Contractor – CMC Project Manager

Project ManagerProject ManagerContractRemoteTeam 11-50H1B No SponsorCompany Site LinkedIn

Location

United States

Posted

42 days ago

Salary

Not specified

Bachelor Degree5 yrs expEnglishPMP

Job Description

• 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.

Job 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.