Manufacturing Operations Senior Specialist

Job Description

The Manufacturing Operations Senior 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.

Additionally, the Manufacturing Operations Senior Specialist performs a variety of support functions as determined by management and the needs of the department.

The incumbent will have extreme attention to detail, technical writing skills, and commitment to patients.

The Senior Specialist will work one of the following shifts :

Sunday - Wednesday, 1st shift (7 : 00 am - 5 : 30 pm)

Below covers everything you need to know about what this opportunity entails, as well as what is expected from applicants.

Sunday - Wednesday, 2nd shift (12 : 30 pm - 11 : 00 pm)

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.
• Facilitate improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented.
• Participate in and facilitate technology transfer and final process development from the Research to the Manufacturing group.

Assist in the development of Standard Operating Procedures (SOPs) for manufacturing in collaboration with Research and Quality Systems groups.

• Contribute to technical projects both hands-on and documentation.
• Perform as a subject matter expert (SME) in some aspects of the role.
• Ensure raw materials are identified and available in time for manufacturing activities.
• Support Operations group to ensure proper coordination of resources.
• Ensure 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 as required to meet departmental requirements.

Knowledge and Skills :

• Ability to follow verbal and written instructions.
• Ability to generate clear written documentation, including strong technical writing.
• Minimum 2 years of experience in a GMP environment.
• Minimum 2 years of experience with cell culture and demonstration of aseptic technique.
• Minimum 3 years working experience in a relevant field (may be reduced based on education level).
• Intermediate computer skills, including Word, Excel, Outlook, equipment interfaces, and electronic quality systems.
• Experience with quality systems.

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 gases and LN2 are used in this process.

Flex Designation : On-Site Designated

On-Site Designated

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 [email protected].

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