Job Description
General Summary:
The Supervisor, Manufacturing Operations leads shift work in the cell therapy clinical manufacturing facility, assigning work according to detailed schedules and plans. Responsible for daily cGMP operations in the Vertex Drug Product Facility, including the set-up, assembly, operation, disassembly, and cleaning of process equipment, and overseeing the daily work of shift personnel.
Responsible for daily operations and staff allocations for first shift personnel.
Key Duties and Responsibilities:
Interface with relevant cross functional groups necessary for the operation and maintenance of the facility and manufacturing of drug product.
Execute and witness batch record instructions during cGMP operations.
Maintain facility in an audit ready state.
Supervise manufacturing personnel
Monitor GMP compliance in all cGMP activities with co-workers and anyone working within the Drug Product facility.
Maintain compliance with all on-going training requirements.
Follow SOPs, policies and all other relevant work instructions to ensure the successful and compliance operation of the drug product facility.
Knowledge and Skills:
A solid understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment.
Ability to follow verbal and written instructions in English.
Visual Acuity.
Ability to distinguish between the colors red, yellow, blue and green.
Ability to lift up to 50lbs.
Strong organizational skills.
Strong communication skills, as well as excellent documentation skills.
Basic computer skills and demonstrated ability to learn new systems and understand new technologies.
Occasional availability to work on other shifts may be necessary for onboarding and training.
Experience:
Typically requires 3 years of relevant work experience or the equivalent combination of education and experience
Supervisory experience
Experience with manufacturing systems utilizing computerized control systems and HMIs
Experience with continuous manufacturing and with manufacturing processes relevant to cell and gene therapy
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.
