Associate Director - Joint Process Team Lead

Initial Therapeutics, Inc.; Lebanon (IN); On-site; USD 117,000 - 172,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Job summary

Lilly is building a cutting-edge facility in Lebanon, Indiana for Gene Therapy and other modalities, aiming to start up a greenfield site supporting clinical and commercial supply. The LP2-EM Joint Process Team Leader will drive cross-functional collaboration between Lilly and contract manufacturers, focusing on quality, regulatory compliance, and timely deliverables.

Key objectives include developing strategic plans, overseeing production and logistics, and maintaining strong external

Qualifications

• Bachelor’s degree in Chemical Engineering or related science.
• 5+ years in pharmaceutical manufacturing, technical support, QA, or quality engineering.
• Experience representing Lilly or large pharma with CM partners is a plus.

Responsibilities

• Lead cross-functional Joint Process Team (JPT) with CM to align quality and supply plans.
• Facilitate compliance to ensure continuous supply and regulatory adherence.
• Manage production, batch release, and shipment schedules to meet objectives.
• Communicate status to management and coordinate Steering Team actions.
• Deliver projects per GCMS and Quality Agreement requirements.

Skills

Leadership

Project management

cGMP compliance

TrackWise

SAP

Veeva Vault

Cross-functional collaboration

Education

Bachelor’s degree in Chemical Engineering

Tools

TrackWise

SAP

Veeva Vault

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Overview:

Lilly is currently constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products at Lilly. It will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state-of-the-art facility and build a manufacturing supply chain from ground-up. The LP2-EM Joint Process Team Leader is focused on relationship building internally and externally, leading the cross functional team and project prioritization and management for assigned relationships within Lebanon 2 External Manufacturing (LP2-ExM).

Key Objectives:

• Lead cross-functional Joint Process Team (JPT), between Lilly and contract manufacturer (CM), to develop and implement strategically aligned Quality and Supply Plans as well as the Technical Agenda for the CM.

• Successfully facilitate and champion quality, technical, and regulatory compliance to ensure continuous supply to the marketplace.

• Manage production, batch release and shipment schedules to ensure appropriate resources to meet objectives.

• Resolve supply chain issues and provide internal notification to management or joint Lilly/CM Steering Team as necessary.

• Accountable for the metrics that align with Global Contract Manufacturing Standards (GCMS) to monitor performance at the CMs, and to review these at API external manufacturing lead team meetings.

• Serve as liaison to communicate status and issues to various management levels in operations, quality, marketing, and manufacturing networks.

• Author Manufacturing Responsibilities Document (MRD) defining each party’s roles and responsibilities aligned with the contract and Quality Agreement.

• Ensure that the MRD and contracts are being adhered to by Lilly and the CM.

• Make regular visits to CM to increase awareness of operations and maintain a strong working relationship.

• Manage conflict and problem resolution.

• Facilitate Lilly/CM Steering Team meeting agendas with issues from the JPT meetings requiring Steering Team action. Present and document the decisions in Steering Team minutes.

• Meet regularly with customers (Lilly plant sites or Lilly affiliates) to ensure supply goals are met, review performance metrics and improve customer service.

• Evaluate and manage efficiencies with product supply chains. Work with Tech Service/QC/Engineering/QA Representatives and 6 Sigma on continuous improvement projects.

• Accountable for on time delivery of commitments to supply plan, quality plan, and technical agenda.

• Deliver all product / projects to comply with GQS, GCMS, and applicable internal SOP’s.

• Other tasks may include assisting Tech Service and QA personnel to ensure timely completion of APR, AR, MR as necessary.

Basic Requirements:

• Bachelor’s degree or equivalent in Chemical Engineering, Mechanical Engineering, Chemistry/Biochemistry or related science.

• 5+ years of experience in pharmaceutical manufacturing, technical support, quality assurance, and/or quality engineering.

Additional Preferences:

• Ability to represent Eli Lilly and Company in a positive, professional, and ethical manner to both internal (Affiliate) and third-party contract manufacturers.

• Strong leadership and interpersonal skills, ability to build effective relationships, influence and achieve results through people.

• Self-motivated with ability to react quickly to changing requirements and processes.

• Demonstrated experience aligning with, delivery of or assuring cGMP compliance of a production operation.

• Proficiency in Word/Excel/PowerPoint and knowledge of Lilly-based systems (i.e., Trackwise, SAP, Veeva Vault)

• Project management skills including the ability to lead teams to produce quality deliverables within established time frames.

• Proficiency in Microsoft Project.

• Experience with contracts and relationships with third party suppliers.

• Establish technical, quality, and business networks.

• Travel will be required ( 20%)

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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$117,000 - $171,600

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.

#WeAreLilly