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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$118,500 - $173,800

Position Brand Description:

The Clinical Trial (CT) Manufacturing organization is responsible for the on-time delivery of drug product in support of clinical trials (Phase 1 through 4) as well as the associated technical information deliverables in support of regulatory submission. CT Manufacturing is accomplished either externally at approved, qualified External Contract Manufacturing sites, both in the US and OUS, or internally at Lilly manufacturing facilities. The CT Manufacturing organization has responsibility for both the technical and operational components of drug product supply.

The Associate Director, CT Manufacturing and Operations has accountability for the leadership, supervision, and development of the team members. The team includes NDP Material Coordinators, Plant Planners and Principal Scientist (CT Mfg Tech Reps). The team provides manufacturing and operational support such as manufacturing site planning, manufacturing oversight and issue resolution, purchase requisition management and logistic coordination for physical material movement, for the assets in the portfolio in all phases of drug development.

In addition, this role is expected to be an authority and champion for Operational Excellence and selected continuous improvement projects.

Responsibilities:

Manufacturing and Operations Responsibilities:

• Partner with supply planning to understand portfolio supply needs and timing formoleculesbeingsupported. Ensuring manufacturing site capacity and confirmed planning to meet supply needs. Advancing if delays may cause potentialpatient impact.

• Partner with internal and / or external manufacturing sites. Facilitate appropriate governance, align on priorities, and work together to supply clinical drug product and support the portfolio.

• Support oversight of manufacturing process andissueresolutionformoleculesbeingsupported.

• Review, approve and give guidance on manufacturing-based deviations, change controls and technical issues. Navigate in Quality Systems such as Trackwise and Veeva.

• Coordinate logistics for shipment of raw materials, components and drugproductinsupport for drugproductmanufacturing and supply.

• Responsible for on time batch release of the molecules supported by the team.

• Partner with drug substance manufacturing teams to understand timing and impact to NDP manufacturing schedule

• Identifies, proposes, and leads innovativesolutions for organizational, technicalandoperational challenges. Includes appropriate use of Operational Excellence methodologies and ensures the team is appropriately represented and involved in cross-functional process improvement projects.

• Ensures effective sharedlearning across the function as well as application of sharedlearning and standard processes.

• Champion of SafetyandQuality.Committed to ensuring a safe work environment for the team and the highest quality drug product for our patients.

• Understand and apply cGMP’s in a drugproductmanufacturing environment, across the technical, operational and business processes.

• Organizational Leadership:

• Partner with leadership and other functions, to establish a strategy and associated yearly objectives along with associated metrics to measure success; leads team toward achieving strategy and goals.

• Develops and facilitates resourcing strategy and decisions including recruiting and hiring activities; work closely with team and functional management to ensure group is fully and appropriately resourced according to staffing strategies and portfolio priorities.

• Management and supervision of team including Performance Management process anddevelopmentof re- porting staff members; provides input into merit/compensation, talent assessment, and succession planning discussions forreportingstaffmembers,mentoring and robust development.

• Responsible for developing the team budget (e.g. travel, training, supplies).

• Holds individuals accountable for their performance management objectives; ensures directreports adhere to current policies and procedures and training requirements; promotes application and consistency in using approved processes that will aid in meeting departmental and component objectives.

• Ensures development plans are in placeforreportingstaffmembers; contribute to staff development through administrative direction, coaching, mentoring,sharedlearning, and feedback; ensures staff skill development aligns with transformation toward future state functional and business objectives.

• Seeks opportunities to reward and recognize individuals; holds staff accountable to share any new learning.

• Ensures/oversees that on-boarding materials are up-to-date and distributed and discussed with staff new to the area; ensures that staff members have the information they need to do their jobs.

• Drives reviews and updates of curriculum maps and job descriptions as appropriate. Ensures all employees are compliantwith training requirements.

• Demonstrates model behaviors and establishes an environment where performance andbusinessresults are valued, and where individuals are learningandgrowing developmentally.

Operational Excellence Leadership Responsibilities:

• Team leader andchampionforoperationalexcellence for NDP Manufacturing Lead Team.

• Responsible for execution and success of assigned Daily Management System huddles and Joint Process Teams (JPTs), ie. Batch Release, Mfg Site JPT’s.

• Responsibleforthe identification, collection, and reporting of Key Performance Indicator (KPI) metrics data related to Delivery, SafetyandQuality of CT Manufacturing.

Basic Qualifications:

• Minimum of a B.S. in Pharmacy, Pharmaceutical Sciences, Chemical/Biochemical Engineering or related field.

• Demonstratedability to work and influence across multiple functions and regions, internal/external customers, and management.

• Practical experience leading a team to deliver on an objective, strong focus on customer andbusinessresults.

• Experience with drugproductmanufacturing (solid dose and/or parenteral)

• Excellent oral and written communication skills;ableto communicate clearly and succinctly with team members and leadership.

• Strong problem-solving skills: able to anticipate and recognize problems, diagnose root causes and take corrective action to prevent recurrence within the team.

• Excellent self-management and organizational skills;abletomanage workload, set personal and team priorities and adjust as needed.

• Strong interpersonal and teambuilding skills;ableto develop effective teamwork between team members with diverse interpersonal styles; able to deliver effective coaching and feedback.

• Able to drive behavior change through influence and/or through direct line supervision.

• Provenabilityto adjust quickly and effectively to frequent change and altered priorities.

• Provenabilityto lead and implement transformation.

Additional Skills and Preferences:

• Some domestic and/or international travel required (10%)

• Some work outside of core hours may be required to deliver the portfolio

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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