Senior Chemistry, Manufacturing, and Controls Operations Specialist - Technical Operations

Title: Senior CMC Operations Specialist, Technical Operations

Location: US- Remote

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.