Companies you'll love to work for

Supervisor, Manufacturing Operations

Semma Therapeutics

Semma Therapeutics

People & HR, Operations
Boston, MA, USA
Posted on Tuesday, June 25, 2024

Job Description

The 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.

  • Receive and manage 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 assign 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 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

Flex Designation:

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 ApplicationAssistance@vrtx.com