Manufacturing Operations Senior Associate (Contract)

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

$48-52/hr

The schedule for this role is Tuesday-Saturday

First Shift (7AM – 3:30PM)

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

By applying for this position, you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials, which may include your CV/Resume, email address or phone number, with Vertex. For more information on how Vertex handles your personal data related to your job application, please see Vertex’s Careers Privacy Notice.   Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners

(collectively, “Atrium Alerts”). Atrium Alerts may be sent by email, phone, or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time, please contact Atrium at

privacyadministrator@atriumstaff.com

If you do not agree with the Atrium Terms and Conditions, you can still complete your application for this position by emailing your resume to our team at

tempstaffing@vrtx.com

No C2C or Third-Party Vendors