Operations Associate - Parenteral Manufacturing

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

Job summary

A leading healthcare company is seeking an Operations Associate to support the commissioning and validation of a new facility in Concord, North Carolina. This role involves daily performance management, cross-functional collaboration, and the opportunity for significant growth within the company. Ideal candidates will have a background in manufacturing and a strong technical aptitude, along with a commitment to safety and quality.

Benefits

401(k) participation

Comprehensive medical benefits

Flexible spending accounts

Vacation benefits

Employee assistance program

Qualifications

• At least 2 years working within manufacturing/operations.
• Understanding of regulatory agency requirements such as FDA and OSHA.

Responsibilities

• Support commissioning, qualification, and validation of Parenteral areas.
• Ensure cross-functional collaboration to meet key metrics.
• Lead by example with a safety first, quality always approach.

Skills

Communication

Technical Aptitude

Education

Bachelor's degree in a STEM or pharmaceutical related field

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 Parenteral (PAR) 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 PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. The person in this role will be the PAR 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 PAR 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 PAR 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.
• Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
• 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.)
• Aseptic filling, single use assemblies, isolator technology.
• Automated, semi-automated, and/or manual inspection.
• 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.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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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