Senior Manager, Parenteral Operations (Nights)

About the role

Lilly is investing over $2 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina. The Senior Manager, Parenteral Operations (Nights) will support staffing, training, and leadership of the parenteral group during asset delivery, process development, operations readiness, start-up, and validation of the parenteral (PAR) areas.

Responsibilities

• Supports staffing, training, and leadership of the parenteral group during asset delivery, process development, operations readiness, start-up, and validation of the parenteral (PAR) areas.
• Supports meeting annual production goals once the facility is turned over to operations.
• Supports the operations investigation and procedures to Regulatory Agencies and acts as a Subject Matter Expert (SME).
• Ensures consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
• Maintains and communicates metrics to measure performance against business objectives and makes necessary changes to continuously improve.
• Develops and implements strategies focused on Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE).
• Supports 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 5 – 20 individuals. Provides leadership and develops objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people.
• Acts as a secondary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety.

Requirements

• Bachelor's degree in a STEM or pharmaceutical related field of study.
• At least 2 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 cGMP standards and FDA (or other industry) guidelines for production.
• Experience with aseptic filling, single use assemblies, isolator technology.
• Experience with automated, semi-automated, and/or manual inspection.
• Experience with highly automated equipment (inspection, packaging, filling, assembly, etc.).
• Experience with creation of standard operating procedures, work instructions, and training documentation.
• Experience with equipment & facility design documentation reviews.
• Experience with facility, equipment, or system start up.
• Experience with qualification and process validation.
• Experience with Manufacturing Execution Systems and electronic batch release.
• Experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs.
• Experience with continuous improvement methodologies and mindset – lean, six sigma, etc.
• Experience with documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat).

Benefits

• Eligible for medical, dental, vision and prescription drug benefits.
• Eligible for a company bonus (depending, in part, on company and individual performance).
• Eligible for a company-sponsored 401(k); pension.
• Eligible for flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Eligible for life insurance and death benefits.
• Eligible for time off and leave of absence benefits.
• Eligible for well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $99,000 - $145,200.

Schedule

Frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and to build global network.