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.
This Continuous Improvement Manager is responsible for the continuous improvement efforts related to cell and gene therapy processing activities within the GMP manufacturing suite. This individual works collaboratively with manufacturing, development, and quality teams to develop extensive knowledge of cell culture processes and compliance requirements. The Associate Manager is accountable for the timely resolution of investigations and drives proactive and corrective improvements within the operation.
Responsibilities will include, but are not limited to, the following:
" Has responsibility and oversight of the deviations, change requests, CAPAs, and document revisions, from a manufacturing perspective, in the Quality Management Systems.
" Develops and maintains systems to capture operational data capable of being used to detect trends, confirm process controls, and generate reports for senior management.
" Promotes cross-functional continuous improvement efforts and structured problem solving activities that aim to reduce or eliminate waste and errors in work processes.
" Performs investigations of deviations that arise from the processing laboratories by interviewing operators, collecting facts, determining root cause, and writing defendable conclusions.
" Build and manage the Manufacturing Investigative team at a pace appropriate for keeping up with production capacity by recruiting, training, and mentoring individuals.
" Develops and implements reasonable and effective corrective and preventative action plans.
" Acts as a liaison between manufacturing and quality teams to expedite review and approval of action items in our quality management systems to prevent overdue items and remain in compliance.
" Performs training of applicable personnel when improvements are implemented.
" Identifies areas needing improvements by evaluating and reporting on key performance metrics.
" Prepares, distributes & presents investigation status reports to team members and management.
Knowledge And Skills:
" B.S. in a scientific, engineering, or business discipline with 5+ years relevant experience, preferably in a GMP or regulated environment. Understanding of and ability to apply the regulations associated with 21 CFR 210/211.
" Knowledge of internal quality systems including Oracle ERP, Celdox, eQRMs, and eRexS
" Strong understanding of contemporary problem solving tools and techniques.
" Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.
" Has the ability to think creatively and proactively propose solutions with an attention to detail.
" Ability to effectively communicate issues and ideas with peers and with management.
" Ability to build effective working relationships throughout the organization.
" Ability to facilitate meetings with cross-functional teams.
" Ability to operate independently within a tight deadline environment.
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.
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