Senior Manager, Process Engineering

Vertex Inc.; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Paid time off

Educational assistance

Commuting subsidy

401(k) plan

Equity awards

Job summary

Vertex Inc. is seeking a Senior Manager, Process Engineering to lead manufacturing process activities across the Leiden Center and support CPI/DSDP compliance. You will provide technical and strategic guidance, coach a team, and drive process improvements from early to late-stage development.

The role requires advanced GMP/CMC knowledge, strong cross-functional collaboration, and experience with technology transfers and process validation to enable scalable, compliant outcomes for patients.

Qualifications

• PhD with 2+ years of experience, or MS with 5+ years, or BS with 8+ years.

Responsibilities

• Provide technical, strategic, and operational leadership across complex manufacturing activities.
• Represent Process Engineering on cross-functional teams, influencing late and early-stage development decisions.
• Develop and execute manufacturing strategies for technology transfers and process validations.
• Lead and develop staff, manage budgets, and ensure compliance and quality.
• Collaborate with CPI, DSDP, and Leiden Center stakeholders to align with quality and regulatory requirements.
• Establish relationships with suppliers and monitor process performance using SPC methods.

Skills

GMPs knowledge

CMC regulatory awareness

Project management

Technology transfer

Process validation

Statistical analysis

QbD knowledge

Cross-functional collaboration

Education

Bachelor’s degree in a relevant field

Master’s degree

PhD

Job description

Job Description

General Summary:

The Senior Manager, Process Engineering reports to the Senior Director of Manufacturing. The role is an emerging leadership position within the organization, providing technical, strategic, and operational leadership across complex manufacturing activities. This individual represents the Process Engineering function in cross-functional settings and helping to advance late and early - stage process and product development while reducing commercialization risk. The Senior Manager builds productive stakeholder relationships, translates departmental priorities into actionable plans, and leads a team of employees in delivering high-quality, compliant, and scalable outcomes. The position also supports the technical and compliance needs of CPI and DSDP, partnering closely with relevant stakeholders to ensure manufacturing activities are aligned with applicable quality, regulatory, and business requirements. This position reports to the Senior Director of Manufacturing and supports operations at the Leiden Center. The Senior Manager serves as a key Process Engineering partner for CPI and DSDP, ensuring their technical and compliance needs are addressed through effective planning, issue resolution, documentation, and cross-functional collaboration.

Key Duties and Responsibilities:

• Serve as a technical resource in one or more process engineering areas, adapting departmental plans and priorities to meet short-term operational objectives.
• Contribute to the development and implementation of departmental tools, standards, and best practices that support consistent execution and continuous improvement.
• Represent Process Engineering on cross-functional CMC teams, influencing late and early -stage process and product development decisions.
• Develop and execute manufacturing strategies for technology transfers and process validations, including strategic master plans, protocols, and technical reports.
• Establish and maintain effective working relationships with key suppliers of materials, technologies, and manufacturing resources.
• Evaluate process performance through statistical process control methods; identify, prioritize, and lead continuous improvement initiatives across the product lifecycle.
• Resolve complex manufacturing issues by applying new perspectives to existing solutions and support timely, scientifically sound resolution of quality investigations.
• Support CPI and DSDP technical and compliance needs at the Leiden Center, ensuring process engineering activities, documentation, and decisions meet applicable quality and regulatory expectations.
• Lead and develop assigned staff; as a people manager, assume appropriate financial accountability and human resource responsibilities.

Knowledge and Skills:

• Advanced knowledge of GMPs and associated CMC regulatory considerations in a pharmaceutical environment.
• Demonstrated experience managing projects within the pharmaceutical industry.
• Strong understanding and practical application of technology transfer and validation processes.
• Strong communication, collaboration, and team-building skills, with the ability to connect effectively at all organizational levels.
• Ability to manage multiple high-priority projects concurrently and influence stakeholders in a strong-matrix environment.
• Mastery of complex data analysis, mathematical modeling,
• Working knowledge of Quality by Design (QbD) principles and design of experiments methodology and implementation.

Education and Experience:

• Bachelor’s degree in relevant field
• PhD and 2+ years, or Master’s and 5+ years, or Bachelor’s and 8+ years.

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:

$140,000 - $210,000

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.

#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 [e-mail]