Senior CMC Operations Specialist, Technical Operations

Role Summary:

The  Senior CMC Operations Specialist supports execution across Technical Operations by coordinating cross-functional activities spanning DS/DP, AD/QC, Supply Chain, Device, Regulatory CMC, and Quality to enable on-time manufacturing and release. This role manages task intake, documentation workflows, and action item tracking, while ensuring GMP documentation is complete, accurate, and inspection-ready. It also coordinates vendor interactions, sample shipments, and inventory tracking to maintain operational continuity. Acting as a liaison between functions, this position helps ensure alignment, compliance, and efficient day-to-day execution in a fast-paced environment. The position reports to the Director, CMC Operations.

Key Responsibilities:

• Serve as central coordinator across TechOps functions, supporting execution of cross-functional projects and activities
• Manage vendor and internal task intake, including tracking, documentation routing, and approval coordination
• Coordinate sample shipments and maintain inventory tracking to ensure accuracy and availability
• Provide logistics support for Supply Chain, including shipments of clinical drug product and finished goods
• Ensure completeness, accuracy, and organization of GMP documentation, including remediation and structuring of legacy files
• Maintain and track action items across projects, ensuring timely follow-up and closure
• Act as liaison between TechOps and Quality, supporting alignment with quality systems and processes
• Other duties as assigned

Ideal Candidate:

• Bachelor’s degree in life sciences, engineering, or related field 
• Minimum 3 years in biotech/pharma operations or analytical/CMC functions.
• Experience working in GMP or other regulated environments.
• Demonstrates high accountability and personal responsibility.
• Strong project management and cross-functional coordination experience.
• Skilled in documentation management and vendor communication.
• Proficiency in Microsoft Office and SharePoint tools.
• Experience creating and maintaining dashboard tools
• Demonstrated initiative, organization, and attention to detail.
• Excellent written communication and follow-through in a remote, fast-paced setting.

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $135,000 to $155,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.