Senior Manager, Parenteral Operations (Nights)

Eli Lilly and Company • Concord, NC

19d • $99,000 - $145,200 • Onsite

About The Position

Lilly is investing over $2 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which 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. This is a unique opportunity to have a direct impact on building a team’s culture and on how the team operates. During the project phase, 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. This position is intended to serve as the primary leadership point of contact for the parenteral area during the night. This position may also require travel domestically with the opportunity for travel internationally to collaborate and learn from existing Lilly sites. Once the facility is turned over to operations, the Senior Manager, Parenteral Operations (Nights) will support meeting annual production goals. The Senior Manager, Parenteral Operations (Nights) is expected to lead by example and provide 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. As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles.

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.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
• Ability to wear safety equipment (glasses, shoes, gloves, etc.)
• Ability to work 40 hours per week with overtime and flexibility to work off shift as required to meet key objectives.
• Excellence in; interpersonal, electronic, written, and oral communication
• Strong technical aptitude and ability to train and mentor others

Nice To Haves

• 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)

Responsibilities

• 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 Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), and 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.
• 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 secondary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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: Senior