CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Manufacturing Operations Senior Specialist

Company: Vertex Pharmaceuticals, Inc
Location: Cambridge
Posted on: September 21, 2022

Job Description:

Job Description

Cell Manufacturing Operations Senior Specialist

Job Description

The Manufacturing Operations Specialist is an on-site project lead role within Cell Manufacturing. This position is responsible for driving projects to completion within the GMP cell processing operations team. The incumbent will have expertise in cell culture and GMP as well as exceptional project management skills.

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, reporting deviations
* Provides experience-related information to drive more efficient technology transfer and final process development from the Development to the Manufacturing group. Assists in the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with Research and Quality Systems groups
* Ensures cGMP compliance through manufacturing oversight and tracking
* Monitors scheduling and assists with coordinating resources such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities
* Manage individual projects, including managing timelines and leading small group meetings
* Receive and manage equipment alarms
* Serves as the main technical SME for the team, troubleshoots problems independently
* 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 assign as required to meet departmental requirements

Knowledge and Skills:

* Minimum of 3 years cell culture experience, ideally in both adherent and suspension cultures
* Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems
* Extensive experience with technical writing
* Minimum 6 years working experience in relevant field (may be reduced based on education level)
* Extensive GMP experience, including as a lead or trainer
* Expertise in cell processing technologies for clinical production
* Experience with bioreactors for cell culture
* Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)

Environment:

* Works in a cleanroom and office setting
* Must be able to remain in a stationary position 50% during processing activities
* Frequently move about inside the cleanroom to accomplish process tasks
* Occasionally moves lab equipment and materials weighing up to 50 pounds.
* Compressed gasses and LN2 are used in this process

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.

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.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.

Keywords: Vertex Pharmaceuticals, Inc, Cambridge , Manufacturing Operations Senior Specialist, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds