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.
Come and join Celgene for this key leadership role to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies. At Celgene, we are developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. This role will report to the Vice President of Cell Therapy Global Manufacturing Science and Technology, the Head of global Packaging and Labeling validation is a key leadership role within Celgene's Cell Therapy Development and Operations (CTDO) Division.
This senior leadership role is responsible for packaging, labeling lifecycle management and shipping validation. The scope will range across all cell therapy products in the portfolio and include packaging, labeling, and shipping solutions and strategies used in internal and external manufacturing facilities for plasmid, viral vector and drug product. The leader will develop, implement and maintain global policies, standards, and systems, establishing a global strategy and framework for cell therapy packaging, labeling, and shipping validation and continuous verification. They will also maintain the systems and processes for label content creation, review, and approval.
The head will develop a team of technical experts who understand cell therapy packaging, labeling and shipping requirements to develop fit for purpose solutions and scientifically sound validation strategies. This team will also support validation activities needed during design of new products to make sure packaging, labeling, and shipping approaches consider our harmonized validation framework that is complaint with global health authority expectations and is scientifically sound. The leader should develop a team with strong technical background allowing flexibility to leverage this team to support the broader project portfolio within MSAT. Leading this team, the successful candidate will be responsible for the management of packaging projects, creation/revision of engineering documentation (specifications, protocols, reports), and management of external resources required to support the production of personalized cell therapy products for both global clinical trials and commercial supply.
This leader is expected to work across various CTDO functions, internal and external manufacturing sites and collaborate closely with Process Development, Quality, Clinical R&D, and Regulatory functions to shape the validation program and policies that are harmonized and defendable with the global health authorities. Furthermore, the head of Packaging and Labeling validation will interface with the packaging, labeling, and shipping validation counterparts in the Celgene Biologics and small molecule network to leverage expertise and knowledge across modalities. Candidate is expected to participate and network in the external industry forums and conferences to influence and contribute to the evolution of cell therapy packaging, labeling, and shipping validation practices.
Major job duties include:
+ Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry practices for cell therapy.
+ Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to cell therapy production.
+ Develop packaging, shipping and labeling solutions to enable product registration and through the product lifecycle as new manufacturing sites or process/product changes are introduced
+ Responsible for the technical elements of the end to end label process in cell therapy and are the process owner for product labeling content development and approval
+ Lead, develop and implement the validation plans for packaging, labeling, and shipping solutions, in collaboration with the validation and technical SME network.
+ Develop storyboards and present Celgene's global validation framework, standards and approaches during major health authority inspections.
+ Shape and review the technical content in the validation sections of the dossier
+ Provide validation expertise for issue resolutions to support deviations or CAPAs and audit findings
+ Develop/approve cGMP documents including, but not limited to, Validation Plans, protocols.
+ Collaborate with QA to monitor and respond to audit observations related to GXP regulations
+ Work with MSAT network, to assess impact of changes to packaging, labeling, and shipping solutions validated state
+ Supervise and mentor a team of validation engineers and professionals and enable their individual growth
+ Establish performance goals and strategic/operational objectives for direct reports
+ Track department performance metrics and provide progress reports to stakeholders
+ Design qualification strategies to support novel applications of packaging, labeling, and shipping solutions
+ Partner with Quality Assurance to maintain high standard of compliance in all program deliverables.
+ Work closely with process and analytical development and MSAT network during characterization and validation stages of the late stage development to ensure that the packaging, labeling, and shipping validation strategy is consistent with our overall strategy
+ Bachelor's degree in a life sciences or Chemical Engineering discipline and a minimum of 15 years of relevant biotechnology or pharmaceutical industry (operations, technical development, MSAT)
+ 10+ years of direct experience in GMP validation activities, and 7+ years of people management
+ Proven record with successfully managing validation programs in support of GMP packaging, labeling, and shipping solutions
+ Experience leading regulatory inspections regarding validation
+ Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations
+ experience with Quality Management System (e.g. Deviations, CAPAs, Change Management)
+ Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent
+ Excellent written and verbal communication skills at all levels in the organization
+ 2-3 years of experience in cell therapy technical operations
+ Combination of experience in MSAT and quality.
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 acc