Associate Director - Biotech Operations

Overview

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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 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 put people first and seek individuals determined to make life better for people around the world.

Position Title : Associate Director Biotech Operations

Reporting To : Senior Director Biotech Operations

Lilly is constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland.

This facility will be Lilly's most technically advanced manufacturing site with next-generation technologies and advanced data platforms to improve safety, quality, productivity, and process performance.

This is a unique opportunity to be part of the leadership team for the startup of a greenfield manufacturing site, building the organization, facility and culture to enable a successful startup GMP manufacturing operation.

Main Purpose And Objectives Of Position

The Associate Director Biotech Operations provides leadership and direction to the cross-functional process team and the manufacturing operations team to meet short- to mid-term goals, including day-to-day technical leadership activities.

The leader ensures that the team is resourced and integrated with the site's longer-term objectives.

Key Responsibilities

The following are the main routine objectives for the Associate Director Biotech Operations role.

Daily Operations / Business Management

Promotion of a strong Safety and Quality culture.

Participation in the creation, approval and execution of the production plan for the assigned area.

Maintain a safe working environment and conduct production activities in a manner that protects safety, environment and quality.

Ensure consistency of operations across shifts through active engagement on the production floor.

Ensure all necessary systems, procedures, equipment and facilities are installed, qualified, validated, maintained to appropriate standards.

Support New Product Introductions to the site as required.

Support and provide leadership to the area through site inspections.

Own the implementation of the change and improvement agenda for the assigned area.

Setting objectives for the cross-functional Process Team, and owning and reviewing their scorecard with management.

Manage events as required, ensuring appropriate communication within the team and with external teams.

Provide input and approve investigations.

People Management

Build 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.

Manage people training, qualification and performance.

Set job expectations and goals for individuals linked to team / site goals.

Develop people.

Communicate appropriately with team members regarding site objectives and team business.

Ensure the team is adequately resourced to meet the business objectives.

Site Management Role

Manage collaborations between the team and functional support groups such as maintenance, engineering, analytical, financial, purchasing and technical support.

Be an engaged member of the cross-functional management team and active in Site Management.

Startup Phase – Leadership Expectations

Collaborative, inclusive, energetic leadership to support the broader Limerick team.

Build the organization with capability, capacity and culture to operate the facility to high standards.

Develop and implement systems and processes to run the site, leveraging Lilly knowledge while incorporating external experiences.

Ensure regulatory compliance and operational excellence by supporting lean principles and a digitally native approach.

Support project decisions and strategies to meet deliverables and longer-term site goals.

Pre Requisites

Previous GMP manufacturing experience and / or experience with an operations team, ideally in biopharmaceuticals.

Prior supervision / leadership of a cross-functional team or project.

Educational / Experience Requirements

Bachelor of Science, Engineering or equivalent experience.

Preferred >

8 years of industrial experience in a cGMP environment.

Additional Skills / Preferences

Strong interpersonal communication skills.

Ability to work independently and proactively.

Ability to resolve conflict and promote good decision making.

Solid understanding of regulatory requirements (FDA, HPRA, HSA, EPA).

Key Attributes

Business Knowledge : High performance and proactive problem solving.

Learning agility and curiosity : Ability to deal with ambiguity and prioritize problems.

Positive Influence : Trustworthy and action-oriented; seeks feedback for improvement.

Relationship Builder : Able to establish relationships across levels.

Ability to lead people : Experience in leading and motivating teams and influencing across functions.

Communication : Strong written and oral communication.

Decision Making : Decisive with ability to gather information and ask the right questions.

Lilly is committed to equal opportunity employment and to providing reasonable accommodations to applicants with disabilities.

If you require accommodation to submit a resume, please complete the accommodation request form.

Lilly does not discriminate on age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.

Job Function

Management and Manufacturing

Industries

Pharmaceutical Manufacturing

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