Process Engineer, CAR-T | BioNJ Talent Services

Process Engineer, CAR-T

Contact Information
Contact Name: 
CELGENE
Organization Name: 
CELGENE
Position Location: 
Summit, NJ
Company Profile: 

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:

PREREQUISITES

Experience in biologic/vaccine manufacturing support, tech transfer, and validation

Position Summary

The Process Engineer CAR-T Process Engineering and Technology Support is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Collaborates with SME from the Development Group, Manufacturing Group, and Quality Group while providing technical support for the resolution of process deviations, the evaluation and implementation of process changes and continuous improvement 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
•Interface with operators and serve as process SME. Learn the procedures, analytics and document any known sensitivity.
•Continuously monitor, analyze, and optimize the end-to-end process and anticipate and permanently resolve issues that may arise during production
•Provide technical input and investigation support for production related investigations, ensuring compliance with internal standards and regulatory requirements
•Design and execute test plans and other risk mitigation exercise as part of investigations (e.g. Root cause analysis and CAPAs)
•Sponsor and support the change initiatives and the implementation of process improvement initiatives
•Work closely with Engineering /Maintenance 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)
•Interact with other teams including Validation, Development, Operations, QA and Regulatory
•Interface with regulatory authorities as required to support Manufacturing Operations audits
•Lead project teams, prepare project schedules, coordinate the execution of technical projects and develop presentations to disseminate results to project stakeholders and senior management
•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 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

Leadership:
•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

Qualifications: 

Skills/Knowledge Required:
•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)
•5 or more years of manufacturing support or related experience in the biopharmaceutical industry

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.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
BioTech
Job Reference: 
Req #: 1801114
Paid: 
Yes