Manufacturing Operations Specialist - first shift
The Manufacturing Operations Specialist is a critical hands-on role within Cell Manufacturing. This position is responsible for GMP cell processing operations for adherent and suspension cell cultures. The incumbent will have extreme attention to detail, technical writing skills, and commitment to patients. First Shift - Sunday through Thursday .
Key Duties and Responsibilities:
• Perform clinical product manufacturing for cell therapy according to cGMP standards. Includes assembling raw materials, following specific standard operating procedures (SOP), aseptic technique, completing batch records, reporting deviations.
• Participates and facilitates technology transfer and final process development from the Research to the Manufacturing group. Assists in the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with Research and Quality Systems groups
• Contribute to technical projects both hands-on and documentation
• Perform as SME in some aspects of role
• Ensures raw materials are identified and available in time for manufacturing activities
• Supports Operations group to ensure proper coordination of resources
• Ensures cGMP compliance through consistent execution
• Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking. • Other duties and projects as assign as required to meet departmental requirements
Knowledge and Skills:
• Ability to follow verbal and written instructions
• Ability to generate clear written documentation, including strong technical writing
• Minimum 1 year of experience in a GMP environment
• Minimum 1 year experience with cell culture and demonstration of aseptic technique
• Minimum 2 years working experience in relevant field (may be reduced based on education level)
• Intermediate computer skills, including Word, Excel, Outlook, equipment interfaces and electronic quality systems
• Experience with quality systems
• Works in a cleanroom and office setting
• Must be able to remain in a stationary position 50% during processing activities
• Frequently move about inside the cleanroom to accomplish process tasks
• Occasionally moves lab equipment and materials weighing up to 50 pounds.
• Compressed gasses and LN2 are used in this process
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.