Celgene Manager, Quality Control Operations CAR-T Mfg Cell Therapy in Warren, 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.

Manager, Quality Control Operations CAR-T Mfg Cell TherapyWarren, NJ

Requires Cell Therapy Experience.

DEPARTMENT

Quality Control, Cellular Therapeutics Division

PREREQUISITES

B.S. or M.S. in Biology or related discipline

Summary:

The Manager, Quality Control works both independently and with the team to manage the general operation and workflow of the QC laboratory or function and performs routine testing and analytics, when necessary.

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

  • Working independently, carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.

  • Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.

  • Influence routine testing strategies and sampling requirements in support of regulatory submissions for Flow Cytometry, PCR, and ELISA.

  • Manage general laboratory operations on a day to day basis within the assigned area of responsibility.

  • Responsible for maintaining the laboratory test schedule and delivery of results within established batch release timelines.

  • Perform duties of a Qualified trainer and assist department Management with employee training, qualification and professional development.

  • Identify, interview, and hire new team members and think strategically on long-term departmental growth.

  • Prepare employee task assignment schedules and allocation of resources to execute department required activities in support of operations.

  • Ensure that schedules coordinate with other operations across both QC and Manufacturing, where necessary.

  • Document laboratory test results on worksheets utilizing Good Documentation Practices.

  • Identify and execute Continuous Improvement Projects for the department. Lead and develop best practices in the laboratory.

  • Using technical expertise troubleshoot and solve problems that may come up in the day to day operation of the department.

  • Capable of leading local cross-functional and Global teams, as required.

  • Perform Final Review of critical cGMP documents supporting batch release and controlled area status.

  • Author and Revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols in support of projects.

  • Initiate and perform Deviation Investigations/CAPA’s

  • Interface with Regulatory Agency Inspectors/Auditors

Skills/Knowledge Required:

  • B.S. in Biology or related discipline with 7-9 years of relevant experience or M.S. with 5-8 years of relevant experience preferred.

  • Experience working with cell therapy products such as CAR-T is preferred.

  • Experience managing teams.

  • Excellent organization skills and ability to handle multiple tasks of significant complexity.

  • Highly motivated, drive to acquire new skills.

  • Independently recognize problems and able to recommend and develop solutions from broad experience, literature or collaboration.

  • Ability to organize priorities related to own work. Communicate and use this information to increase productivity.

  • Expertise in mammalian cell culture and diverse analytical techniques.

  • Experience working in a regulated environment.

  • Excellent verbal and written communication skills

  • General knowledge or assay or equipment validation

Please visit www.celgene.com to learn more about current opportunities at Celgene. To apply for this position, please visit the career section.

  • Celgene Corporation is an equal opportunity employer.

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.