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SalaryJob Description
Description:
The Manufacturing Operations Specialist will lead and assist in the day-to-day Manufacturing Operations at the Leiden Center 1 (LC1) facility. The incumbent will be working in the Clinical Manufacturing facility under a GMP environment supporting aseptic operations inside a BSC and assisting others in various tasks ensuring continuous manufacturing production. 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, dedication to patients, and drive to learn and ability to lead a team along with training their peers.
This role requires the understanding of and strict adherence to cGMP requirements for cell processing operations involving adherent and suspension cell cultures. The successful candidate will read and interpret Batch Records, SOPs, policies and other relevant work instructions to ensure successful and compliant drug substance manufacturing. In this role, you will also collaborate with Facilities/Operations, Quality, EH&S, Materials Management and related stakeholders to drive efficient Manufacturing Operations.
The schedule for this role is First Shift (7AM – 4PM)
Work shift is Sunday – Thursday (40hrs)
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.
- 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.
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
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
Education and Experience:
- High School degree and/or 3+ years of experience, or the equivalent combination of education and experience in a related field
- Ability to follow verbal and written instructions in English
- Solid communication and documentation skills
Company Information
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.
