Contractor - CMC Project Manager

Abdera Therapeutics•South San Francisco, CA

About The Position

Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells. Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options. Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy! What we look for At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are relentless in our focus to offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face. We are building an exciting and fast paced company passionate about discovering and developing tomorrow’s most innovative cancer therapies. Abdera is seeking a CMC Project Manager, Contractor who will support and coordinate CMC activities across development programs.

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)
Ability and drive to creatively solve practical problems
Excellent written and verbal communication and strong organizational and time management skills
Strong execution and follow-through
Ability to balance detail with big-picture program objectives
Comfortable operating in fast-paced environment
Strong sense of planning and prioritization, and the ability to work with all levels of management
Detail oriented, exceptional documentation practices, technical writing and oral communication skills, ability to identify, communicate and recommend solutions to complex problems
Collaborative, proactive, and solutions-oriented mindset

Nice To Haves

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)

Responsibilities

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.