Job Description

General Summary:

The Manager, Manufacturing Operations manages a team and gives oversight to the day-to-day operations of the Drug Product Facility. The responsibilitiesinclude defining and directing activities for the DPF and DPF personnel while maintaining organizationalbalance across the group. The Manager will foster interdisciplinary communicationand understanding within the group and with other departments.

Key Duties and Responsibilities:

• Responsible for day-to day operation of the Drug Product Facility and maintaining a cGMP environment
• Direct the activities of the group through managing of staff, prioritization and assignment of tasks
• Responsible for aligning with site leadership to provide departmental and technical leadership
• Assist in departmental and interdisciplinary projects
• Facilitate improvements to documentation, procedures, and processes that will enhance efficiency and ensure best practices are implemented
• Author or review and approve batch documentation
• Perform event investigations, CAPA and change controls in support of production and the department
• Collaborate with other departments, both internal and external to coordinate maintenance down periods and equipment upgrades
• Identify and continuously work to improve practices, procedures and activities as related to the department and site
• Enable the timely achievement of departmental, site, and corporate goals
• Mentor, motivate, and evaluate the performance of group members
• Author and submit revisions to controlled documents in QDoCCS in support of GMP Operations.

Knowledge and Skills:

• Strong interpersonal, communication and organizational skills
• Demonstrates competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment, including process, equipment, and facility validation experience
• Proficiency with Quality by Design (QbD) concepts, DoE, statistical process control (SPC) and complex data analysis

Education and Experience:

• Bachelor's degree with preference in a scientific, technical or engineering discipline
• 4+ years experience or the equivalent combination of education and experience
• Supervisory experience with direct oversight and management of direct reports, assigning duties, job functions, selecting, training and giving feedback.
• Experience in technology transfer, scale-up, and late phase clinical development
• Process Development experience in solid oral dosage forms and a sound understanding of the pharmaceutical development process
• Experience with cleaning validation

Work Schedule

This position supports our 1st shift operations. Availability to work other shifts may be necessary to support onboarding, training, and critical manufacturing activities.

1st Shift: Training Period

New hires will complete an onboarding and training program on their assigned shift schedule to ensure successful integration into the role.

Training will take place between our Cambridge Facility: 100 Tech Drive and Leiden Center 1 (LC1) in Seaport.

The training period will run through January / February 2027, with 5x8hr shifts: Tuesday - Saturday 7am - 3:30pm

The ongoing work shift thereafter will be 4x10hr shifts: Wednesday - Saturday 5am - 3:30pm

At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.

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 Vertexs Policy on Flex @ Vertex Program and may be changed at any time.

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