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Operations Associate (Sr Specialist, Formulation)

Company: Lilly
Location: Durham
Posted on: November 22, 2021

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 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'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 global healthcare leader headquartered in Indianapolis, Indiana. 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're looking for people who are determined to make life better for people around the world.

At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world's greatest health challenges.

Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility in Raleigh-Durham North Carolina.- This is an exciting opportunity to help build a state-of-the-art facility and Quality System from the ground up.-

Responsibilities:

The Operations Associate (OA) will report to a manager in Parenteral Operations (Formulation).- The OA will be responsible for providing leadership within the area's process team, managing projects and process improvements, acting, as a liaison between operations and multiple functional groups to support event management, change controls, etc.- The OA will also assist the operations team in the day to day management of the production floor and lead investigations and drive implementation of actions associated with deviations.

During the project phase, the Operations Associate will support commissioning/qualification activities required to bring formulation suites into service as well as supporting site operational readiness activities. This position will require domestic travel with the opportunity for international travel based on program need. This role is expected to be a subject matter expert for the formulation process. This role will have the opportunity to be directly involved with hiring and training formulation personnel.

After project phase completion, the Operations Associate is responsible the daily performance management of the process team. This individual must ensure a cross functional collaboration between operations, engineering, quality, supply chain, and maintenance.- The OA will establish and hold the process team accountable for key metrics and deliverables to ensure the process is meeting expectations and actioning improvements for the process. Strict adherence to safety and quality rules and procedures is required. -

Key Objectives

  • Support Site Leadership to build a capable site organization by delivering area operational procedures, quality processes and controls for the Parenteral Manufacturing areas.
  • Monitor and build a strong safety culture
  • Ensure consistency of operations across shifts through active engagement on the shop floor and through Gemba walks and Practice vs. Procedure evaluations.
  • Participates and/or lead cross functional teams in the development and implementation of strategies associated with the area for 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.
  • Lead and facilitate start up activities regarding site operational readiness for the Parenteral portion of the business
  • Lead area tours to support business reviews and / or regulatory audits
  • Trained as a Lead Investigator
  • Development and monitoring of metrics for the area
  • Aid in issue resolution, batch/product approvals, and production schedule execution.
  • Lead specific activities of the process teams.
  • Potential back-up of Manager

    Basic Requirements:
  • Bachelor's degree
  • Experience: 2 to 5 years Operations or Manufacturing Support in Pharmaceuticals
  • Responsible for maintaining a safe work environment, working safely, and accountable for supporting all HSE Goals
  • Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA.
  • Excellent interpersonal, written and oral communication skills
  • Ability to travel up to 100% during Asset Delivery and technical transfer.- Then
  • Previous experience in operations or directly supporting a pharmaceutical manufacturing operation.
  • Ability to work in a controlled environment (classified and non-classified) which requires specific company provided gowning.
  • Previous experience with EMPQ requirements of classified areas and in-operation EM Program
  • Experience with root cause analysis, technical writing / authoring investigations
  • Knowledge of lean manufacturing principles and concepts
  • Advance computer skills are required (Data Analysis - run charts, pareto charts, pivot tables).
  • Strong organizational skills and ability to handle and prioritize multiple requests.
  • Strong technical aptitude and ability to train and mentor others.
  • 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.

    Additional Skills/Preferences:
  • Bachelor's Degree in science, engineering, or technical field
  • Previous experience in facility/area start-up environments
  • Career interests in Operations Leadership
  • Certified Six Sigma Green/Black Belt

    Additional Information:
  • The position is for the Lilly Research Triangle Park site and during the project phase will allow for a flexible working environment will the ability to periodically work remotely based on the project phase and site activities.
  • Position may require a short duration assignment of 2-6 months in Indianapolis, IN to establish specific device knowledge, establish global contacts, and provide production support. Additionally, this position may require short (less than 1 month) international travel to support Factory Acceptance Testing of equipment.
  • Must be flexible to attend meetings or support off-shifts (operations is 24/7)
  • Ability to wear safety equipment (safety glasses, safety shoes, protective gloves etc.)

    Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

    As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. - If you would like to request an accommodation for medical or religious reasons, you may do so at workplace_adjustment@lilly.com. -

Keywords: Lilly, Durham , Operations Associate (Sr Specialist, Formulation), Other , Durham, North Carolina

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