Other Locations:US- NJ- Summit West
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.
Experience in biologic/vaccine manufacturing support, tech transfer, and validation
The Manager CAR-T Process Automation is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. The Manager Process Automation is responsible for managing activities and personnel associated with design, development, delivery, validation, maintenance and support of GxP computerized systems. He/She collaborates with SME from the Process Engineering & Support, Manufacturing Group, and Quality Group to ensure automation requirements are satisfied in support to the production operations to ensure rapid, flawless, compliant, and cost-effective delivery of quality products.
Responsibilities include, but are not limited to, the following:
- Ensure safe and compliant cGMP operations
- Maintain permanent inspection readiness and actively support regulatory inspections.
- Promotes and enforces standard systems, policies and procedures across the full range of systems being managed.
- Implement and maintain the site and global policies for System Management and Administration, aligning with Celgene Corporate GxP system processes. Coordinate with Celgene IT and other sites on standardization of system lifecycle management in terms of implementation, support, validation, service, change management and system data requirements from a local and global perspective.
- Oversees the design, delivery and commissioning of GxP computerized systems.
- Support change initiatives and the implementation of process improvement initiatives by assessing the impact to the validated state of the automation.
- Work closely with Process Engineering and Support on the design and implementation of new technology and new systems/facilities related to production process needs.
- Review and revise the content of technical documentation (e.g. investigations, changes, SOPs and batch records) ensuring compliance with validated state of the automation.
- Interact with other teams including Process Engineering and Support, Development, Operations, QA and Regulatory to provide technology guidance that enables and support future plans and strategies.
- Interface with regulatory authorities as required to support Manufacturing Operations audits.
- Applies a high level of understanding of pharmaceutical manufacturing and lab processes, procedures, controls and GMP requirements.
- Applies an overall understanding of process automation, information management systems, laboratory management systems, vendor quality management, infrastructure management, maintenance and metrology used in manufacturing and laboratory environments.
- Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
- Foster strong inter-team relationships to achieve common project goals.
- Support Sr. Director in accomplishing productivity and financial goals with the cross-functional team.
- Support the tracking of team metrics and manage completion of objectives and projects.
- Participate in routine plant operating meetings.
- Create an environment of teamwork, open communication, and a sense of urgency
- Support the change agent in promoting flexibility, creativity, and accountability
- Support organizational strategic goals and objectives that are linked to the overall company strategy
- Drive strong collaboration within the plant and across the network
- Build trust and effective relationships with peers and stakeholders
- Deliver business results through timely and quality decision making and advice
- Foster a culture of compliance and strong environmental, health, and safety performance
- Promote a mindset of continuous improvement, problem solving, and prevention
- Expert knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy regulations
- Deep knowledge of facility/clean room design, process, equipment, automation, and validation
- Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities
- Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies
- Experience working with external parties and/or leading cross-functional teams
- Possess strong verbal/written communication skills and ability to influence at all levels
- Ability to think strategically and to translate strategy into actions
- Ability to prioritize and provide clear direction to team members in a highly dynamic environment
- Experience with Operational Excellence and Lean Manufacturing
- Bachelor’s Degree required (science or engineering is preferred)
- 7 or more years of manufacturing support or related experience in the biopharmaceutical industry
- 2 or more years of leadership experience required
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.