Job Description

General Summary

Reporting to the Senior Director, Manufacturing Operations, this role is responsible for developing and executing the Technical Support strategy for technology transfer, product commercialization, and lifecycle management. The individual will also support key manufacturing systems and processes, including change controls, risk assessments, deviations, and GMP documentation.

This role leads and mentors the Technical Support team and provides oversight for technology transfer, process optimization, continuous improvement initiatives, and manufacturing process performance monitoring. The Senior Manager will collaborate cross-functionally with Process Development (PD), Analytical Development (AD), Quality Control (QC), Operational Quality, Materials Management, Operations, and other stakeholders to enable efficient process transfer and sustained manufacturing performance.

Key Duties and Responsibilities:

• Lead Technical Support initiatives, contribute to strategy development, and manage team resources to achieve Manufacturing Operations objectives.
• Oversee the sustained performance and continuous improvement of cell and gene therapy manufacturing processes.
• Lead a team of manufacturing engineers and specialists supporting the technology transfer and continuous improvement of equipment, processes, and control systems.
• Represent Technical Support and Operations at cross-functional daily management meetings, maintaining visibility to technical issues and action plans across the manufacturing floor.
• Serve as the primary escalation point for manufacturing issues; coordinate resolution with subject matter experts and communicate status to management.
• Drive structured, closed-loop problem solving to improve manufacturing performance, including uptime and yield; identify root causes and implement sustainable corrective actions.
• Establish and lead process performance monitoring and improvement strategies, including optimization, lifecycle management, and operational excellence. Use aligned KPIs to identify and close performance gaps.
• Partner with cross-functional stakeholders to promote phase-appropriate design for manufacturability and improve manufacturing performance.
• Own the development of internal master batch records, SOPs, work instructions, and related documentation required for technology transfer, in collaboration with Development and Quality.
• Support deviation management, CAPA, and change control activities, as needed. Serve as the process SME for Quality, Supply Chain, Manufacturing, and other functions. Support manufacturing investigations, including OOS, OOT, and root cause analyses.
• Ensure compliance with all regulatory, corporate, and Quality System requirements.

Knowledge and Skills:

• Demonstrated experience in process development, technology transfer, process optimization, technical operations, and lifecycle management.
• Strong technical problem-solving, technical writing, and presentation skills. Lean Six Sigma Green Belt or Black Belt preferred.
• Strong sense of urgency, with the ability to escalate issues promptly and communicate transparently with stakeholders and management.
• Ability to work independently with minimal supervision, manage multiple priorities, and support several projects simultaneously.
• Strong interpersonal, collaboration, and teamwork skills.

Education and Experience:

• BS or MS in Chemical Engineering or a related discipline.
• Minimum of 6 years of experience in cell and gene therapy manufacturing, biopharmaceutical manufacturing, or a related pharmaceutical environment.
• Minimum of 3 years of people management experience preferred.

Pay Range:

Disclosure Statement:

Flex Designation:

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.

#LI-Onsite

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