Celgene Associate Director, CAR-T Warehouse Operations in Summit, New Jersey
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.
Supply Chain Operations
Purpose of the Position:
The Associate Director, CAR T Warehouse Operations leads a team managing all processes associated with material receipts, movement, storage and distribution within CAR T clinical and commercial operations. This position plays a strategic role in the CAR T warehousing processes ensuring appropriate controls and efficient operations. The Associate Director leads multiple warehouse supervisors and material handlers across multiple warehouse locations and multiple shifts. As a member of the CAR T Supply Chain Operations leadership team, collaborate with internal and external stakeholders to meet objectives and goals.
Build, maintain and lead a high achieving organization to support late phase clinical trial and commercial CAR T warehousing activities
Manage daily operational activities associated with kitting, receiving of Apheresis and PBMC shipments, all movement of materials through the CAR T supply chain network and preparation of drug product shipments
Engage in various groups to manage and expedite receipt along with ensuring appropriate sampling / inspection of incoming materials
Work with CAR T Materials Management Organization to build short and long-term capacity models for all warehouse space requirements including controlled room temperature, refrigerated and freezer storage
Develop staffing models and personnel requirements to ensure department is appropriately staffed to meet all short and long-term capacity requirements
Ensure development, implementation and maintenance of appropriate training curricula
Manage the creation, implementation and compliance for all documentation, procedures and policies
Lead and manage the development of corrective and preventative actions, deviation responses and investigations for warehouse operations
Efficiently coordinates, communicates, and provides essential Warehouse Operations project information and activities status to Development, Clinical, Planning, Manufacturing, Quality Assurance, Global Supply and other associated functions in a timely manner without becoming the critical path
Identify strategic and operational issues both internally and externally, develop proposals, outline solutions, and provide time commitments and resources
Lead multi-functional and multi-location teams through project identification and implementation
Act as a change agent in a fast-paced environment to promote flexibility, creativity, and accountability
Build a collaborative environment that fosters decisive decision making and accountability
Build trust and productive relationships with peers and stakeholders
Deliver business results through timely and quality decision making
Fosters a culture of high ethics and compliance
Promote a mindset of continuous improvement, problem-solving and prevention
Create an environment of teamwork, open communication, and a sense of urgency
Drive collaboration across the company and external partners
Develop, maintain and actively manage relationships with customers and external partners to ensure optimize total cost of ownership
Provide a safe and healthy work environment for staff within areas and ensure compliance with all appropriate policies and regulations
Develop business continuity plans to ensure sustainable operations
Develop dashboard to monitor performance against metrics and KPIs
Required Competencies-Knowledge, Skills, and Abilities:
Advanced knowledge of cGMP/GDP/Pharmaceutical regulations
Advanced knowledge warehouse operations including best industry practices, application of principles, concepts, practices, standards, validation and qualification
Proficiency in ERP systems / WMS Applications and analytics tools
Advanced proficiency in MS Office applications
Advanced analytical, problem-solving, and critical thinking skills
Advance project management experience handling multiple projects simultaneously
Advanced written and verbal communication skills
Advanced presentation development and delivery skills
Advanced organizational and time management skills
Ability to travel 10% - 20% of time
Education & Experience:
Bachelor’s degree in supply chain, engineering, life sciences, information systems, business management or related fields; advanced degree preferred.
15+ years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.
7+ years experience in warehousing, manufacturing and supply chain areas.
Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
An equivalent combination of education, experience and training may substitute.
Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
Physical dexterity sufficient to use computers and documentation.
Sufficient vision and hearing capability to work in job environment.
Ability to lift up to 25 pounds.
Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet.
Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
Flexibility to don clean room garments and personal protective equipment (PPE).
Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
Routine exposure to human blood components.
Designated areas may prohibit food, any outside materials such as cell phones, tablets, at a minimum.
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.
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.