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. This campus will house warehousing & logistics, operations including parenteral, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need. The Senior Manager, Parenteral Operations (Nights) is responsible for supporting staffing, training, and leadership of the parenteral group during asset delivery, process development, operations readiness, start-up, and validation of the parenteral (PAR) areas which include formulation, aseptic filling, and visual inspection 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 which include formulation, aseptic filling, and visual inspection areas.
• Serves as the primary leadership point of contact for the parenteral area during the night.
• Maintains and communicates metrics to measure performance against business objectives and make necessary changes to continuously improve.
• Participates 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).
• Supports meeting annual production goals once the facility is turned over to operations.
• Leads by example and provides coaching to others in the areas of safety, quality, operational excellence, compliance, and continuous improvement.
• Direct line supervision for this role includes supervisor(s) and dotted line oversight of other parenteral supervisors.

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.
• Strong 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.
• Excellence in interpersonal, electronic, written, and oral communication.
• Strong technical aptitude and ability to train and mentor others.

Skills

• Experience with, completion of, or understanding of: 3+ years in manufacturing/operations with 2+ 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).

Benefits

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).

Pay

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

Schedule

This position will involve 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.