CMC Project Manager
- Be the outward focused contact that coordinates interactions with CMO’s, contracted services, and CRO’s for protein therapeutics.
- Manage external CMO partners by determining need, identifying sources of information for contracts and obtaining internal and external approvals for manufacturing service agreements (MSA’s), contracts, and amendments.
- Develop and maintain CMC timelines and track documentation related to process development reports and manufacturing batch records.
- Create working and productive internal, cross-functional relationships within CMC and Quality as well as representatives from other functions (e.g. clinical development, regulatory, legal, finance, etc.) focusing on communicating needs, deliverables and timelines.
- Develop and improve upon current document tracking system for managing CMC documents and recording CMC Tasks.
- Maintain and update budget for outside spend with CMOs and CROs to ensure payments are made and maintain ongoing communication with Finance on CMO expenses and timing.
- Organize and run CMC operational meetings providing clear agendas, minutes, decisions, and action items with appropriate follow-up for timeline changes and individual action items.
- Coordination of international and domestic GMP shipments for manufacture, packaging & labeling, and analytical testing.
- Develop and maintain CMC project dashboards for pre-clinical and clinical-stage molecules.
- Maintain current inventory list for raw materials, drug substance, drug product, master cell bank and reference standard across all programs
EDUCATION AND EXPERIENCE:
- BS or MS with 3+ yrs experience with Biotech/Pharma space; Familiarity with protein therapeutic process development and manufacture is preferred.
- Knowledge of the biotechnology product CMC projects, including state-of-the-art processes and instruments used to make material.
- The ability to work within a quality system is required.
- Exceptional analytical and problem-solving skills.
- Scientific and/or technical knowledge pertaining to biopharmaceutical development. Some hands-on experience with upstream, downstream, and/or analytical process development activities preferred.
- Demonstrated ability to interact on multiple projects and work with external contract organizations.
- Solid communication skills; comfortably representing the company, including scientific understanding of CMC activities, and provide that vision to internal and external partners.
- Demonstrated leadership skills and personal leadership style that fosters trust, confidence, and collaboration.
- Open-minded and risk-tolerant; not afraid to express opinions.