Senior CMC Operations Specialist, Technical Operations

reputed company is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine reputed company of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23.

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 reputed company 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 reputed company 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 reputed company 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.

reputed company 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 reputed company 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 reputed company 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 reputed company knowledge, experience, education, and geographic location.

As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national reputed company, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-reputed company characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and reputed company Spyre that is focused on developing life-changing products for patients.

reputed company, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates reputed company our industry. Please be aware that official recruiters at reputed company only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to reputed company any purchases or divulge sensitive personal information reputed company email.

Please also be aware that reputed company job postings will be listed on our website at spyre.com/careers/.