Sr. Manager / Associate Director, Clinical Supply Chain Management
Location: South San Francisco, California, United States
The Sr. Manager / Associate Director, Clinical Supply Chain Management will manage global supply chain and distribution of drug products for all on-going and new clinical programs at Assembly Biosciences. This individual will oversee supply chain management activities including: planning and coordinating packaging, labeling, distribution, reconciliation, and destruction of drug product for clinical studies. The Sr. Manager / Associate Director will interface between clinical, CMC and external CROs to actively develop and manage process ensuring timely, accurate and continuous supply to patients while reducing risk and minimizing waste.
- Work with Clinical Operations to understand clinical demand requirements and ensure alignment with CMC to supply plans and timelines
- Manage GMP inventory (both drug product and drug substance) throughout the supply chain, develop inventory reports, manage upcoming expiry and temperature excursions, and ensure drug accountability
- Support the evaluation, selection and quality audit of packaging/labeling and distribution vendors
- Coordinate daily activities with distribution vendors as required
- Serve as internal lead for triaging of product complaints, temperature excursions, and deviations originating from distribution vendors and clinical sites.
- Investigate deviations to determine root causes and implement corrective actions
- Ensure label text and proofs are in accordance with applicable regulations, product specifications, and clinical study protocols
- Support IRT user acceptance testing, supply strategy, and oversee ongoing supply activities in system
- Coordinate import/export activities and track shipments to depots and clinical sites.
- Ensure all necessary documentations are available to the clinical sites
- Develop supply chain management strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
- Work with Assembly QA/QC to establish internal SOPs for supply chain management related activities
- M.S. or B.S in scientific or health related field with 8+ years’ experience in Clinical Supply Chain Management in biotech or pharmaceutical industry
- Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP)
- Knowledge of IWRS/IRT system setup and functionality and proficiency with Excel modeling
- Knowledge and understanding of international pharmaceuticals shipping requirements
- Self-motivated, comfortable in fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Effective communication, interpersonal skills, collaboration and negotiation skills
- Highly organized and efficient, able to orchestrate multiple projects simultaneously
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly Bio’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology.
We believe our Microbiome platform represents a best in class approach to developing biopharmaceutical agents from live biotherapeutic products. ABI-M201, our lead program in mildly to moderately active ulcerative colitis (UC), is currently in a phase 1b clinical trial. This program is part of a broader collaboration we established with Allergan in 2017 for gastrointestinal programs such as UC, Crohn’s disease and Irritable Bowel Syndromes with potential total development and commercial milestones of up to $2.8 billion. Our internal pipeline comprises first in class or best in class live microbial biotherapeutic approaches in areas such as oncology, immune mediated and metabolic disorders, and other areas of high medical need.
We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add to our dynamic team of great people who are driven to transform the lives of patients.
Assembly Bio is headquartered in Carmel, Indiana, while the R&D headquarters is in South San Francisco. The Company also has a microbiome manufacturing facility in Groton, CT, and offices in China. Assembly Bio has a strong balance sheet having raised approximately $166 million in July 2018. We are positioned well to build the next phase of the Company toward global development and commercialization of our innovative medicines in HBV-cure and the Microbiome.
Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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