About this role

Job Description

General Summary:

The Manager, Manufacturing Operations leads cell therapy manufacturing activities and ensures execution aligns with production schedules, operational plans, and business objectives.

This role is responsible for defining and directing activities for cell therapy and cell therapy personnel while maintaining organizational balance across the group.

This position is accountable for safe, compliant, and efficient cGMP operations, including equipment setup, assembly, operation, disassembly, and cleaning, while providing leadership to supervisors and manufacturing staff. The Manager will foster interdisciplinary communication and understanding within the group and across departments, maintain an audit-ready facility, and support the successful production of pharmaceutical drug products.

Key Duties and Responsibilities:

- Lead and manage daily manufacturing operations.
- Provide leadership, direction, and support to Manufacturing Supervisors and frontline manufacturing personnel.
- Direct the activities of the group through management of staff, prioritization, and assignment of tasks.
- Ensure work is assigned and executed in alignment with detailed production schedules, operational priorities, and business needs.
- Responsible for aligning with site leadership to provide departmental and technical leadership.
- Oversee cGMP manufacturing activities, including equipment setup, assembly, operation, disassembly, and cleaning.
- Ensure accurate execution, authoring, review, and approval of batch documentation to maintain compliant manufacturing records.
- Execute and oversee real-time on-the-floor batch record review and escalation of issues as needed.
- Author or review and approve batch documentation.
- Partner with cross-functional teams to support facility operations, maintenance activities, investigations, deviations, change controls, and manufacturing objectives.
- Monitor and enforce GMP compliance for all personnel, processes, and activities.
- Maintain the facility in an audit-ready state through adherence to procedures, documentation practices, and inspection readiness standards.
- Ensure compliance with SOPs, policies, and work instructions to support safe and successful facility operation.
- Identify and continuously improve practices, procedures, and activities related to the department and site.
- Drive operational performance through structured tiered management, including leading Tier 1 meetings and supporting Tier 2 escalation and follow-up as needed.
- Monitor manufacturing performance metrics and identify opportunities to improve safety, quality, delivery, and cost.
- Enable the timely achievement of departmental, site, and corporate goals.
- Mentor, motivate, coach, and evaluate the performance of group members.
- Lead, coach, and develop supervisors and team members to build organizational capability and support succession planning.
- Ensure personal and team compliance with all training requirements.
- Foster interdisciplinary communication and understanding within the group and with other departments.
- Demonstrate the Vertex Phenotype behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.
- Perform other duties and projects as assigned to meet departmental and business requirements.

Knowledge and Skills:

- Strong interpersonal, communication, and organizational skills.
- Demonstrated leadership skills, including the ability to lead through others, develop teams, and drive accountability and performance.
- Strong capability to mentor, motivate, coach, and develop direct reports and emerging leaders.
- Effective interpersonal, verbal, and written communication skills, with the ability to work across functions in a dynamic team environment.
- Strong organizational and operational management skills, with the ability to manage competing priorities and maintain timelines across multiple activities.
- Sound understanding of relevant drug development and manufacturing activities, including applicable standard operating procedures (SOPs).
- Strong problem-solving and decision-making skills, with the ability to assess issues, escalate appropriately, and drive resolution.
- Ability to clearly communicate rationale for procedures, practices, and technical approaches.
- Demonstrated competency in the principles and practice of cGMPs and associated regulatory considerations in a pharmaceutical environment.
- Solid understanding of process, equipment, and facility validation requirements.
- Solid understanding of the cGMP framework in both development and commercial pharmaceutical drug product manufacturing environments.
- Working knowledge of inspection readiness, deviation management, CAPA, change control, and continuous improvement practices.
- Proficiency with Quality by Design (QbD) concepts, Design of Experiments (DoE), statistical process control (SPC), and complex data analysis.
- Ability to use manufacturing systems and documentation tools, including QDoCCS and other GMP systems, in support of compliant operations.

Education and Experience:

- Bachelor’s degree required, preferably in a scientific, technical, or engineering discipline.
- 4+ years of experience or the equivalent combination of education and experience.
- Prior people leadership experience required, including experience managing staff, supervisors, and/or manufacturing teams.
- Prior cell therapy and aseptic manufacturing experience preferred.
- Prior POMS MES experience preferred.
- Experience in pharmaceutical manufacturing operations within a cGMP-regulated environment required.

Work Schedule

This position supports our 2nd shift operations. Availability to work other shifts may be necessary to support onboarding, training, and critical manufacturing activities.

2nd Shift Training Period:

New hires will complete an approximately 90-day training program on either first shift or second shift before transitioning to the assigned regular shift.

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 2:30pm - 11pm.

The ongoing work shift thereafter will be 4x10hr shifts: Wednesday - Saturday 1pm - 11:30pm

2nd shift employees are entitled to 10% pay differential

Please note that work schedules are based on business needs and may be adjusted or modified as operational requirements evolve. Candidates must be flexible and able to accommodate schedule changes, including shifts, assigned days or hours, as determined by Vertex.

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.

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