Associate/Sr. Associate - CMC Project Management & Operations
$104,000–$125,000 year
HybridWaltham, Massachusetts, United States
Job Summary
Support CMC program execution by coordinating late-stage manufacturing, process development, analytical, quality, and regulatory readiness activities. Manage documentation workflows, including drafting support, version control, review routing, and archival of key program documents. Maintain integrated trackers for deliverables such as batch records, protocols, and stability updates. Prepare meeting materials, action-item trackers, and follow-up communications for CMC team meetings. Track risks, issues, and dependencies across workstreams, escalating delays or misalignments to the CMC Program Manager. Coordinate with external partners and CDMOs by managing document exchanges and deliverable status updates. Contribute to continuous improvement of project management tools and processes. Work from the Waltham office three days per week.
Required Qualifications
- Master's degree in life sciences, engineering, pharmaceutical sciences, biotechnology or a related discipline with 0-2 years relevant experience
- Bachelor's degree with 2-4 years of relevant experience
- Experience in a biopharmaceutical, biotechnology, or regulated drug development environment
Desired Qualifications
- Some experience in drug development, manufacturing, CMC, or a related scientific field
- Experience in manufacturing, drug development, process development, analytical or other CMC-related functions
- 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
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