Senior Manager CAR T Supply Chain Operations - Summit , New Jersey, United States, 07901
Location: Summit, New Jersey, United States
Job Category: Technical Development
Work Location: 556 Morris Avenue 07901
Employee Status: Full-time
Job Type: Regular
Purpose and Scope of Position
The Senior Manager, CAR T Supply Chain Operations is responsible for the coordination, communication and support of various projects, process mapping and data within the department. The position will manage and coordinate Global Change Control, Deviations & CAPAs across the department. The scope of work includes analytical and documentation responsibilities across the Process & Technology, Warehouse and Material Management departments to maintain a compliant, effective and efficient operation that meets or exceeds site goals and objectives.
Required Competencies: Knowledge, Skills, and Abilities
- Advanced proficiency in data analytics and process mapping applications (Excel, Visio, Sharepoint)
- Advanced proficiency in desktop applications (Powerpoint, Word, Outlook)
- Advanced knowledge in process mapping and documentation
- Advanced written and verbal communication skills
- Advanced presentation development and delivery skills
- Problem-solving aptitude with attention to detail
- Thorough knowledge of cGxP regulations
- Understanding of cell culture, cryopreservation, purification, and aseptic processing or lab technique
- Ability to work independently for extended periods of time
- Ability to work collaboratively as a team member
- Ability to interpret / write technical documents
- Ability to gown into Grade C and D classified environments
- Ability to travel
Support Site Supply Chain Operations Organization in collecting and analyzing data to improve processes, reporting and communication. Develop and create communication plans across departmental areas. Manage activities and project milestones to implement changes and improvements. Manage Site Supply Chain departmental CAPA & Deviation quality systems elements in conjunction with operations and quality groups.
CAPA & Deviation Management
- Collaborate with cross-functional system partners and represent the Site Supply Chain Organization in all CAPA & Deviation reviews and communication.
- Investigate events and effectively prepare communication to address questions and issues.
- Leads internal organization and project teams to advance departmental quality matters (including but not limited to deviations, CAPAs, change control evaluations).
- Critically review investigations, interpret results and work with SMEs to generate conclusions consistent with quality risk management principles.
- Develop business process models, process maps, process outlines and documentation to assist in evaluating and optimizing business operations.
- Seek and support continuous process improvement projects both within the department and across site collaborative initiatives.
- Collaborate with site and departmental management to develop business requirements for business process improvements within site operations.
- Manage projects across all of site supply chain operations.
- Performs business impact assessment on changes to business systems (ERP, MES, boundary systems) and processes.
- Understand manufacturing processes and the implementation within the global ERP and boundary systems (i.e., configuration and master data, including, but not limited to, items, recipes, routings, formulas, process instructions and process variables).
- Collaborate internal and external departments to gather business requirements, prioritize, develop, design, create data source definitions and deliver reports from ERP or Ad Hoc reporting tool(s).
- Collects, analyzes and reports key information impacting the site supply chain operations.
- Collaborate with departmental leads to create, manage and publish KPIs and metrics.
- Lead the development of a communication plan that keeps internal stakeholders appropriately informed of departmental initiatives and progress reports.
- Create and manage departmental sharepoint sites to facilitate collaboration and communication across Cellular Therapy Organizations.
- Bachelor s degree from an accredited college or university required . Advanced degree preferred. (Engineering or Supply Chain Degree preferred)
- 10+ years of relevant work experience required, preferably in the pharmaceutical or related industry.
- 4+ years of leadership experience preferred.
- 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.
- 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 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.
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.
Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain