Celgene Product Quality Lead 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.

Job Description

Job Summary

Celgene is seeking a Product Quality Lead (PQL) for the bb2121 program.

The PQL will provide quality oversight of the bb2121 program from late clinical development phase through commercialization and entire lifecycle. As the product quality expert, the PQL will develop the strategy to proactively minimize product quality risks during product development, technology transfer, and commercial operations. The PQL is the quality liaison between Regulatory Affairs, Development and Operations to ensure regulatory compliance of GMP operations in support of the bb2121 program. The role enables efficient communication and decision making related to the quality aspects of the bb2121 program across the product teams, manufacturing sites and global Cell Therapy functions.

This role is stationed in Summit NJ and reports to the Head of CMC & Commercialization Quality.

Job Responsibilities

  • Provide leadership for the overall product quality plan based on Product Development Team objectives, regulatory commitments, and process and product monitoring KPIs

  • Provide quality expertise in accordance with global regulatory requirements and internal policies in the creation of Product Characterization, Product Specifications, Method Validation, Stability and Comparability assessments for tech transfers

  • Owner of the Global Annual Product Quality Review for bb2121; coordinate with leads of contributing chapters and ensure timely and compliant execution of the program

  • Act as lead quality reviewer of CMC sections of Regulatory submissions and response to global agencies queries; may also author CMC sections or responses to queries, as needed.

  • Represent Product Quality program in CMC meetings with global regulatory agencies and during regulatory inspections

  • Represent Quality in the bb2121 Global CMC and Commercialization teams

  • Lead the bb2121 Product Specification Committee and other product quality related cross-functional teams

  • Act as QA approver for product specifications and product labeling

  • Provide quality oversight and guidance during product launch

  • Provide strategic guidance and facilitate the timely implementation of global changes with respect to the bb2121 product

  • Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase

Qualifications and Education Requirements

  • BS/MS in relevant Science or Engineering discipline and 10+ years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization; 3+ years of experience in a PQL role is preferred

  • Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required

  • Experience with review of market applications, IND, supplements or similar regulatory documentation is required

  • Demonstrated ability in decision making and problem solving is required

  • Demonstrated Quality leadership through partnership in a matrixed-organization is required

  • Background in Biologics or Cell Therapy Manufacturing is required

  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships

  • Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed 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.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.