The Project Manager – CMC is responsible for planning, coordinating, and tracking activities related to the development and manufacturing of biological drug substances and drug products, including coformulations and clinical supplies. This role works closely with cross-functional teams, such as, but not limited to Drug Substance Development, Drug Product Formulation, Analytical Development, Clinical Development, Regulatory Affairs, Business Development and Quality—to ensure project timelines, budgets, and deliverables are met in alignment with company goals and regulatory standards. The ideal candidate has a strong background in biopharmaceutical development, with experience working at or collaborating with CDMOs, and a proven ability to manage complex CMC workflows through various development stages.   

 

Principal Duties and Responsibilities include the following:

  • Manage and track progress of CMC-related projects across drug substance and drug product development, coformulation activities, and clinical manufacturing campaigns.
  • Develop integrated project timelines, identify critical paths, and proactively manage risks and mitigation plans.
  • Coordinate with internal teams and external CDMOs/CROs to ensure alignment on technical and operational activities.
  • Maintain and update project dashboards and management tools to ensure transparency and effective communication.
  • Ensure project documentation, meeting minutes, action items, and timelines are maintained and accessible.
  • Support cross-functional alignment between formulation, analytical, manufacturing, quality, and regulatory teams.
  • Organize and lead regular team meetings to drive accountability and resolve roadblocks.
  • Collaborate with Logistics and Quality to ensure timely delivery and release of clinical materials.
  • Provide regular updates to leadership on project status, risks, and key decisions.
  • Support budgeting and resource planning efforts tied to CMC programs and execution.
  • Manage multiple projects involving pharmaceuticals in all phases of development.
  • Drive and manage the day-to-day activities associated with multiple projects
  • Guide and direct teams to keep projects on schedule.
  • Manage, forecast and track all project related materials including but not limited to, schedules, expenses and supply chain activities.

 

Qualification Requirements

 

Education:

  • Bachelor’s degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related field required.
  • PMP or other Project Management certification preferred.

 

Experience:

  • 5+ years of project management experience in the biopharmaceutical industry, with a focus on CMC preferred.
  • Strong experience working with or at CDMOs in biologic drug development projects.
  • Familiarity with GMP regulations, IND/IMPD-enabling activities, and clinical supply manufacturing.
  • Experience coordinating cross-functional CMC teams and tracking activities related to formulation, analytical method development, tech transfer, and process validation.

 

Knowledge/Skill:

 

  • Proficient in project management tools (e.g., MS Project, Smartsheet, Asana).
  • Strong organizational and time management skills.
  • Excellent communication and interpersonal skills.
  • Demonstrated ability to work independently and lead cross-functional teams.
  • Understanding of regulatory expectations for CMC activities and documentation (e.g., Module 3).
  • Ability to handle multiple projects and priorities in a dynamic environment.
  • Skilled in managing multiple priorities and projects, working in a fast-paced environment.
  • Excellent verbal and writing communication skills.
  • Self-motivated and proactive work ethic.

 

Working Conditions: Specify work environment:

 

  • The work environment shall be hybrid with work from home and onsite meetings at company headquarters (Fort Lauderdale, FL) or CDMO partner sites as needed.
  • Domestic & International travel up to 25%
  • Regularly required to stand, sit, talk, hear, and use hands
  • Prolonged periods of sitting and standing

 

Syncromune is an Equal Opportunity Employer.

 

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to, the primary work location and the chosen candidate’s relevant skills, experience, and education.

 

Expected US salary range: $135,000-$165,000

 

This position generally is eligible for cash incentive compensation, equity incentive compensation, and employee benefits under the Company’s benefit plans.

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