Associate Director, Parenteral Operations

About the role

The AD role is responsible for ensuring the group meets annual production goals as well as planning through 1-3 year horizons. They are expected to lead by example and provide coaching to others in the areas of safety, quality, operational excellence, compliance, and continuous improvement. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates.

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.
• 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.
• 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.

Qualifications

• Authorized to work in the United States on a full-time basis.

Skills

• Experience with, completion of, or understanding of: 6+ years in manufacturing/operations with 4+ years in supervisory role.
• Excellence in; interpersonal, electronic, written, and oral communication.
• Strong technical aptitude and ability to train and mentor others.
• 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).

Benefits

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).