Contract Program Manager-CMC & Manufacturing

Responsibilities

• Cook up cross-functional CMC and manufacturing activities to support NDA submission and launch
• Draw up and maintain timelines for device development, process development, and manufacturing readiness
• Host cross-functional team meetings, working sessions, and quality governance forums, crafting agendas and meeting minutes
• Track action items, risks, and dependencies tied to late-stage development activities
• Provide visibility into CMC activity statuses and spot potential risks
• Support integrated program planning and CMC submission readiness activities as necessary

Qualifications

• Requires a bachelor’s degree in a scientific, engineering, or technical field
• At least 3 years of relevant experience in CMC, technical operations, or manufacturing within the biotech/pharmaceutical industry
• Must have strong project management and cross-functional coordination skills with excellent communication abilities
• Experience managing integrated timelines and action tracking using Smartsheet or similar program management tools is essential
• Experience supporting manufacturing readiness activities such as process validation, tech transfer, or CMC submission deliverables is preferred
• PMP certification is preferred

Location/Travel Requirements

• Hybrid work model with onsite participation 2+ days per week
• Occasional travel to Massachusetts-based manufacturing sites may be required

Pay

The target salary range for this position is $60,000 - $60,000 USD.