Associate/Sr. Associate - CMC Project Management & Operations

Key Responsibilities

• Support CMC program execution by assisting the CMC Program Manager with day-to-day coordination of late-stage manufacturing, process development, analytical, quality, and regulatory readiness activities.
• Manage CMC documentation workflows, including drafting support, formatting, version control, review routing, comment resolution tracking, approvals, and archival of key program documents.
• Maintain integrated CMC trackers and timelines for deliverables such as batch records, protocols, reports, specifications, comparability documentation, stability updates, regulatory content, and manufacturing readiness milestones.
• Prepare meeting materials and outputs, including agendas, decision logs, action-item trackers, meeting minutes, dashboards, and follow-up communications for CMC team meetings and governance reviews.
• Track risks, issues, decisions, and dependencies across CMC workstreams and escalate delays, gaps, or cross-functional misalignments to the CMC Program Manager.
• Support external partner and CDMO coordination by managing document exchanges, action trackers, meeting follow-ups, deliverable status updates, and communication records.
• Contribute to continuous improvement of CMC project management tools and processes, including templates, trackers, document control practices, reporting formats, and readiness checklists.

Qualifications

• Master’s degree in life sciences, engineering, pharmaceutical sciences, biotechnology or a related discipline with 0-2 years relevant experience, or Bachelor’s degree with 2-4 years of relevant experience.
• Experience in a biopharmaceutical, biotechnology, or regulated drug development environment is required.
• Experience in manufacturing, drug development, process development, analytical or other CMC-related functions is preferred.
• Strong organizational skills with the ability to manage multiple priorities, track deliverables, maintain timelines, and follow up on action items.
• Excellent written and oral communication skills, with the ability to prepare clear meeting summaries, trackers and cross-functional messages.
• Ability to work independently while knowing when to escalate risks, issues or delays.
• Proficiency with standard business and project-management tools, such as Microsoft Office, Sharepoint, Smartsheet or similar systems.
• Ability to operate in a fast-paced, timeline-driven environment and adapt to changing program priorities.
• Basic understanding of regulated documentation practices, GMP concepts or CMC development workflows is preferred.

What We Offer

• A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
• Opportunities for professional growth and development.

Location

Waltham, MA
Hybrid – onsite 3 days/week required

Salary Range for the Role

$104,000 - $146,000 USD