Position Summary:
The CMC Program Manager is responsible for the planning, coordination, and execution of Chemistry, Manufacturing, and Controls (CMC) activities across Atrium Therapeutics' development portfolio. This individual will serve as the operational lead for CMC program management, driving timelines, budgets, meeting governance, documentation management, and cross-functional coordination to ensure successful program execution from preclinical development through commercialization.
Reporting to the Technical Product Lead / Head of CMC Strategy, the CMC Program Manager will work closely with Technical Development, Manufacturing, Quality, Regulatory Affairs, Clinical Supply, and external CDMO partners to align CMC activities with overall program objectives. The role will chair CMC Team meetings, coordinate stage-gate governance, and ensure execution of critical deliverables across the product lifecycle.
The ideal candidate possesses a strong understanding of pharmaceutical development and CMC processes, exceptional project management skills, and the ability to drive complex cross-functional initiatives. For qualified candidates, the role offers the opportunity to progressively assume Technical Product Lead responsibilities for early-phase development programs.
Job Responsibilities:
• Develop, maintain, and communicate integrated CMC development plans across assigned programs.
• Drive planning, execution, and monitoring of CMC activities to support preclinical, clinical, and commercial milestones.
• Coordinate cross-functional teams to ensure alignment on priorities, deliverables, dependencies, and critical path activities.
• Proactively identify program risks, escalate issues, and facilitate development of mitigation strategies.
• Provide regular updates on program status, timelines, risks, and budget performance to Technical Development leadership and program teams.
• Support portfolio planning, resource management, and long-range development forecasting.
Timeline and Budget Management:
• Own and maintain CMC project timelines, milestones, and development schedules.
• Track critical path activities and ensure timely execution of key deliverables.
• Partner with functional leaders to develop, monitor, and manage program budgets.
• Track spending against approved budgets and identify potential variances or forecast changes.
• Support contract management, purchase order tracking, and budget planning for external development and manufacturing activities.
• Generate program metrics and dashboards to support leadership decision-making.
Documentation Management:
• Coordinate the authoring, review, approval, and archival of CMC technical documentation.
• Ensure timely completion of high-quality documentation supporting development, manufacturing, and regulatory activities.
• Manage document review workflows and coordinate contributions from cross-functional subject matter experts.
• Support preparation and review of:
o INDs, IMPDs, CTAs, BLAs, NDAs, and other regulatory submissions
o CMC strategies and development plans
o Process development reports
o Technology transfer documents
o Process Characterization and Validation documentation
o Specifications and analytical documentation
o Comparability packages
o Pharmacy manuals
o Manufacturing and supply chain documentation
• Maintain document trackers and ensure inspection-ready documentation practices.
Team Leadership and Governance:
• Chair CMC Team meetings for lead development programs.
• Develop meeting agendas, facilitate discussions, document decisions, and track action items to completion.
• Coordinate Stage Gate reviews and governance activities across development programs.
• Ensure alignment of CMC deliverables required for program advancement and governance decisions.
• Partner with Technical Product Leads and program leadership to prepare presentations and materials for governance committees and executive reviews.
• Facilitate communication and decision-making across cross-functional teams and external partners.
Cross-Functional Collaboration:
• Work closely with Technical Development, Manufacturing, Quality, Regulatory Affairs, Clinical Supply, and Finance teams.
• Coordinate interactions with CDMOs, contract testing laboratories, and development partners.
• Support regulatory filing activities and major program milestones.
• Ensure effective communication across internal and external stakeholders to drive timely execution of program deliverables.
Technical Product Leadership Development:
• Develop a broad understanding of Atrium's CMC development strategies and product portfolio.
• Participate in strategic program planning and governance activities.
• Gain experience representing Technical Operations on project teams.
• For qualified candidates, assume increasing responsibility as a Technical Product Lead for early-phase development programs under the guidance of the Head of CMC Strategy.
Education and Experience Requirements:
• 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.
• 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
• 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
• Collaborative and proactive leadership style
• Ability to manage multiple priorities in a fast-paced environment
• Strategic mindset with strong attention to detail
What We Provide:
• The base salary range for this role is $180,500 - $199,500 The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
• Atrium offers competitive compensation and benefits which include stock options & RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, LTD, and unlimited of time off including summer & winter breaks.
• A commitment to learning and development which includes a variety of programming internally developed by and for Atrium employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
$180,500 - $199,500 a year
