Associate Director Oligonucleotides Operations

3 weeks ago

Lebanon, United States Lilly Full time

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.
- 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 35,000 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._

**Position Brand Description**:
The Associate Director of Oligonucleotides Operations is directly responsible for managing the day-to-day manufacturing operations for oligonucleotides and provides oversight for the operational resources assigned to the Process Team, including Operations Leaders. The role is responsible for the leadership of frontline leaders in direct execution of manufacturing instructions (e.g., batch production record, SOP’s, etc.) in order to safely and compliantly manufacture high-quality medicine. The role serves as the key integrator of the cross-functional team to drive safety, quality, and continuous improvement in pursuit of Operational Excellence. The Associate Director of Oligonucleotides Operations provides leadership, acts as a key integrator, has accountability for the cross functional Process Team, and ensures that appropriate staffing is in place. The role will ensure equipment is maintained in a state of compliance and processes in a validated state for their respective area.

In the project delivery phase and startup phase of the project (startup expected 2025 to 2027), leadership roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Working with external contract manufacturing organizations (CMOs) to support external oligonucleotide synthesis, tech transfer and campaign execution will be an important aspect of this role.

**Key Objectives/Deliverables**:
Daily Operations/Business Management:

- Build and promote a strong Safety and Quality culture. Maintain a safe working environment and conduct production activities in a manner that protects safety, environment and quality.
- Participate in the creation, approval and execution of the production plan for the assigned area.
- Ensure consistency of operations across shifts through active engagement on the production floor.
- Support and provide leadership to the area through site inspections.
- Own the implementation of the change and improvement agenda for the assigned area, ensuring cross functional support and integration.
- Set objectives for the cross-functional Process Team and owning and reviewing their scorecard with management.
- Set objectives and development plans for Operations staff, including Operations Leaders and Operators.
- Manage events as required, ensuring appropriate communication within the team and with external teams. Provide input and approve investigations.
- Build and develop a team, creating clear common purpose and promoting good team spirit.
- Ensure that team members are appropriately trained, and that operating procedures and training material are available and current.
- Communicate appropriately with team members regarding site objectives and team business.
- Ensure the team is adequately resourced to meet the business objectives.

Specifically, during the startup phase of the Lebanon API site (2025 to 2027) leadership will be expected to be collaborative, inclusive, and support the broader team to:

- Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence
- Develop and implement the systems and processes needed to run the site, leveraging existing Lilly knowledge and practices where necessary, but also incorporating external experiences and learning
- Ensure regulatory compliance and operational excellence by supporting lean principles in their respective area
- Support the project team as they deliver the facility to the site team, by providing feedback and support.

**Basic Requirements**:

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