CMC Project Coordinator

Job Description

The CMC Project Coordinator supports cross-functional Chemistry, Manufacturing, and Controls (CMC) initiatives by building and maintaining integrated project plans, tracking timelines and deliverables, and ensuring clear communication across quality control, analytical development, regulatory, and external partners. This role focuses on coordinating assay development and validation activities, managing sample logistics, and maintaining dashboards that provide visibility into overall project health. The position offers strong exposure to the drug development lifecycle and the opportunity to grow into a Project Manager role within a collaborative and fast-growing biotech environment.

Responsibilities

• Build and maintain integrated project timelines that align with program milestones and overall development strategies.
• Track project deliverables, dependencies, and critical paths to ensure on-time execution of CMC activities.
• Monitor milestone progress and proactively identify risks, dependencies, and delays, escalating issues as needed.
• Support development and maintenance of comprehensive project plans that integrate cross-functional inputs.
• Facilitate cross-functional meetings and working sessions, ensuring clear agendas, structured discussions, and timely follow-up.
• Document meeting notes, decisions, risks, action items, and outcomes, and distribute them to relevant stakeholders.
• Coordinate communication across quality control, analytical development, regulatory, and external partners to maintain alignment.
• Track assay progress across development, qualification, and validation phases, ensuring accurate status visibility.
• Monitor validation activities and sample workflows to support CMC and analytical development objectives.
• Manage sample logistics and status tracking, including coordination of sample movement and documentation across laboratory workflows.
• Maintain dashboards and reporting tools that provide real-time visibility into project and program health.
• Develop and update status trackers to monitor key performance indicators, timelines, and deliverables.
• Provide regular project updates and summarized reports to leadership and stakeholders.
• Translate technical workflows and scientific processes into structured project plans and schedules using project management tools.
• Partner closely with quality control and analytical development teams to monitor execution progress and resolve issues.
• Use project management software such as Smartsheet, Excel, Office Timeline, or similar tools to organize, visualize, and communicate project information.
• Support continuous improvement of project coordination practices, documentation standards, and communication processes.
• Manage multiple priorities in a fast-paced environment while maintaining high standards of organization and follow-through.

Essential Skills

• 1-3 years of experience in project coordination, project management, or scientific operations, preferably within biotech or pharmaceutical environments.
• Experience in biotech or pharmaceutical settings with exposure to CMC, quality control, or analytical development functions.
• Understanding of the assay lifecycle, including development, qualification, and validation stages.
• Familiarity with laboratory workflows and sample tracking processes, including sample lifecycle management.
• Demonstrated ability to build and maintain integrated project timelines aligned to program milestones.
• Proven experience tracking deliverables, dependencies, and critical paths, and escalating scheduling issues when necessary.
• Strong skills in facilitating cross-functional meetings and working sessions and coordinating stakeholder updates.
• Ability to document decisions, risks, action items, and outcomes clearly and accurately.
• Experience with project management tools such as Smartsheet, Excel, Office Timeline, or similar platforms.
• Ability to translate technical and scientific workflows into structured project plans and schedules.
• Strong organizational and time management skills with the ability to manage multiple priorities.
• Excellent written and verbal communication skills for effective interaction with cross-functional teams and leadership.
• Attention to detail in tracking data, maintaining dashboards, and reporting on project health and key performance indicators.

Additional Skills & Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• Experience developing dashboards and status trackers to monitor program health and KPIs.
• Experience providing regular project updates and summaries to leadership and stakeholders.
• Comfort working in a fast-paced, growth-oriented biotech environment.
• Interest in and aptitude for growing into a Project Manager role over time.
• Ability to work collaboratively with quality control, analytical development, regulatory, and external partners.
• Proactive mindset with the ability to identify risks and propose mitigation strategies.
• Strong cross-functional visibility and interest in the broader drug development lifecycle.

Work Environment

This is a fully remote position with a preference for candidates who can work east coast business hours. The role relies heavily on virtual collaboration tools and project management software such as Smartsheet, Excel, and Office Timeline to coordinate work, track timelines, and maintain dashboards. You will interact regularly with cross-functional teams in quality control, analytical development, regulatory, and external partners in a collaborative, fast-growing biotech environment that values clear communication, ownership of deliverables, and continuous improvement.

Job Type & Location

• Type: Contract
• Location: Charlestown, MA (Hybrid)

Pay and Benefits

• Pay Range: $48.00 - $57.00/hr.
• Benefits: Medical, dental & vision, 401(k), disability, PTO, and more (eligibility requirements apply).

Application Deadline

This position is anticipated to close on Jun 12, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market.

Actalent is an equal opportunity employer. If you would like to request a reasonable accommodation, please email [email protected].