Jasper is a clinical-stage biotechnology company developing briquilimab, a novel antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU or with CIndU and is initiating a clinical study in patients with asthma. Briquilimab is also currently in clinical studies as a treatment for patients with LR-MDS and as a conditioning agent for cell therapies for rare diseases. To date, briquilimab has a demonstrated efficacy and safety profile in more than 160 dosed participants and healthy volunteers, with clinical outcomes in CIndU, and as a conditioning agent in severe combined immunodeficiency (SCID), acute myeloid leukemia (AML), myelodysplastic syndromes (MDS), Fanconi anemia (FA), and sickle cell disease (SCD).
Job Summary- This is an individual contributor role & will report to the Senior Director of Supply Chain. We seek an experienced Supply Chain Manager responsible for managing investigational drug and ancillary supplies for assigned clinical studies, in coordination with Clinical Operations, CMC, Regulatory, Quality, and Finance teams. The ideal candidate will have 5+ years of experience in clinical supply chain management, with global experience preferred. The candidate will need to understand the drug development process and be able to independently forecast and manage supply and distribution needs for assigned clinical studies.
Responsibilities- Independently plan and manage all aspects of Investigational Product (IP) supply for assigned clinical studies including finished kit shipments.
- Liaise with interfaces and stakeholders internally and externally as required, to ensure highly effective clinical supply planning and execution, including ongoing responsiveness to any changes that may impact supply strategy.
- Manage and track IP and ancillary supply inventory; advise supply management team of potential shortages and make recommendations for resupply activities based on usage trends by performing routine forecasting/demand planning. Implement inventory control systems to optimize stock levels, minimize waste, and ensure availability of materials for production.
- Oversee IP shipment orders according to supply plans to ensure timely and compliant shipment and delivery to study sites from depots, from order request through acknowledgement of receipt by the site.
- Review drug return and destruction records; communicate with sites, CROs and external vendors to resolve issues.
- Perform 100% drug accountability and reconciliation from bulk drug, production, distribution, and returns/destruction.
- Monitor IP expiry data and inform CMC team of pending IP expiry needs.
- Ensure all regulatory & quality relevant changes for clinical trial material are taken into account within the supply plan.
- Ensure compliance with relevant regulations and standards related to supply chain and logistics operations, such as Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.
Requirements- Bachelors or Master’s degree in basic/applied sciences, engineering, supply chain management, logistics, business administration, or a related field.
- Proven experience (typically 5+ years) in supply chain management, logistics, or procurement, preferably in the biotech or pharmaceutical industry.
- Strong knowledge of global supply chain considerations (manufacturing, quality, analytics, regulatory, finance, clinical operations) for clinical trial material.
- Advanced expertise with IRT software for inventory and shipment management of IMP.
- Advanced understanding of drug development process, clinical trial design, drug technical development, drug demand forecasting and supply planning techniques.
- Demonstrated ability to work independently and collaboratively with cross-functional teams, including Clinical Supply Chain, Clinical Operations, CMC, Regulatory, Quality, and Finance teams.
- Proficiency in GMP/GCP processes, labeling, and import/export requirements for clinical supplies.
- Strong organizational and project management skills, including ability to multitask and organize/track information.
- Strong analytical, logic and problem solving skills, with advanced knowledge of Excel.
- Excellent written and verbal communication and presentation skills.
- Independent self-starter, with ability to lead ad hoc teams, perform work without supervision and show good judgment in determining objectives and approaches to assignments.
$125,000 - $160,000 a year
We offer our employees comprehensive benefits.
Jasper is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
Company Values:
· Respect
· Collaboration
· Integrity
· Responsible
· Excellence
· Acknowledgment
Mission:
Our mission is to make safer and potentially curative therapy possible for more patients in need. We are bringing together a team of high performing biotech professionals, leading academic institutions and a strong syndicate of healthcare-focused investors to achieve our vision