Lilly
Associate Director - Filling and Formulation
Lilly, Pleasant Prairie, Wisconsin, United States, 53158
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.
The Associate Director, Operations - Filling 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 starting up, the Associate Director will be responsible for leading all aspects of 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.
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 50 - 100 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.
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).
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) functional groups.
The Associate Director functions 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.
Associate Directors 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 the Filling 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 requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
Preferred attributes but not required:
Excellent interpersonal, written, and oral communication skills.
Strong technical aptitude and ability to train and mentor others.
Previous experience in operations.
Previous experience in automated, semi-automated inspection, and manual inspection.
Previous experience with highly automated equipment.
Previous experience with creation of Standard Operating Procedures, Work Instructions etc.
Previous experience with equipment design documentation reviews.
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 documentation, deviation and change management systems (e.g., Trackwise, Veeva QualityDocs).
This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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 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 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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The Associate Director, Operations - Filling 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 starting up, the Associate Director will be responsible for leading all aspects of 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.
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 50 - 100 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.
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).
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) functional groups.
The Associate Director functions 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.
Associate Directors 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 the Filling 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 requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
Preferred attributes but not required:
Excellent interpersonal, written, and oral communication skills.
Strong technical aptitude and ability to train and mentor others.
Previous experience in operations.
Previous experience in automated, semi-automated inspection, and manual inspection.
Previous experience with highly automated equipment.
Previous experience with creation of Standard Operating Procedures, Work Instructions etc.
Previous experience with equipment design documentation reviews.
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 documentation, deviation and change management systems (e.g., Trackwise, Veeva QualityDocs).
This job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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 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 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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