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Manufacturing Operations Senior Scientific Associate

Semma Therapeutics

Semma Therapeutics

Operations
Multiple locations
Posted on Tuesday, November 7, 2023

Job Description

Job Description

The Manufacturing Operations Senior Associate 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.

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

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.

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.