Associate Director, Parenteral Operations

About the role

The Associate Director, Parenteral Operations role is responsible for ensuring the group meets annual production goals and plans through 1-3 year horizons. They lead by example and provide coaching to others in safety, quality, operational excellence, compliance, and continuous improvement. The role leads their respective cross-functional process teams.

Responsibilities

• Leading by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation.
• 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.
• Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions.
• Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
• Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve.
• Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
• Understand and influence the manufacturing control strategy for their area.
• Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.
• Responsible for a work force of approximately 40 – 70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them.
• Provide leadership and develop objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people.
• Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety.
• Represent their Operations Process Team on the Plant Flow (value stream) Team.

Requirements

• Bachelor's degree in a STEM or pharmaceutical related field of study.
• 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/or OSHA.
• Excellence in; interpersonal, electronic, written, and oral communication.
• Strong technical aptitude and ability to train and mentor others.

Qualifications

• 6+ years in manufacturing/operations with 4+ years in supervisory role.
• cGMP standards and FDA (or other industry) guidelines for production.
• Aseptic filling, single use assemblies, isolator technology.
• Automated, semi-automated, and/or manual inspection.
• Highly automated equipment (inspection, packaging, filling, assembly, etc.).
• Creation of standard operating procedures, work instructions, and training documentation.
• Equipment & Facility design documentation reviews.
• Facility, equipment, or system start up.
• Qualification and process validation experience.
• Manufacturing Execution Systems and electronic batch release.
• Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
• Continuous improvement methodologies and mindset – lean, six sigma, etc.
• Documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat).

Skills

• Leadership
• Quality Management
• Operational Excellence
• Compliance
• Continuous Improvement
• Project Management
• Teamwork
• Communication
• Technical Aptitude

Benefits

Details about benefits will be provided in the job offer letter.

Pay

$123,000 - $180,400

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).