Equilibrynt LLC Manager, CMC Project Management Remote · Contractor Company website

Apply for Manager, CMC Project Management

eQuilibrynt is a consulting firm that supports biopharma organizations in accelerating drug development by improving execution. The company focuses on aligning people, processes, and technology to clarify decision-making, strengthen governance, and keep complex programs on track.

Key Responsibilities: 

Cross-Functional Coordination 

• Support cross-functional planning and execution of CMC activities, ensuring alignment with Client’s product development and corporate objectives, in close partnership with Quality, Regulatory Affairs, Clinical Operations, Finance, and Program Management 
• Support coordination with external CDMOs, CROs, and device partner to track deliverables and manage communication 

CMC Planning & Timeline Management 

• Own CMC project plans and integrated timelines across all active workstreams (drug substance, drug product, device, analytical, packaging/labeling/distribution), keeping deliverable trackers current and stakeholders aligned on status 
• Drive proactive risk management across the CMC portfolio: identify dependencies and timeline deviations early, own the escalation path, and ensure mitigation plans and solutions are developed with relevant stakeholders 

Meeting Facilitation & Documentation 

• Facilitate routine CMC team meetings and cross-functional discussions; prepare agendas, track action items, and promote timely resolution of issues to keep programs on schedule 
• Prepare and distribute meeting minutes, action logs, and timeline updates to relevant stakeholders 
• Maintain CMC-related documentation and filing systems in support of regulatory submissions and internal governance 

Communication & Stakeholder Alignment 

• Assist in the preparation of presentations and project status updates for senior leadership review 
• Communicate clearly on priorities, progress, risks, and outcomes across internal and external teams 
• Create transparency across teams and stakeholders; facilitate decision-making by providing relevant context and insights 

Experience 

• 3–8 years of experience in CMC project management or coordination within the biotech or pharmaceutical industry 
• Experience operating in a fast-paced, matrixed biotech or specialty pharma environment, including drug-device combination products preferred 
• Experience supporting IND, NDA, or BLA submissions from a project management or coordination perspective preferred 
• Experience managing communication with Contract Manufacturing Organizations (CMOs) or Contract Research Organizations (CROs) 

Qualifications 

• Bachelor’s degree in life sciences, chemistry, engineering, or related field required 
• Working knowledge of CMC development processes across drug substance, drug product, and device workstreams 
• Understanding of CMC requirements for Phase I-III clinical development programs 
• Proficiency in project management tools (MS Project, Smartsheet, or equivalent) and Microsoft Office Suite (Word, Excel, PowerPoint) 
• Excellent planning and organizational skills with the ability to prioritize across a diverse workload; sound judgment and critical thinking 
• Strong written and verbal communication skills; comfortable interacting with stakeholders at all levels 
• Ability to work independently and collaboratively in a remote, cross-functional, and inclusive environment 
• Demonstrated biotech PM experience is weighted over formal certification; PMP is a plus but not required - candidates who have run live programs without one are equally competitive 

Position Impact 

This role is critical to how eQuilibrynt Consulting delivers value. Great programs do not fail because of science alone. They fail because of how the work is run. This position helps solve that problem by keeping CMC timelines organized, cross-functional teams aligned, and operational details from falling through the cracks — creating the order, clarity, and momentum needed for Client’s programs to succeed. 

At eQuilibrynt Consulting, we are building a better way to run drug development programs. The CMC Project Management Consultant will play a central role in making that vision real for the Client and the patients they serve.