Senior Manager, Process Engineering

Vertex Inc.•Boston, MA

22h•$140,000 - $210,000•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends.
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.

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.