Manufacturing Operations Senior Associate, 1st Shift, Wed-Sat

Job Description

The Manufacturing Operations Senior Associate will assist in the day-to-day manufacturing operations at the Leiden Center 1 (LC1) facility. Under supervision, the Senior Associate will work in a Clinical Manufacturing facility performing aseptic operations in a GMP environment. The Manufacturing Operations Senior Associate is a critical hands-on role within cell manufacturing. This position is responsible for GMP cell processing and sterile filling operations. The successful candidate will have extreme attention to detail, dedication to patients, and drive to learn.

This role requires the understanding of and strict adherence to cGMP requirements for cell therapy bioprocessing operations. 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 work schedule for this role is 4x10, First Shift (7 am - 5:30 pm)

Working days are Wednesday - Saturday (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.

• 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.

• 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 instructionsin English

• 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 diploma and 3 years of experience, or the equivalent combination of education and experience in a GMP environment

• Strong communication and documentation skills

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

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