Night Shift Supervisor, Aseptic Filling

BioSpace; Concord (NC); On-site; USD 48,000 - 72,000; Full time

Job summary

Lilly is building a new Concord, NC campus and seeks an Operations Supervisor to support startup of the Parenteral (PAR) area and later lead PAR manufacturing lines. You will train staff, ensure safety and quality, and drive readiness as the site scales.

The role emphasizes inclusive leadership, procedure development, staffing, and continuous improvement through cGMP, lean, and Six Sigma practices, supervising line leaders and operators.

Qualifications

• 4+ years in manufacturing/operations with 2+ years in supervisory role.
• cGMP standards and FDA 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).
• 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.

Responsibilities

• Lead start-up activities for the PAR area and train on equipment.
• Develop a diverse, inclusive culture and lead operational readiness.
• Provide site leadership for PAR operations teams including line leaders and operators.
• Ensure staffing is adequate and compliant with safety and quality rules.
• Develop area documentation and support training and operation.
• Investigate deviations and support corrective actions for quality.

Skills

Supervisory experience

cGMP knowledge

Lean Six Sigma

Root cause analysis

Team leadership

Education

STEM degree or certification

Tools

SAP

MES

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

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.

Once the facility is turned over to operations, the Supervisor role is responsible for leadership of PAR operations teams. 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
• 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

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.
• Willingness to work a 12-hour night shift (6pm to 6am on 2-2-3 schedule)

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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $35.33 - $51.83

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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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