Senior CMC Project Manager

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $135k - $150k / year

⏰ Full Time

🟠 Senior

👷‍♀️ Project Manager

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Enveda

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $150M Series D - Enveda Biosciences on 2025-09

Healthcare • Consulting • Manufacturing

Enveda is a biotechnology company that leverages a proprietary platform to decode and translate nature’s chemical diversity for accelerated small-molecule drug discovery. By rapidly purifying, identifying, and characterizing molecules from complex natural sources, Enveda aims to put vast, evolutionarily derived chemical space into the hands of drug hunters to discover medicines faster and expand the pipeline of therapeutics.

📋 Description

• Lead program-level and portfolio-level planning and execution of CMC development for multiple small-molecule assets from initial tox supplies through scale-up across drug substance and drug product • Develop and own detailed CMC project plans and risk registers • Define and track development strategies, timelines, and deliverables with internal and external teams • Serve as the day-to-day primary point of contact for external CDMOs across China, the EU, and the US • Oversee CRO and CDMO planning, manufacturing campaign and batch execution timelines, and documentation deliverables • Organize and chair recurring cross-functional and CDMO meetings, including agendas, minutes, action items, and decision documentation • Communicate project status, risks, and mitigation strategies to internal teams and external partners • Own the CMC proposal, purchase order, and change order pipeline • Maintain a rolling multi-year CMC budget forecast and historical spend model, overseeing commitments, accruals, and variance analysis • Operate and improve a controlled, multi-stage CMC document review workflow • Identify opportunities to accelerate timelines, streamline execution, and anticipate resourcing needs

🎯 Requirements

• B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a similar field; M.S. or Ph.D. preferred • PMP certification is a plus • 5+ years of CMC project management experience in biotech or pharma • Hands-on exposure to small-molecule drug substance and drug product development from IND-enabling through early clinical phases; late-stage development experience is a plus • Familiarity with small-molecule drug development, including analytical method development, process chemistry, formulation, and regulatory documentation • Experience managing external CROs and CDMOs across multiple geographies, including planning, communication, quality of deliverables, and issue escalation and closure • Demonstrated ability to lead cross-functional initiatives, set priorities, and manage timelines and budgets in a resource-constrained, fast-paced environment • Proven ability to design and operate structured document workflows, approval processes, and standards in a GxP and submission-relevant context • Experience or strong interest in applying AI and automation to operational workflows, with an emphasis on safety, transparency, and human oversight • Strong technical and operational aptitude with Smartsheet, Box, Domo, Slack, and Zoom; comfort building or owning custom applications and integrations • Excellent oral and written communication skills • Fast-paced, results- and team-oriented start-up mindset, with flexibility, adaptability, resourcefulness, and excellent organizational, interpersonal, and problem-solving skills

🏖️ Benefits

• Medical, dental, and vision covered at 90% • 401(k) with company match • Flexible PTO • Company-wide weeklong recharge break • Adoption assistance

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