Night Shift Supervisor, Aseptic Filling

Eli Lilly and Company; Concord (NC); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking an Operations Supervisor to lead a new, state-of-the-art facility in Concord, North Carolina. This exciting role involves overseeing the start-up of parenteral operations and cultivating a culture of safety and excellence. You will be instrumental in training staff, ensuring compliance with cGMP standards, and driving continuous improvement initiatives. With opportunities for domestic and international travel, this position offers a unique chance to make a significant impact in a growing organization committed to innovative healthcare solutions. If you are passionate about leading teams and enhancing operational efficiency, this role is perfect for you.

Benefits

Health Insurance

Retirement Plan

Paid Time Off

Training and Development Programs

Flexible Work Hours

Employee Assistance Program

Qualifications

• High school diploma required; STEM degree preferred.
• 4+ years in manufacturing/operations, with 2+ years in supervisory roles.

Responsibilities

• Lead and supervise operations in the Parenteral area.
• Ensure safety, quality, and compliance in manufacturing processes.

Skills

Supervisory Experience

Basic Computer Skills

Interpersonal Communication

Organizational Skills

Technical Aptitude

Knowledge of cGMP Standards

Root Cause Analysis

Education

High School Diploma or Equivalent

STEM Degree or Certification

Tools

Manufacturing Execution Systems

SAP or Other Electronic Business Systems

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Position Overview

Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 Billion to build a completely new, inspiring, environmentally conscious, and highly automated campus in Concord, North Carolina. This brand-new campus will utilize the latest technology to increase the company’s capacity in parenteral (injectable) medications, device assembly, and packaging operations. This is an exciting and once-in-a-lifetime opportunity to build and operate a new site.

If you ever wanted to have a direct impact building a team’s culture and in how the team operates, now is the perfect opportunity!

During the project phase, the Operations Supervisor will have responsibility of supporting start-up activities to bring the Parenteral (PAR) area into service. The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. Activities will include coordinating start-up support amongst self and team to train on the use of the equipment and develop technical proficiency, develop a diverse and inclusive culture, and lead operational readiness activities. This position will require travel domestically (2-4 week trips and/or 3-12 month short term assignments) with the opportunity for travel internationally to collaborate and learn from sites who produce our medicines currently.

Once the facility is turned over to operations, the Supervisor role is responsible for leadership of the team that operates the multiple PAR. They will develop an inclusive culture and technical expertise of manufacturing team and employees. This individual will ensure that the lines are adequately staffed with trained & qualified employees. Strict adherence to safety and quality rules and procedures is expected. Direct line supervision for this role includes line leaders and operators.

As a site leader and expert at our growing site, you’ll have significant opportunities for growth into future leadership and technical roles.

Key Objectives / Deliverables:

Integrity

• Leading by examples 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.
• Responsible for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting HSE goals.
• Act as both administrator and technical leaders for operations. Set a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.

Excellence

• Collaborate with area supervisors to ensure a high standard of communication, best practice sharing, and consistency across the groups and different shifts.
• Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence.
• Striving and encouraging a mindset of continuous improvement. Gathering ideas for improvement, articulating their business value, and working with support team to implement the ideas with highest objective value.
• Ensures there are enough adequately trained and compliant personnel staffed to meet production goals. Reviews and updates training plans as needed to maintain compliance and excellence.
• Develop area documentation (procedures, work instructions, job aides, etc.) with team to support start-up, training, and operation.
• Originate & Investigate deviations, operational quality issues, and support determination of root cause. Support implementation of corrective actions to ensure consistent quality.

Respect for People

• Support the site in building a diverse, empowered, and capable team.
• Responsible for managing several direct reports working across multiple manufacturing lines on responsible shift.
• Responsible for the coaching, development, and performance evaluation of operators.
• Communicate cross functionally with support team if there are quality, equipment, operational concerns.

Requirements (Education, Training, and Experience)

Education, Experience and Skills

• High School Diploma or equivalent
• Prior supervisory experience
• Basic computer skills (desktop software, MS Office) are required.
• Previous experience in operations or directly supporting a manufacturing operation (Pharma, Food, Clean-room, or other applicable).
• Excellent interpersonal, written, and oral communication skills
• Strong organizational skills and ability to handle and prioritize multiple requests.
• Strong technical aptitude and ability to train and mentor others.
• A valid drivers license

Time Commitments and Work Authorization

• Ability to work overtime as required
• Ability to wear safety equipment (glasses, shoes, gloves, etc)
• Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
• The position may require a short term assignment of 3-12 months domestically or internationally to train and be certified on existing processes and establish global contacts. There may also be a requirement for short (less than 1 month) travel to support equipment testing at the manufacturer’s factory.
• Willingness to work a 12-hour night shift (6pm to 6am on 2-2-3 schedule)
• Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Preferred Attributes:

Experience with, completion of, or understanding of:

• 4+ years in manufacturing/operations with 2+ years in supervisory role
• cGMP standards and FDA (or other industry) guidelines for production
• STEM degree or certification
• Aseptic filling, single use assemblies, isolator technology.
• Automated, semi-automated, and/or manual inspection.
• Highly automated equipment (inspection, packaging, filling, assembly, etc.)
• Manufacturing Execution Systems and SAP or other electronic business systems
• Continuous improvement methodologies and mindset – lean, six sigma, etc.
• Root cause analysis and implementing corrective actions
• Ability to organize and motivate teams
• Facility, Equipment, Systems, Start-up