Senior CMC Project Manager

Enveda

. 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 .

Posted 11/4/2026full-timeRemote • United StatesSenior💰 $135,000 - $150,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC project management for small-molecule drug development, including planning, execution, and oversight of external partnerships. Proficient in managing budgets, timelines, and cross-functional communication in a fast-paced environment.

Highest-signal resume keywords

CMC Project ManagementSmall-Molecule Drug DevelopmentCross-Functional LeadershipRegulatory DocumentationBudget Forecasting

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project PlanningRisk ManagementAnalytical Method DevelopmentProcess ChemistryFormulation DevelopmentGxP ComplianceDocument Workflow DesignIssue EscalationQuality AssuranceVariance Analysis

Soft Skills

Excellent CommunicationOrganizational SkillsInterpersonal SkillsProblem-Solving SkillsAdaptability

Tools & Technologies

SmartsheetBoxDomoSlackZoom

Certifications & Qualifications

PMP Certification

Industry Keywords

BiotechPharmaceuticalsCRO ManagementCDMO ManagementIND-Enabling

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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