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
Reporting to the Vice President of Technical Operations, Abcuro, Inc. is seeking a Senior Director of Supply Chain who has a strong supply chain management and strategy background. This role will manage clinical and commercial supply and CMC logistics. The Senior Director, Supply Chain will interface with a diverse team across Clinical Operations, Regulatory, Manufacturing, Quality, Commercial, and external partners to support critical tasks related to supply chain strategy and planning, shipping and logistics, labeling, packaging, storage, and distribution of clinical materials for global clinical trials. In addition, this person will be responsible for establishing the early commercial supply chain strategy and logistics.
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
- Overall responsibility for developing, implementing, and managing the supply chain strategy for both clinical and early commercial products.
- Develop demand and distribution plans along with management of inventory forecasting activities and production planning to meet global clinical trial demands.
- Oversee the labeling, packaging, and distribution of investigational drug supply, including point of contact for clinical trial sites.
- Develop and report out routine key performance indicators, including forecast accuracy, inventory levels, inventory reserve, monthly supply, and customer delivery performance.
- Oversee the development and management of supply plans of critical materials to support manufacturing runs and to ensure continuous, quality supply. Oversee the change control for raw materials as needed.
- Lead the development and implementation of a manual system like ERP for inventory management and planning.
- Provide oversight of deliveries between manufacturing sites and 3PL providers.
- Develop inventory and planning reports, including inventory reconciliation at 3PL provider.
- Support the evaluation, selection, and quality audit of logistic providers.
- Oversee the evaluation of shipping lanes, shipping configuration, and other logistic-related activities, including import/export activities.
- Author and review supply chain standard operating procedures and ensure these are well communicated and understood by the staff who would use them.
- Serve as internal lead for triaging product complaints, temperature excursions, etc. Investigate deviations to determine root causes and implement corrective actions.
- Design, develop, and implement the commercial supply chain plans to meet commercial needs, in collaboration with other colleagues.
- 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 with a certification in logistics or planning preferred.
- Experience in supply to and depot management in US, Europe, and other geographies relevant to Abcuro.
- 15+ years of relevant logistics, planning, or supply chain experience in pharmaceutical or biotech environments
- Demonstrated technical skills and aptitude for logistics and cold chain management, including process optimization and drug product delivery.
- Experience with both clinical and commercial supply chain development and implementation.
- Solid understanding of global clinical trials and the drug development process.
- Additional specific qualifications in clinical supplies demand and logistics/ or planning management, including APICs, CPIM, and related professional certifications preferred.
- In-depth knowledge of material requirements planning, production, and scheduling.
- Knowledge and understanding of international pharmaceutical shipping requirements.
- Experience in the development, implementation, and use of ERP systems is a plus.
- In-depth understanding of GxP, good distribution practices, good clinical practices, ICH, ISO, WHO, FDA and EMA regulations.
- Understanding of global pharmaceutical regulatory requirements.
- Experience working effectively with cross-functional teams in fast-paced, dynamic environments.
- Self-motivated and willing to adapt to perform tasks and work as business needs change.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within established timelines.
- Candidates must be authorized to work in the U.S.
Computer Skills
- Microsoft Office proficiency
- Familiar with basic data processing and analysis
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.