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Manager Operations – Parenteral Manufacturing

Durham, North Carolina

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Req ID R-13376 Title Manager Operations – Parenteral Manufacturing City Durham State / Province North Carolina Country United States

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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the global 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.

Position Brand Description:

Lilly unites caring with discovery to create medicines that make life better for people around the world.  Lilly is a fortune 500 company that has been in operation for over 140 years.  We make medicine with safety first and quality always while living our company values of Integrity, Excellence, and Respect for People.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located at the Research Triangle Park (RTP) in North Carolina.  This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site from the ground up.

The Operations Manager for parenteral operations is responsible for the staffing, training, and leadership of the operations group supporting asset delivery, process development, operational readiness, start up, and validation of the parenteral operations areas.  After start up, the operations manager will be responsible for overseeing the day-to-day activities of their operational area as well as planning for the 3 - 6 month horizon.  They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational execution, sterility assurance, and continuous improvement. The Manager is also responsible for leading their respective process team per Lilly’s Manufacturing Standards for Operational Excellence.

Key Objectives/Deliverables:

  • Support Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.

  • Managers are responsible for a work force of approximately 40 – 70 individuals on various shifts, with multiple shift supervisors reporting directly to them.

  • Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations.

  • Provide leadership and develop objectives to deliver Business Plan Goals as it relates to production volumes, financial, safety, quality, stewardship, and people.

  • Maintain metrics to measure performance against business objectives and make necessary changes to improve performance.

  • Participates in the development and implementation of strategies associated with the area sponsoring or supporting the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).

  • The Manager functions as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety issues.

  • This role has direct interaction with Regulatory Agencies during site inspections.

  • Managers are responsible for leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support.

  • Understand and influence the manufacturing control strategy for their area.

  • Represent their Operations Process Team on the Plant Flow Team.

Minimum Requirements:

  • At least 7 years working in the pharmaceutical industry.

  • Previous management or leadership experience including leading or working effectively with a cross functional group.

  • Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.

  • Excellent interpersonal, written and oral communication skills

  • Strong technical aptitude and ability to train and mentor others

Additional Preferences:

  • Previous experience in operations

  • Previous experience in aseptic operations

  • Previous experience with highly automated equipment

  • Previous experience with combination products, Device Assembly, Pharmaceutical Packaging.

  • Previous facility or area start up experience.

  • Previous equipment qualification and process validation experience.

  • Previous experience with Manufacturing Execution Systems and electronic batch release.

  • Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.

  • Previous experience in statistical process control and Six Sigma concepts

  • Previous experience with deviation and change management systems including Trackwise.

Education Requirements:

  • Bachelors degree in a science, engineering, or pharmaceutical related field of study.

Other Information:

  • The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.

  • Position may require a short duration assignment of 1-2 months in Indianapolis to establish specific device knowledge and establish global contacts.

  • Ability to work 8 hour days – Monday through Friday

  • Ability to work overtime as required

  • Ability to travel up to 20% during Asset Delivery and < 10% after startup

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

To submit resume, visit https://www.lilly.com/careers and apply to Req ID R-13376.

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.

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