Senior Manager, Manufacturing Operations (3rd Shift)

Vertex Pharmaceuticals Inc (US)

United States

On-site

USD 139,000 - 209,000

Full time

2 days ago
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Benefits offered by this job

Annual bonus
Equity awards
Comprehensive benefits
Paid time off

Job summary

Vertex Pharmaceuticals Inc. is seeking a Senior Manager, Manufacturing Operations to lead a supervisory team and oversee day-to-day cGMP manufacturing activities. You will drive safe, compliant production aligned with schedules and site goals, while maintaining audit-ready facilities and promoting continuous improvement.

Responsibilities include leading project efforts, managing batch documentation, and supporting validation and change control processes within a cross-functional environment.

Qualifications

  • Bachelor's degree in scientific/engineering field.
  • 10+ years of experience in cGMP manufacturing with supervisory responsibility.
  • Strong leadership and ability to drive cross-functional teams.

Responsibilities

  • Lead and develop a supervisory team for manufacturing operations.
  • Ensure alignment with production schedules and site objectives.
  • Oversee cGMP activities including equipment, documentation, and batch records.
  • Participate in investigations, CAPAs, and change controls.
  • Support validation activities, facility readiness, and compliance.
  • Maintain audit-ready facility and drive continuous improvement.

Skills

Leadership
cGMP knowledge
Cell therapy
CAPA
SPC data
Cross-functional

Education

Bachelor's degree

Tools

QDoCCS
GMP systems
POMS MES

Job description

Job Description General Summary:

The Senior Manager, Manufacturing Operations manages a supervisory team and provides oversight to the day-to-day operations. This position provides strategic and operational leadership to ensure safe, compliant, and efficient execution of cGMP manufacturing operations in alignment with production schedules, site objectives, and business priorities. The Senior Manager is accountable for maintaining an audit-ready facility, driving continuous improvement, building organizational capability, and supporting the successful production of pharmaceutical drug products.

Key Duties and Responsibilities:

Manage and develop a supervisory team, ensuring strong execution, accountability, and team effectiveness. Direct the activities of the group through management of staff, prioritization, and assignment of tasks. Responsible for aligning with site leadership to provide departmental and technical leadership. Assume a project leader role for departmental and interdisciplinary projects. Ensure work is prioritized, staffed, and executed in alignment with detailed production schedules and business needs. Oversee cGMP manufacturing activities, including equipment setup, assembly, operation, disassembly, cleaning, and associated support activities. Ensure compliant execution, review, and approval of batch documentation and other GMP records. Provide oversight for real-time on-the-floor batch record review and escalation of operational or compliance issues as needed. Participate in event investigations, CAPAs, and change controls in support of production and departmental objectives. Identify and continuously improve practices, procedures, and activities related to the department and site. Partner cross-functionally to support validation activities, facility readiness, investigations, and manufacturing objectives. Ensure the facility remains in an audit-ready state through adherence to procedures, documentation standards, and inspection readiness practices. Monitor and enforce GMP compliance for personnel, processes, and activities. Drive operational performance through tiered management systems, including leadership of Tier 1 and/or Tier 2 meetings and follow-up on escalated issues. Monitor manufacturing performance metrics and trends; identify risks and drive actions 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. Foster interdisciplinary communication, collaboration, and shared understanding within the group and across departments. Ensure personal and team compliance with all training requirements. 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:

Advanced interpersonal, communication, and organizational skills. Strong leadership and people management skills, with the ability to lead through others and build high-performing teams. Demonstrated ability to mentor and develop supervisors and emerging leaders. Strong organizational, planning, and operational management skills, with the ability to manage competing priorities across multiple activities. Deep knowledge of cGMP principles and associated regulatory expectations in a pharmaceutical manufacturing environment. Strong understanding of cell therapy manufacturing operations, including process execution, equipment operation, and facility support requirements. Demonstrated competency in process, equipment, and facility validation experience. Experience with event investigations, deviation management, CAPA, change control, and inspection readiness. Proficiency with Quality by Design (QbD) concepts, Design of Experiments (DoE), statistical process control (SPC), and complex data analysis. Strong problem-solving and decision-making skills, with the ability to assess operational risk, escalated appropriately, and drive resolution. Ability to improve systems, processes, and team performance through continuous improvement principles. Ability to clearly communicate technical and operational rationale for procedures, practices, and manufacturing approaches. Proficiency with manufacturing systems and documentation platforms, including QDoCCS and other GMP systems.

Education and Experience:

Bachelor’s degree required in a scientific, technical, or engineering discipline. Typically requires 10+ years of experience or the equivalent combination of education and experience. Strong experience in direct people supervision in a cGMP manufacturing environment required. Significant leadership experience in pharmaceutical manufacturing operations within a cGMP-regulated environment required. Prior experience managing supervisors and/or manufacturing teams. Prior cell therapy and aseptic manufacturing experience. Prior POMS MES experience preferred. Experience supporting commercial and/or late-stage development manufacturing preferred.

Work Schedule

This position supports our overnight operations. Availability to work other shifts may be necessary to support onboarding, training, and critical manufacturing activities. 3rd 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 overnight schedule. 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: Sun - Thurs OR Tues- Saturday 7am - 3:30pm. OR Tuesday - Saturday 2:30pm -11pm The ongoing work shift thereafter will be 4x10hr shifts: Sunday - Wed 9pm -7:30am OR Wed - Saturday 9pm - 7:30am 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:

$139,100 - $208,700

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 the 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.

#LI-Onsite

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. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.

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