Celgene Operations Excellence Engineer II, CAR T in Summit, New Jersey

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

SUPERVISOR

Senior Manager Operations Excellence, CAR-T, Lean Six Sigma Black Belt

PREREQUISITES

Experience in application of Lean, Six Sigma and Change Management principles in biologic, vaccine, or other GMP/FDA manufacturing operations

Position Summary

Operations Excellence Engineer II ,CAR-T is responsible for performing functions to apply techniques and principles that will improve the end to end operations and supply chain process that will deliver best in class safety, quality, productivity and cost across the BB2121 value stream. This position is intended for someone with organizational curiosity and will think beyond the current status quo. Using lean/six sigma techniques, the person in this role will drive improvements both individually and through cross functional teams for cell therapy products for both global clinical trials and commercial supply.

The Operations Excellence Engineer II will require knowledge and experience in conducting time studies, mapping value streams, and preparing estimates of labor and material costs associated with proposed changes as well as other process inputs to recommend changes that lead to improvements and work closely with stakeholders to, recommend, and /or execute improvements

Responsibilities include, but are not limited to, the following:

  • Evaluate and establish processes and systems with the goal of improving product quality, throughput/capacity reduce costs, and/or reduce lead-time and cycle times.

  • Establish key performance metrics to drive operational stability and predictability and create predictive analytics and models to achieve future desired operational capability and growth

  • Identifies required resources including personnel, tooling, equipment, facilities, work-in-process and production

  • Create and maintain capacity models, simulation models, and proactively drive capacity solutions

  • Establishes work measurement programs and analyzes work samples to develop labor standards

  • Analyzes work force utilization, facility layout, and operational data such as production costs, process flow, headcount and production schedules, to determine efficient utilization of worker and equipment

  • Support project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management

  • Recommends methods for improving efficiency and reducing waste of raw materials and utilities.

  • Design and facilitate workshops to understand current processes, conduct route cause analysis investigation, design future state and develop change plans

  • Conduct Gemba style process documentation and diagnostic activities

  • Collect, consolidate, and analyze data and information, present it in a format that brings information to life and therefore supports effective decision making

  • Work across all levels, from business leaders to front-line staff, to identify business impacts and support the development of change plans

  • Create and modify material to support knowledge transfer, implementation and training

  • Participate in team meetings and contribute to the development of Process Excellence tools and methods

  • Run internal projects (e.g. Project initiation, planning, scope, funding requests, approvals, execution and closeout)

  • Direct multidisciplinary project teams to ensure delivery of the project on time, on budget and to pre-defined quality level. Prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate progress, risks and status to project stakeholders and senior management

  • Work closely with Engineering /Maintenance on the design and implementation of new technology and new systems/facilities related to production process needs

  • Sponsor and support the change initiatives and the implementation of process improvement initiatives

  • Foster strong inter-team relationships to achieve common project goals

  • Interface with operations and serve as Operations Excellence SME

  • Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production

  • Provide investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements

  • Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)

  • Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities

  • Support inspection readiness and actively support regulatory inspections and ensure safe and compliant cGMP operations

  • Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records)

  • Interact with other teams including Validation, Development, Operations, QA and Regulatory

  • Support Senior Operations Excellence Manager in accomplishing productivity and financial goals with the cross-functional team

  • Support the tracking of team metrics and manage completion of objectives and projects

  • Participate in routine plant operating meetings

Leadership:

  • Promote a mindset of continuous improvement, problem solving, and prevention

  • Create an environment of teamwork, open communication, and a sense of urgency

  • Support the change agent in promoting flexibility, creativity, and accountability

  • Support organizational strategic goals and objectives that are linked to the overall company strategy

  • Drive strong collaboration within the plant and across the network

  • Build trust and effective relationships with peers and stakeholders

  • Deliver business results through timely and quality decision making and advice

  • Foster a culture of compliance and strong environmental, health, and safety performance

Skills/Knowledge Required:

  • Four-year Degree in Industrial Engineer/Manufacturing Engineer or related field

  • Successful and demonstrable track record delivering end-to-end (from conception to benefits realization) process improvement initiatives

  • Experience with application of Operational Excellence and Lean Manufacturing principles

  • Preferred Lean/Six Sigma Green Belt Certification from accredited institution (e.g. ASQ)

  • Experience with Project Management and Change Management principles

  • Knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations

  • Experience working with external parties and/or leading cross-functional teams

  • Possess strong verbal/written communication skills and ability to influence at all levels

  • Ability to think strategically and to translate strategy into actions

  • Ability to prioritize and provide clear direction to team members in a highly dynamic environment

  • 3 or more years of manufacturing support or related experience in the biopharmaceutical industry

#LI-POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE

At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.