Abcuro, Inc. is a clinical-stage biotechnology company developing protein-based treatments for serious autoimmune and cancer indications modulated by cytotoxic T and NK cells that express the inhibitory immune checkpoint receptor KLRG1 (killer cell lectin-like receptor G1). The company is advancing ABC008, a first-in-class anti-KLRG1 antibody designed to deplete cytotoxic T cells that attack healthy muscle tissue in patients with inclusion body myositis (IBM), into clinical studies.
POSITION SUMMARY
Abucro, Inc. is seeking a Director, CMC Project Management. In this role you will be responsible for leading the projects to support CMC clinical trials and commercialization of Abcuro’s investigational products. Seasoned professionals to lead Chemistry, Manufacturing, and Controls (CMC) project management efforts for late-phase development and commercialization. The Director will facilitate a cross-functional diverse team across Technical Operation, Quality, Regulatory, Program Management, and external partners to support critical manufacturing tasks and ensure a seamless transition from late-phase development to commercial readiness, including Biologics License Application (BLA) submission. This role requires strategic leadership, strong project management expertise, and in-depth knowledge of regulatory requirements, product lifecycle management, and commercial manufacturing.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
Project Leadership
- Lead cross-functional CMC project teams through late-phase development, BLA submission, and commercial launch activities.
- Develop and execute CMC project plans, timelines, and budgets to align with program goals.
- Partner with stakeholders (R&D, QA, Regulatory, Manufacturing, Supply Chain) to ensure alignment and timely delivery of key milestones.
BLA Submission and Commercial Readiness
- Drive the preparation, review, and delivery of CMC sections of the BLA and other regulatory filings.
- Ensure compliance with global regulatory guidelines, including FDA, EMA, and ICH standards.
- Coordinate validation and scale-up of manufacturing processes, technology transfer, and quality systems for commercial readiness.
Risk and Resource Management
- Identify potential risks, challenges, and bottlenecks and implement mitigation strategies.
- Manage resource allocation across multiple programs, ensuring alignment with organizational priorities.
- Track progress and provide regular updates to executive leadership and key stakeholders.
Cross-Functional Collaboration
- Facilitate strong communication and collaboration among teams, ensuring technical, operational, and regulatory integration.
- Act as a liaison between internal teams and external partners, such as CDMOs, CROs, and regulatory agencies.
Leadership and Mentorship
- Provide leadership and mentorship to project management team members, fostering a high-performance culture.
- Contribute to the development and refinement of best practices for CMC project management and lifecycle management.
WORK EXPERIENCE
- 10+ years of experience in CMC project management within the biopharmaceutical or biotechnology industry.
- Demonstrated expertise in late-phase development, BLA submission, and commercialization.
- Strong understanding of cGMP manufacturing, regulatory requirements, and lifecycle management for biologics or pharmaceuticals.
- Experience managing global and cross-functional project teams.
- Proven ability to manage multiple complex projects and meet aggressive timelines.
- Strong analytical and problem-solving skills with a focus on strategic thinking.
- Excellent communication, organizational, and interpersonal skills.
- Proficiency in project management tools and methodologies (e.g., MS Project, Smartsheet).
- Certification in Project Management (PMP or equivalent).
- Experience with both biologics, monoclonal antibody preferred
- Prior involvement in commercial launches or lifecycle management for biologics, rare diseases, orphan drug preferred.
OTHER SKILLS
- Leadership: Ability to influence and lead diverse teams in a matrix environment.
- Decision-Making: Strong decision-making ability under tight timelines and high-pressure scenarios.
- Innovation: Forward-thinking approach to overcome challenges and improve processes.
If interested in this role, please email your resume to careers@abcuro.com.
Abcuro believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of any legally protected status. Abcuro will provide reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.