Abdera Therapeutics

Contractor – CMC Project Manager

Abdera Therapeutics

contract

Posted on:

Location Type: Remote

Location: United States

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Tech Stack

PMP

About the role

  • Lead cross-functional CMC project planning and execution from early development through commercialization
  • Develop and maintain integrated CMC project plans, timelines, budgets, and risk registers
  • Support program core teams in collaborating with program team lead
  • Track milestones, dependencies, and critical path activities; proactively identify and mitigate risks
  • Facilitate CMC team meetings, prepare agendas, document decisions, and drive follow-up actions
  • Serve as primary CMC point of contact for program teams and senior leadership
  • Plan and manage CMC contributions to regulatory submissions in collaboration with regulatory and program leads as needed
  • Oversee work with CDMOs and external partners, including scope, timelines, and deliverables
  • Prepare clear project updates, dashboards, and summaries
  • Support continuous improvement of CMC project management processes and tools
  • Other related duties as assigned.

Requirements

  • Bachelor’s degree in science, engineering, or related field (advanced degree preferred)
  • 5+ years of experience in CMC, technical operations, or pharmaceutical/biotech project management
  • Strong understanding of phase appropriate CMC development, manufacturing, and regulatory requirements
  • Proven ability to manage complex, cross-functional projects in a regulated environment
  • Experience working with CDMOs and external vendors
  • Excellent organizational, communication, and stakeholder-management skills
  • Proficiency with project management tools (e.g., MS Project, Smartsheet, or similar)
  • Experience supporting early to late-stage development programs
  • Familiarity with global regulatory expectations (FDA, EMA, ICH)
  • Experience working in start-up environment preferred
  • PMP or other project management certification
  • Experience in biologics, oncology, or manufacturing (as applicable).
Benefits
  • Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace
  • We prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CMC project planningproject managementregulatory submissionsrisk managementcross-functional project managementphase appropriate CMC developmentmanufacturing requirementsbiologicsoncologytechnical operations
Soft Skills
organizational skillscommunication skillsstakeholder managementleadershipcollaborationproblem-solvingfacilitationdecision-makingtime managementcontinuous improvement
Certifications
PMPproject management certification