Associate Director, CMC Project Management

Atrium Therapeutics

. Develop, maintain, and communicate integrated CMC development plans across assigned programs .

Posted 10/13/2026full-timeSan Diego • California • United StatesSenior💰 $180,500 - $199,500 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in CMC development, project management, and regulatory submissions, with a strong focus on cross-functional collaboration and risk management. Proven ability to manage complex development programs and drive execution in a fast-paced environment.

Highest-signal resume keywords

CMC DevelopmentProject ManagementRegulatory SubmissionsBudget ManagementCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Pharmaceutical DevelopmentTechnical OperationsProcess DevelopmentManufacturing Science & TechnologyRisk ManagementStage-Gate GovernanceGMP ComplianceOligonucleotide DevelopmentBioconjugate DevelopmentBiologic Development

Soft Skills

Organizational SkillsLeadership CapabilitiesCommunication SkillsMeeting FacilitationStrategic Mindset

Tools & Technologies

Document TrackersProgram Metrics DashboardsGovernance Committee MaterialsDevelopment Planning ToolsBudget Tracking Systems

Certifications & Qualifications

PMP Certification

Industry Keywords

Pharmaceutical SciencesBiotechnology DevelopmentClinical ManufacturingProduct Lifecycle ManagementRegulatory Affairs

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Develop, maintain, and communicate integrated CMC development plans across assigned programs
Drive planning, execution, and monitoring of CMC activities supporting preclinical, clinical, and commercial milestones
Coordinate cross-functional teams on priorities, deliverables, dependencies, and critical path activities
Identify program risks, escalate issues, and facilitate mitigation strategies
Provide updates on program status, timelines, risks, and budget performance to leadership and program teams
Support portfolio planning, resource management, and long-range development forecasting
Own CMC project timelines, milestones, and development schedules
Track critical path activities, budgets, spending, variances, contracts, purchase orders, and external development/manufacturing planning
Generate program metrics and dashboards
Coordinate authoring, review, approval, and archival of CMC technical documentation
Support preparation and review of regulatory submissions, CMC strategies, process development reports, technology transfer documents, validation documentation, specifications, comparability packages, pharmacy manuals, and manufacturing and supply chain documentation
Maintain document trackers and inspection-ready documentation practices
Chair CMC Team meetings and facilitate agendas, decisions, and action items
Coordinate Stage Gate reviews and governance activities
Prepare governance committee and executive review materials
Collaborate with Technical Development, Manufacturing, Quality, Regulatory Affairs, Clinical Supply, Finance, CDMOs, contract testing laboratories, and development partners
Support regulatory filing activities and major program milestones
Develop understanding of CMC strategies and product portfolio
Participate in strategic program planning and governance
Represent Technical Operations on project teams
Potentially assume increasing Technical Product Lead responsibility for early-phase programs

Requirements

What you’ll need

Bachelor's degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biology, or related scientific discipline required
Advanced degree (MS, MBA, or PhD) preferred
5-10 years of experience in pharmaceutical or biotechnology development, Technical Operations, CMC, program management, manufacturing, or related functions
Demonstrated experience managing complex cross-functional development programs
Experience supporting pharmaceutical development programs from early-stage development through clinical manufacturing
Understanding of CMC development, manufacturing, regulatory submissions, and product lifecycle management
Experience working with external CDMOs and development partners preferred
Experience managing budgets, timelines, and project governance processes
Experience in oligonucleotide, bioconjugate, biologic, or advanced therapeutic development
Familiarity with Process Development, Manufacturing Science & Technology (MS&T), Process Characterization, Process Validation, and Technology Transfer activities
Experience supporting IND, IMPD, NDA, and/or BLA submissions
PMP certification or equivalent project management training is a plus
Knowledge of CMC development processes, pharmaceutical project management, clinical and commercial manufacturing operations, product development lifecycle management, regulatory submission support, budget and resource planning, risk management, stage-gate governance processes, and GMP and regulatory requirements
Exceptional project and program management skills
Strong organizational and planning abilities
Ability to drive execution in a matrixed environment
Excellent written and verbal communication skills
Strong meeting facilitation and leadership capabilities
Financial and budget management skills
Risk identification and mitigation planning
Ability to manage multiple priorities in a fast-paced environment
Strategic mindset with strong attention to detail

Benefits

Comp & perks

Stock options & RSUs
401(k) with an employer match
Wellness program
Medical coverage
Dental coverage
Vision coverage
LTD coverage
Unlimited time off, including summer & winter breaks
Internally developed learning and development programming
Job-specific training offered by industry
Education reimbursement program