Celgene Associate Director, QC Operations - CAR-T - CTD 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.

Associate Director, QC Operations - CAR-T - CTDWarren, NJ

SUPERVISOR

Executive Director, Clinical Production and Supply

DEPARTMENT

Quality Control, Cell Therapy Development (CTD)

PREREQUISITES

BS/ MS degree in Biology, Biotechnology, Biomedical Engineering (or a related study) and 8-10 years related Biotech/Pharmaceutical industry experience preferred.

Summary

Oversees all quality control functions (microbiology, analytical testing, stability testing, and equipment maintenance) for clinical cell therapy products produced at Celgene’s CTD Warren Facility. Responsible for ensuring clinical raw materials, intermediates, and final products meet acceptance criteria and conform to regulatory filings. Also, responsible for ensuring analytical and microbial methods comply with applicable regulations and industry standards.

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

  • Defines group goals/objectives/milestones and assures alignment with other CTD functions. Assures department functions within approved budget and performance and quality standards.

  • Directs QC operations, including:

  • Raw material acceptance/testing

  • Environmental monitoring

  • Intermediate and final product testing

  • Equipment validation and calibration

  • Microbiology testing

  • Execution of product stability studies

  • Responsible for maintaining the appropriate staff (headcount and skills) to meet functional goals in an efficient and effective manner, within departmental budgets. Ensure personnel are properly trained and qualified for their assigned tasks.

  • In partnership with development teams, defines product testing strategies (sampling and methods) and authors related regulatory submission documents. Including attribute, microbial, and stability testing of raw material, intermediate, and final products.

  • Maintain current awareness of GMP/GTP and other regulations, guidance documents, advisory committees, industry standards and trends that are applicable to CTD operations and products.

  • Ensures department procedures and protocols are maintained current and are properly implemented.

  • Ensures daily completion of all incoming or assigned workload in all QC laboratories. Oversees all daily operations by the staff in the above areas, and coordinates with assigned MO staff.

  • Maintains operations in compliance with Celgene Quality Systems and Federal Regulations (i.e., cGMPs). Assists in preparation for audits and inspections. Responsible for departmental review of all Non-Conformances, investigative reports and CAPAs.

Skills/Knowledge Required:

  • Requires BS or MS degree in Biology, Biotechnology, Biomedical Engineering (or a related study) and eight (8) to ten (10) years related Biotech/Pharmaceutical industry experience preferred.

  • Must have thorough understanding of cGMP requirements for the production and testing of clinical materials.

  • Must be able to interpret technical and quality documents, such as protocols, development reports, change requisitions, non-conformance investigations, batch production records, safety procedures and standard operating procedures (SOPs).

  • Must have excellent management and communication skills, and be able to manage technical staff

  • Must be able to communicate effectively with development personnel, medical staff, and regulatory agencies.

  • Should have good computer skills.

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.