Manager, Manufacturing Operations

MFS Investments; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Commuting subsidy

401(k)

Job summary

Vertex, a global biotechnology company, seeks a Manager of Manufacturing Operations to lead the Drug Product Facility team and manage daily GMP-compliant manufacturing activities. The role requires coordinating with site leadership, overseeing staff performance, and driving improvements across processes and documentation.

The position emphasizes cGMP adherence, QbD, DoE, and SPC analytics, with a focus on safety, productivity, and collaboration across departments to deliver high-quality

Qualifications

• Bachelor's degree in a scientific/engineering discipline.
• 4+ years of experience or equivalent.
• Supervisory experience with direct reports.
• Experience in technology transfer, scale-up and late-phase development.
• Process development in solid oral dosage forms.
• Experience with cleaning validation.

Responsibilities

• Oversee day-to-day operations of the Drug Product Facility.
• Direct staff and prioritize tasks.
• Align with site leadership for departmental goals.
• Lead cross-departmental projects and improvements.
• Review and approve batch documentation.
• Conduct investigations, CAPA and change controls.

Skills

Leadership

Communication

cGMP knowledge

DOE

SPC

Data analysis

Education

Bachelor's degree in science/engineering

Tools

Quality by Design (QbD)

DOE

SPC

Job description

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 base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

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.