Vertex Pharmaceuticals Incorporated
Supervisor, Manufacturing Operations
Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298
Job DescriptionThe Manufacturing Operations Supervisor is a critical first-line leadership role within Cell Manufacturing. This position is responsible for direct management of personnel executing GMP cell processing operations for adherent and suspension cell cultures. The incumbent will have strong leadership skills, GMP expertise, and commitment to patients.The Supervisor will work
one of the following shifts :
Sunday - Wednesday, 1st shift (7:00 am - 5:30 pm)Sunday - Wednesday, 2nd shift (12:30 pm - 11:00 pm)
Wednesday - Saturday, 1st shift (7:00 am - 5:30 pm)Wednesday - Saturday, 2nd shift (12:30 pm - 11:00 pm)Key Duties and Responsibilities:Builds and develops an efficient team of 2-8 direct reports capable of consistently producing clinical cellular product or intermediates according to cGMP standards. Includes hiring, orienting, training and coaching of personnel.Ensures cGMP compliance through direct oversight and education of team members.Shares responsibility of scheduling of personnel in coordination with other Manufacturing leadership.Manages direct reports' projects to achieve department and corporate goals, including managing timelines and leading group meetings.Leads, investigates, and collaborates with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments.Creates, revises, and reviews controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing.Receives and manages equipment alarms.Serves as a technical SME for the team, troubleshoots problems independently.Demonstrates 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:Extensive GMP experience, including as a lead or trainer.Minimum of 3 years of cell culture experience, ideally in both adherent and suspension cultures.A minimum of 0-2 years direct supervisory experience.Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820).Expertise in cell processing and culture technologies for clinical materials production required.Experience with bioreactors for cell culture.Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems.Environment:Works in a cleanroom and office setting.Must be able to remain in a stationary position 50% during processing activities.Frequently moves 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.Flex Designation:
On-Site DesignatedFlex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.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.
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one of the following shifts :
Sunday - Wednesday, 1st shift (7:00 am - 5:30 pm)Sunday - Wednesday, 2nd shift (12:30 pm - 11:00 pm)
Wednesday - Saturday, 1st shift (7:00 am - 5:30 pm)Wednesday - Saturday, 2nd shift (12:30 pm - 11:00 pm)Key Duties and Responsibilities:Builds and develops an efficient team of 2-8 direct reports capable of consistently producing clinical cellular product or intermediates according to cGMP standards. Includes hiring, orienting, training and coaching of personnel.Ensures cGMP compliance through direct oversight and education of team members.Shares responsibility of scheduling of personnel in coordination with other Manufacturing leadership.Manages direct reports' projects to achieve department and corporate goals, including managing timelines and leading group meetings.Leads, investigates, and collaborates with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments.Creates, revises, and reviews controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing.Receives and manages equipment alarms.Serves as a technical SME for the team, troubleshoots problems independently.Demonstrates 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:Extensive GMP experience, including as a lead or trainer.Minimum of 3 years of cell culture experience, ideally in both adherent and suspension cultures.A minimum of 0-2 years direct supervisory experience.Working knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820).Expertise in cell processing and culture technologies for clinical materials production required.Experience with bioreactors for cell culture.Excellent computer skills including Word, Excel, Project, Outlook, equipment interfaces and electronic quality systems.Environment:Works in a cleanroom and office setting.Must be able to remain in a stationary position 50% during processing activities.Frequently moves 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.Flex Designation:
On-Site DesignatedFlex Eligibility Status:
In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.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.
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