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 instructions in 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:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Flex Eligibility Status:

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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