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 responsibilities include defining and directing activities for the DPF and DPF personnel while maintaining organizational balance across the group. The Manager will foster interdisciplinary communication and 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:
$119,900 - $179,900
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual…