Senior Manager, Tech Support

Vertex Inc.•Boston, MA

11d•$136,800 - $205,200•Onsite

About The Position

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.

Requirements

Demonstrated experience in process development, technology transfer, process optimization, technical operations, and lifecycle management.
Strong technical problem-solving, technical writing, and presentation skills.
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.
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.

Nice To Haves

Lean Six Sigma Green Belt or Black Belt preferred.

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.