Supervisor, Manufacturing Operations

Job Description

General Summary:

The Supervisor, Manufacturing Operations leads shift work in the clinical manufacturing facility, assigning work according to detailed schedules and plans. Responsible for daily cGMP operations in the clinical manufacturing area and overseeing the daily work of shift personnel. Responsible for daily operation and staff allocations for shift personnel. Ensures schedule adherence is met daily, troubleshoots, and escalates operational anomalies.

The work schedule for this Supervisor will be Sunday - Thursday, 1st Shift (7:30 am - 4 pm).

Key Duties and Responsibilities:

• Builds and develops an efficient team of 2-8 direct reports capable of consistently producing clinical product according to cGMP standards. Includes hiring, orienting, training and coaching of personnel

• Ensure 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

• 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:

• Ability to follow verbal and written instructions in English.

• Ability to lift up to 50lbs.

• Strong organizational skills.

• Strong communication skills, as well as excellent documentation skills.

• A solid understanding of the cGMP framework in the context of both development and commercial pharmaceutical drug product manufacturing environment.

• Basic computer skills and demonstrated ability to learn new systems and understand new technologies.

• Managing team development goals

Education and Experience:

• Prior GMP leadership experience, such as project or personnel leadership

• At least 5 years working in process development and / or manufacturing of cell therapy products preferred.

• Experience with embryonic or induced pluripotent stem cell culture

• Prior experience with scale-up processes

• Previous experience with electronic quality systems

• Experience collaborating with key stakeholders such as Quality Assurance and Supply Chain

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