CMC Project Management

CMC Project Manager (Manager/Sr. Manager)

Location: Hybrid/Remote Biologics | Inflammation | Immunology

Years of Experience: 5–10 Industry experience, with a minimum of 3 years in CMC project managementBelenos Biosciences is a clinical-stage biotech developing innovative biologics for chronic inflammatory diseases, including asthma, COPD, atopic dermatitis, and other immunologic conditions. With multiple bispecific programs advancing into clinical development, we are building a world-class team to bring transformative medicines to patients globally. We value scientific excellence, operational rigor, out-of-the-box thinking and have a culture built on accountability, collaboration, and joy. 

Position Summary 

We are seeking a highly organized and proactive CMC Project Manager (Manager or Senior Manager level) to support CMC activities across at least two active development programs. This individual will oversee day-to-day project operations, drive CMC timelines, coordinate cross-functional inputs, and serve as a key communication bridge between Belenos Biosciences and external manufacturing and testing partners. 

The ideal candidate has 3+ years of CMC operational and project management experience in biotech or pharma and excels at managing multiple vendors, integrating complex timelines, and identifying risks early. This role reports to the Head of Program Management. 

Key ResponsibilitiesProject & Vendor Management 

·      Lead daily operational project management across multiple CMC programs. 

·      Maintain, track, and update integrated CMC project timelines across all vendors (DS, DP, labeling). 

·      Coordinate and attend recurring meetings with external vendors, ensuring clear agendas, action items, and timely follow-up. 

·      Manage coordination of shipments, sample transfers, and logistics between Belenos and external partners. 

Communication & Cross-Functional Alignment 

·      Provide routine status updates, risk assessments, and mitigation strategies to the internal team. 

·      Work closely with the Head of Manufacturing, assisting with execution and team alignment. 

·      Escalate issues proactively to the Head of Manufacturing and recommend operational solutions. 

Execution & Documentation 

·      Help ensure deliverables from external partners meet program needs, including batch records, testing reports, protocols, and manufacturing schedules. 

·      Support the Head of Manufacturing in operational planning, scenario planning, and preparation of timelines for internal and external meetings. 

·      Track key risks, dependencies, and milestones to maintain project momentum. 

Qualifications 

·      5–10 years of industry experience, with several years in CMC, technical operations and project management within the biotech or pharmaceutical industry. 

·      Small biotech or start-up experience highly preferred (but not required). 

·      Demonstrated success managing CDMOs and other external vendors preferred. 

·      Strong understanding of end-to-end CMC development processes for biologics (drug substance, drug product, analytical, supply chain). 

·      Proven ability to integrate complex timelines and manage critical project paths. 

·      Excellent communication, organizational, and interpersonal skills. 

·      Ability to work independently in a remote environment while maintaining strong team alignment. 

·      PMP certification a plus but not required. 

Why Join Us 

·      Fully remote position with flexibility and autonomy. 

·      Opportunity to shape CMC operations in a high-growth biotech. 

·      Collaborative, supportive, and mission-driven team. 

·      Impactful work directly tied to advancing clinical programs. 

CONTACT: Please send cover letter and CV to Mark Carlson, mcarlson@belenosbio.com