Manufacturing Operations Senior Associate (Contract)

Vertex Pharmaceuticals; Boston (MA); On-site; USD 66,000 - 72,000; Full time

Job summary

Vertex Pharmaceuticals seeks a Manufacturing Operations Specialist to lead day-to-day clinical product manufacturing at the Leiden Center 1 facility in a GMP environment, focusing on cell therapy processing and aseptic technique.

The role requires attention to detail, ability to follow batch records and SOPs, and collaboration with Quality, EH&S, and Development teams to ensure compliant, timely production.

Qualifications

• 1+ year of experience in a GMP environment.
• Experience with cell culture and aseptic technique.
• Solid communication and documentation skills.
• Basic computer skills: Word and Outlook.

Responsibilities

• Perform clinical product manufacturing for cell therapy according to cGMP standards.
• Demonstrates and assists others with aseptic technique.
• May participate in technology transfer and final process development.
• Occasionally supports the development of SOPs or other manufacturing documentation.
• Ensures raw materials are identified and available in time for manufacturing activities.
• Transfers raw material inside cleanroom using sanitizing reagents.
• Supports Operations group to ensure proper coordination of resources.
• Ensures cGMP compliance through consistent execution.
• Demonstrates Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Collaboration; Drive Breakthrough Results; Promote Enterprise Thinking.
• Other duties and projects as assigned.

Skills

GMP experience

Aseptic technique

Cell culture

Communication skills

Computer literacy

Education

High School diploma or equivalent

Tools

Microsoft Word

Microsoft Outlook

Equipment interfaces

Job description

Job 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.

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

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

Contract Length:

12 months with the chance to extend

Pay Range

$48-52/hr

Shift/Hours

The schedule for this role is Tuesday-Saturday

First Shift (7AM-3:30PM)

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals("Vertex"). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements