SUMMARY

The Sr.  Process Engineer MS&T – LVV Manufacturing is a technical leader responsible for sustaining, improving, and scaling GMP processes for Lentiviral Vector (LVV) manufacturing. This role serves as a key process owner across the product lifecycle, providing hands-on technical support for commercial manufacturing, technology transfer and continuous improvement.

You will partner closely with Manufacturing, Quality, Process Development, Analytical Development, Supply Chain, and external partners to ensure processes are compliant, robust, and capable of meeting commercial demand.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

MS&T Leadership

• Lead or support MS&T activities including process characterization, validation, comparability, and continued process verification (CPV)
• Drive process robustness, yield improvement, and cost-of-goods reduction initiatives
• Provide technical leadership for process deviations, investigations, and root cause analysis

• Serve as process SME within MS&T for assigned unit operations and LVV manufacturing processes.
• Provide real-time technical support for GMP manufacturing operations, including investigation of deviations, root cause analysis, and implementation of corrective and preventive actions (CAPAs).

Cross-Functional Collaboration

• Act as a key technical interface with Quality, Regulatory Affairs, Analytical, and External Manufacturing partners
• Support regulatory filings, responses, and lifecycle submissions
• Support technology transfer activities between development and external CDMOs.
• Collaborate with Quality and Regulatory teams to support inspections, audits, and regulatory submissions
• Represent LVV manufacturing in governance forums and senior leadership discussions

Leadership & Collaboration

• Support the overall CMC and manufacturing strategy for LVV production
• Collaborate closely with a CDMO network for technical support for manufacturing activities
• Establish a strong culture of accountability, continuous improvement, and technical rigor

QUALIFICATIONS 

Education and Experience

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree
• 5+ years of experience in manufacturing, MS&T or CMC roles in the biopharma industry,
• Deep experience managing contract manufacturing and external supply networks in LVV manufacturing
• Strategic thinker with strong technical skills and a hands-on operational leader

Skills and Competencies

• Demonstrated ability to lead cross-functional teams, manage complex projects, and influence at all levels of the organization
• Deep knowledge of cGMP, GDP, and regulatory requirements (FDA, EMA, ICH)
• Exceptional leadership, communication, and cross-functional collaboration skills

The CMC Project Manager is responsible for driving cross‑functional execution of Commercial CMC programs for approved cell and gene therapy products. This role partners closely with CMC functional leaders and teams to ensure disciplined planning, risk management, and delivery of post‑approval commitments that support uninterrupted commercial supply.

A primary focus of the role will be leading a CMC sub‑team, including coordination with an external partners, to deliver a critical commercial milestones. This position operates in a highly matrixed environment and requires strong project leadership, clear communication, and the ability to manage complex interdependencies across CMC functions.

This role is a full time hybrid position (3 days a week in the office) located in our Somerville, Massachusetts office.

RESPONSIBILITIES

• Lead Commercial CMC teams and drive execution of CMC activities aligned with program, regulatory, and supply objectives
• Develop, maintain, and actively manage integrated CMC project plans, including timelines, dependencies, critical path activities, and decision points
• Establish and maintain a CMC risk registry; proactively identify risks, define mitigation strategies, and escalate issues to prevent program delays
• Lead cross‑functional coordination across Manufacturing, Quality, Analytical Development, Regulatory CMC, Supply Chain, and external partners to resolve complex CMC issues
• Manage CMC execution in collaboration with key external partners, ensuring accountability to scope, timeline, and deliverables for key commercial milestones
• Prepare and deliver concise, data‑driven updates to senior leadership and governance forums on CMC status, risks, and execution options
• Co‑lead CMC team meetings and governance forums, applying strong meeting management practices to enable timely decision‑making and follow‑through
• Promote a culture of ownership, accountability, and continuous improvement across CMC project teams

QUALIFICATIONS

• Bachelor’s, Master’s, or Ph.D. in life sciences or a related discipline, or equivalent industry experience
• Minimum of 6 years of biopharmaceutical industry experience; experience supporting late‑stage or commercial programs strongly preferred
• At least 2 years of project management experience or demonstrated success leading cross‑functional teams in a fast‑paced biotech or pharmaceutical environment
• Proven ability to manage complex, cross‑functional programs, identify and mitigate risk, and drive execution in a matrixed organization
• Strong working knowledge of CMC development, manufacturing, and quality concepts; cell and gene therapy experience is a strong plus
• Proficiency with project management and collaboration tools, including Microsoft Project, PowerPoint, Excel, and OneNote
• Strong organizational skills with the ability to manage multiple priorities and shifting timelines
• Demonstrated ability to translate complex technical plans into clear, actionable communication for technical and non‑technical stakeholders