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.
Reporting to the Vice President of Technical Operations, Abcuro is seeking a Senior Manager for Project Management and operations with a strong technical drug development background to support its Chemistry, Manufacturing, and Controls (CMC) team. The Sr. Manager, CMC Project Management will work closely with the CMC team to provide project management for ongoing development programs as well as coordination of operations including tracking of CMC key deliverables and dashboard. As a member of the CMC team, this person will closely collaborate with Quality, Regulatory, Program Management and others on the project team, as well as key external parties. Abcuro offers a dynamic and highly collaborative work environment with a generous compensation and benefits package. We welcome inquiries from qualified, enthusiastic candidates with a passion for excellence.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
- Integrate detailed execution and long-term development plans across the various CMC and Technical Operations areas, including Analytical Development, Drug Substance and Product Development, GMP Manufacturing, Supply Chain and Logistics for Abcuro’s programs.
- Prepare plans and timelines based on input from CMC team including production and testing timelines with external vendors. Create planning charts using Gantt, Microsoft project software or other project management software. Tracks tasks and completion status.
- Schedule and coordinate CMC meetings, agendas, and minutes including those with external vendors to ensure timely communication and identification of key deliverables.
- Management of drug substance and drug product inventory, shipping and CMC documents.
- Track CMC key activities and maintain dashboard including development and manufacture of drug substance, drug product, regulatory filings, and shipping to ensure on time delivery of CMC objectives.
- Work closely with Abcuro’s Program Management group and project teams to ensure seamless communication and integration of plans into the larger program plan.
- Support the evaluation and selection of CDMOs from the project management perspective.
- Ensure all necessary documentation is provided and available to CDMO and Abcuro.
- Coordinate the review and approval of batch record review with Technical Operations and Quality.
- Facilitate the routing of legal documents such as Master Service Agreements (MSAs), Scope of Work (SOW), and other routine documents requiring review and approval by CMC and others.
- Facilitate review and approval of vendor invoicing with CMC and Finance including establishment of PO’s.
- Perform other duties as assigned.
EDUCATION AND WORK EXPERIENCE
- Bachelor’s Degree or above in Life Sciences, project management or related business administration is required. Experience in rare disease preferred.
- Good understanding of GXP, ICH, ISO, WHO, FDA and EMA regulations.
- 5+ years of relevant project management experience in a pharmaceutical or biotech company.
- Knowledge of the drug development process including conduct of global clinical trials.
- Experience working effectively with cross-functional teams in a fast-paced, dynamic environment.
- Self-driven and flexible to conduct work tasks outside of the initial job description scope if needed for project program success.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment and in this role.
- Comfortable in a fast-paced small company environment; and able to adjust workload based upon evolving priorities.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
- Microsoft Office proficiency and familiarity with basic project management tools like MS project, PowerPoint Timeline, Excel, and other related tools.
- Must be authorized to work in the U.S.
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 make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
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