Celgene Manager, QC Validation 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.

QC Validation Manager CAR-TSummit, NJ

  1. Purpose and Scope of Position

The QC Validation Manager is responsible for instituting and overseeing the validation and ongoing maintenance of methods associated with CAR-T products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, author protocols/reports, and troubleshoot. Additionally, this position will be responsible for training and may participate in assay transfer.

  1. Required Competencies: Knowledge, Skills, and Abilities
  • Advanced hands on experience with various analytical techniques including: flow cytometry, PCR, and other immunoassays.

  • Advanced ability to accurately and completely understand, follow, interpret, apply Global

Regulatory and cGMP requirements.

  • Advanced ability to interact with regulatory auditors as Subject Matter Expert (SME).

  • Advanced technical writing skills.

  • Advanced problem-solving ability/mentality, technically adept and logical.

  • Ability to represent the interests of the group on cross-functional teams.

  • Ability to set priorities of the group and manage timelines.

  • Ability to work with management locally and globally.

  • Advanced knowledge of data trending and tracking, including use of statistical analysis software.

  • Advanced ability to communicate effectively with peers, department management and cross- functional peers.

  • Working knowledge of change control processes.

  1. Duties and Responsibilities
  • Utilize advanced scientific principles to assist in the authoring of analytical testing methods and the proper use of laboratory equipment.

  • Capable of handling complex issues and solving problems with minimum guidance.

  • Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.

  • Generate and present statistical tables summarizing trends, outliers, etc. of stability data

  • Author Stability protocols and reports.

  • Ensure appropriate change controls are completed for method changes/updates.

  • Effectively communicate method changes/updates to lab personnel; ensure lab personnel are appropriately trained on changes/updates.

Drive and Manage projects within the group

  • Accepts responsibility for group projects; designs and executes experiments, analyzes results, and writes technical summary reports.

  • Capable of handling complex issues and solving problems with minimum guidance.

  • Prepare and present continuous improvement projects to management.

  • Comprehensive understanding of guidelines and can independently develop, write and execute method, protocols, reports, and other related documents.

  • Assist management with investigations and deviations.

Carry out management authority for review and approval activities

  • Serve as author or technical reviewer of appropriate departmental procedures.

  • Review documentation as required by laboratory procedures.

  • Perform approvals for relevant laboratory activities.

  1. Education and Experience
  • Requires a Bachelor’s Degree in Biochemistry, Immunology, Molecular and Cellular Biology, or Biology

  • Advanced Degree preferred.

  • 7-10 years of relevant work experience, preferable in a regulated environment.

  • Previous experience in a gene or cell therapy facility is preferred.

  • An equivalent combination of education and experience may substitute.

  1. Working Conditions
  • The incumbent must analyze numerical values on a daily basis.

  • The incumbent will be working a laboratory setting up to six (6) hours per day.

  • The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

#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.