Operations Manager - Parenteral Manufacturing (Formulation)

Eli Lilly and Company•Concord, NC

1d•$65,250 - $145,200

About The Position

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. Organization 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 Responsibilities: 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/or 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 currently produce our medicines. 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. 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

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.
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.

Nice To Haves

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.
Formulation and material preparation processes.
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)

Responsibilities

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.
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.
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.