Operations Associate - Device Assembly and Packaging

Initial Therapeutics, Inc.; Concord (NC); On-site; USD 64,000 - 141,000; Full time

Job summary

An established industry player is seeking an Operations Associate to contribute to a groundbreaking facility in Concord, North Carolina. This role offers a unique opportunity to influence team culture and operational readiness while ensuring safety and quality in the production of life-changing medicines. As a technical expert, you will lead initiatives in training, process excellence, and continuous improvement, collaborating across functions to achieve key performance indicators. Join a dynamic team dedicated to making a real difference in healthcare and enjoy significant growth opportunities in a supportive environment.

Benefits

401(k) Plan

Pension Plan

Vacation Benefits

Medical Benefits

Dental Benefits

Vision Benefits

Flexible Spending Accounts

Life Insurance

Employee Assistance Program

Fitness Benefits

Qualifications

• Bachelor's degree in a STEM or pharmaceutical related field required.
• 2+ years of experience in manufacturing/operations preferred.

Responsibilities

• Support commissioning and validation of Device Assembly and Packaging areas.
• Lead operations readiness programs and ensure cross-functional collaboration.

Skills

Communication Skills

Technical Aptitude

Continuous Improvement Methodologies

Root Cause Analysis

Regulatory Knowledge (FDA, EMEA)

Education

Bachelor's degree in STEM or pharmaceutical field

Tools

Manufacturing Execution Systems

Data Analysis Tools

Documentation Management 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 Description

Company Overview

At Lilly, we unite caring with discovery to make life better for people around the world. We are a 140+ year strong global healthcare leader headquartered in Indianapolis, Indiana with manufacturing sites throughout the US, EU, and Asia. Our 35,000 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 are looking for people who are determined to make life better for people around the world and embody our company values of Integrity, Excellence, and Respect for People.

Position Overview

Lilly is investing over $1 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, parenteral operations, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need.

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

During the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of the Device Assembly and Packaging (DAP) areas as well as lead/assist in operations readiness programs (e.g. Material procurement and definition, training programs, process excellence, continuous improvement, and capacity planning). The person in this role will be the DAP area’s technical subject matter expert and will be involved in hiring and training personnel. This position will require travel domestically 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 OA role is responsible for daily performance management and support of the DAP process team. This individual must ensure cross functional collaboration between operations, engineering, quality, supply chain and maintenance to meet key metrics and deliverables for the area. Above all else, the role will lead by example with a safety first, quality always approach.

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

Key Objectives / Deliverables

Integrity

• Lead by example 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.
• Lead/conduct area deviation and corrective action discussions as a lead investigator 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.

Excellence

• Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations.
• Lead and facilitate operations readiness activities and programs for the DAP portion of the business which include consumable and supplies definition and procurement, training resource development, GMP documentation creation, and management of people, materials, product flows throughout the facility.
• Participate 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).
• Understand and influence the manufacturing control strategy for their area.
• Develop, monitor, and propose solutions to improve or meet key performance indicators (KPI) for the area.

Respect for People

• 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.
• Lead area tours to support business reviews, regulatory audits, or network collaboration.

Requirements (Education, Experience, Training)

Education, Experience, and Capabilities

• Bachelor's degree in a STEM or pharmaceutical related field of study.
• At least 2 years working within manufacturing/operations.
• Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA, or other similar groups.
• Excellence in electronic, written, and oral communication skills.
• Strong technical aptitude as demonstrated through previous work or educational accomplishments.

Time Commitments, Environment, and Work Authorization

• Ability to wear safety equipment (glasses, shoes, gloves, etc.).
• Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives.
• 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.
• Travel domestically and internationally, up to approximately 20% of the year to learn and network with colleagues.

Preferred attributes but not required

Experience with or understanding of:

• Working within or directly supporting pharmaceutical, food, packaging, or applicable manufacturing departments.
• Highly automated equipment (inspection, filling, device assembly, packaging, etc.).
• Advanced computational capabilities (e.g. Data Analysis, Pareto and Control charting, Trending and computing with multiple variables).
• Technical writing such as creation of standard operating procedures, work instructions, and training documentation.
• Facility, Equipment, Systems Start-up.
• Equipment design, qualification, and process validation.
• 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).

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $64,500 - $140,800. 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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