Manufacturing Operations Senior Associate (First Shift)
The Manufacturing Operations Senior Associate will assist in day-to-day manufacturing operations of cell therapy products. Under supervision, the Senior Associate will perform the set-up, operation and disassembly of clinical products. The Senior Associate works in collaboration with drug product development teams through all phases of development, process validation and commercialization to understand process requirements and provide feedback on process performance.
Hours for this position are First Shift (7:30 AM - 4 PM). The standard work schedule will be Tuesday – Saturday (40 hours/week).
The Manufacturing Operations Senior Associate 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, dedication to patients, and drive to learn.
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, and reporting deviations.
• Demonstrates and assists others with aseptic technique.
• May participate in technology transfer and final process development from the Development to the Manufacturing group. Occasionally supports the development of Standard Operating Procedures (SOPs) or other documentation for manufacturing in collaboration with Development and Quality groups.
• Ensures raw materials are identified and available in time for manufacturing activities. Transfer raw material inside cleanroom suite using sanitizing reagents.
• 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 assigned to meet departmental requirements.
Knowledge and Skills:
• Ability to follow verbal and written instructions
• Minimum 1 year of experience in a GMP environment
• Minimum 6 months experience with cell culture and demonstration of aseptic technique
• Basic computer skills Word, Outlook, and equipment interfaces
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.