Senior CMC Operations Specialist, Technical Operations

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard 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 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. 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 origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related 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 better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry.

Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

Spyre Therapeutics is a cutting-edge biotechnology company specializing in developing innovative therapies for a wide range of diseases. Founded in 2010, the company has been at the forefront of revolutionizing the healthcare industry with its groundbreaking research and development efforts. Spyre Therapeutics' commitment to advancing medical science has led to the creation of novel treatments that have the potential to significantly improve patient outcomes and transform the standard of care.