Associate Director - Parenteral Operations Expansion

Lilly • Kenosha, WI

85d • $118,500 - $173,800

About The Position

The Associate Director, Parenteral Operations Expansion 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 Kenosha parenteral expansion. 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.

Requirements

• 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.

Nice To Haves

• 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).

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.
• 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 initiatives such as 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.
• Function 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.

Benefits

• Eligibility to participate in a company-sponsored 401(k); pension.
• Vacation benefits.
• Eligibility for medical, dental, vision and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree