Description

JOB TITLE: Project Manager II, Technical Operations, CMC

REPORTS TO: Director Strategy, Planning and Operations

LOCATION: Boston MA DATE PREPARED: July 20, 2026

JOB SUMMARY:

The Technical Operations Project Manager II, CMC (PM II) serves as a primary day-to-day contact for the internal CMC project team and external contract manufacturing organizations (CMOs/CDMOs), testing laboratories, and other project business partners. This position is responsible for coordinating and tracking clinical and/or commercial manufacturing activities, maintaining regulatory expectations, meeting production timelines, supports vendor coordination, tech transfers, inter department communications and supporting appropriate business functions such as invoice management and budget reconciliation. This position is also responsible for maintaining CMC project schedules, tracking metrics, and assembling documentation for regulatory submissions. The PM II works closely with external partners and collaborates internally with Quality Assurance, Regulatory Affairs, Supply Chain, and Analytical Development teams.

PRINCIPAL DUTIES:
• Project Execution: Manage day-to-day CMC project activities to meet defined manufacturing timelines while ensuring adherence to cGMP guidelines and relevant SOPs.
• Vendor Coordination: Coordinates the management of CDMOs, CMOs, and analytical testing laboratories by tracking production schedules, action items, and deliverables.
• Timeline Tracking: Maintain and update detailed project plans, tech transfer trackers, Gantt charts, and supply chain schedules.
• Campaign Support: Track manufacturing campaign progress, and facilitate timely batch record reviews and deviation resolutions between internal teams and vendors.
• Tech Transfer Support: Assist with the coordination of tech transfer protocols, validation plans, and occasional site visits during production campaigns if required.
• Cross-Functional Coordination: Act as a central communication link between Technical Operations and internal departments (Quality, Regulatory, Supply Chain) to keep project timelines aligned.
• Status Reporting: Prepare regular project status reports, action item logs, and risk registers for Technical Operations leadership.

BASIC QUALIFICATIONS:
• Education: BS/BA degree or equivalent in Engineering, Chemistry, Life Sciences, or a related technical discipline.
• Experience: 3-5 years of biotech, pharma, or CDMO industry experience, with at least 3 years of hands-on project management experience within Technical Operations or CMC.
• Certification: PMP (Project Management Professional) certification is preferred.
• Technical Knowledge: Foundational understanding of drug substance (DS) or drug product (DP) manufacturing processes, tech transfer steps, or scale-up activities.
• Vendor Exposure: Experience working directly with or managing deliverables from external vendors, CMOs, or CDMOs.
• Regulations: Strong understanding of cGMP guidelines and familiarity with ICH requirements.
• Skills: Excellent organizational, time-management, and communication skills with high attention to detail. Proficiency with project management software (e.g., MS Project, SmartSheet, Excel, PowerPoint).
• Travel: Ability to travel 5-10% of the time for occasional site visits and manufacturing oversight.