Eli Lilly and
Associate Director - Parenteral Operations Expansion
Eli Lilly and, Pleasant Prairie, Wisconsin, United States, 53158
Overview
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, with employees worldwide who work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. We put people first and are looking for individuals determined to make life better for people around the world.
Responsibilities
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.
Associate Director is responsible for a workforce of approximately 25 - 50 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 needed changes to improve performance.
Participate in the development and implementation of strategies associated with the area sponsoring or supporting initiatives such as Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE).
Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) groups.
Serve as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety issues.
Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for audit tours and discussions.
Lead 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 the Process Team on the Parenteral Flow Team.
Basic Qualifications
Bachelor's degree in a science, engineering, or pharmaceutical-related field of study.
5+ years experience working in the pharmaceutical manufacturing industry.
2+ years management or leadership experience including leading or working effectively with a cross-functional group.
Solid understanding of basic regulatory requirements from agencies such as the FDA, EMEA, DEKRA, and OSHA.
Preferred attributes (not required)
Excellent interpersonal, written, and oral communication skills.
Strong technical aptitude with ability to train and mentor others.
Previous experience in operations and with automated, semi-automated inspection, and manual inspection.
Previous experience with highly automated equipment and with creation of Standard Operating Procedures and Work Instructions.
Previous experience with equipment design documentation reviews, facility or area start-up experience, and equipment qualification and process validation.
Previous experience with Manufacturing Execution Systems and electronic batch release.
Previous experience with ASRS warehouses or AGVs.
Previous experience in statistical process control and Six Sigma concepts.
Previous experience with documentation, deviation and change management systems (e.g., Trackwise, Veeva QualityDocs).
Compensation and benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. Estimated wage ranges include: $118,500 - $173,800 and $123,000 - $180,400. Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefits program including a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life and death benefits; and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.
#WeAreLilly
EEO and accommodations Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities in hiring. If you require accommodation to submit a resume, please complete the accommodation request form (no link included here) for further assistance. This is for accommodation requests 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.
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Responsibilities
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.
Associate Director is responsible for a workforce of approximately 25 - 50 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 needed changes to improve performance.
Participate in the development and implementation of strategies associated with the area sponsoring or supporting initiatives such as Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and Operational Standards for Supply Chain Excellence (OSSCE).
Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) groups.
Serve as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety issues.
Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for audit tours and discussions.
Lead 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 the Process Team on the Parenteral Flow Team.
Basic Qualifications
Bachelor's degree in a science, engineering, or pharmaceutical-related field of study.
5+ years experience working in the pharmaceutical manufacturing industry.
2+ years management or leadership experience including leading or working effectively with a cross-functional group.
Solid understanding of basic regulatory requirements from agencies such as the FDA, EMEA, DEKRA, and OSHA.
Preferred attributes (not required)
Excellent interpersonal, written, and oral communication skills.
Strong technical aptitude with ability to train and mentor others.
Previous experience in operations and with automated, semi-automated inspection, and manual inspection.
Previous experience with highly automated equipment and with creation of Standard Operating Procedures and Work Instructions.
Previous experience with equipment design documentation reviews, facility or area start-up experience, and equipment qualification and process validation.
Previous experience with Manufacturing Execution Systems and electronic batch release.
Previous experience with ASRS warehouses or AGVs.
Previous experience in statistical process control and Six Sigma concepts.
Previous experience with documentation, deviation and change management systems (e.g., Trackwise, Veeva QualityDocs).
Compensation and benefits Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. Estimated wage ranges include: $118,500 - $173,800 and $123,000 - $180,400. Full-time employees are eligible for a company bonus (dependent on company and individual performance). Lilly offers a comprehensive benefits program including a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life and death benefits; and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion.
#WeAreLilly
EEO and accommodations Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities in hiring. If you require accommodation to submit a resume, please complete the accommodation request form (no link included here) for further assistance. This is for accommodation requests 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.
#J-18808-Ljbffr