring improvement.
• Ensuring adequate oversight for technical projects/technical agenda to improve process control, capacity, yield, quality.
• Ensuring adequate technical representation and engagement within site and network governance meetings to influence technical agendas.
• Networking globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites.
• Building relationships external to Lilly to create benchmarks opportunities and identify best practices.
• Potential to engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization.
• Escalating to Sr. Leaders in a timely fashion risks to supply, manufacturing issues major deviations, critical complaints or safety and cybersecurity issues.
• Leading implementation and execution of activities aligned with emerging need related to process improvement, control strategy or new regulation and ensuring any emerging need is incorporated into the CMs technical agenda.
• Contributing to CM selection process by assessing capabilities of external companies and providing functional recommendations to sourcing options.
• Contributing to Business Plan and Strategic Plan processes.
• Serving as cross-functional member on DryEM Lead Team.
• Ensuring JPT objectives and priorities are delivered and issues escalated.
• Supporting financial planning and reporting for Dry EM.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager