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7 days old

Clinical Supply Manager,Immuno-Oncology Sponsor

Kelly Services
Houston, TX 77007
**Clinical Supply Manager, Immuno-Oncology Sponsor**


**Houston, TX**


**Direct Hire/Perm**


Oncology-focused biotech developing targeted immunotherapies with an emphasis on treating solid tumors through two distinct therapeutic modalities with a wholly owned pipeline comprised of seven therapeutic programs, of which three are in clinical trials and four are in preclinical development.


The main responsibilities of this position will include but are not limited to the following tasks:


+ Global business process owner across all clinical sites for the following entities of cell therapy supply chain

+ Accountability to align our clinical site and vendors to enable a seamless and short end-to-end patient flow Leukapheresis PBMC intermediate from leukapheresis Investigational Medicinal Product Non- Investigational Medicinal Product n-IMP

+ Accountability to deliver the business process by collaborating with multiple stakeholders Internal: Clinical Sciences, Clinical Operations, Medical, GMP Operations, Quality Control, Quality Assurance, Biomarkers External: Clinical site, manufacturing and logistics vendors

+ Lead cross-functionally on planning, forecasting, prioritization and escalation of patient material through patient journey to enable a short end-to-end time.

+ Activate and manage patient registration and study flow in software platform. Coordinate leukapheresis and manufacturing slot allocation, sample shipment and logistics.

+ Maintain accountability for chain of identity, custody and temperature deviations during shipments, support deviations and develop CAPAs.

+ Interface with clinical operations to forecast patient infusions and align drug product delivery at the clinical site.

+ Maintain accountability for adequate packaging inventory, customs documentation and current import licenses.

+ Manage third-party vendors, contract, budget, invoice, provide on call coverage for vendors critical to patient journey.

+ Support clinical operations and CMC to enable new clinical site qualification and training for leukapheresis.

+ Manage clinical site shipping qualification and training on most current SOPs for leukapheresis and drug product shipments.

+ Build the pivotal/commercial model for operationalization of cell therapy Develop a process that is globally harmonized to provide oversight of n-IMP inventory at clinical sites.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-10 Expires: 2021-10-11

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Clinical Supply Manager,Immuno-Oncology Sponsor

Kelly Services
Houston, TX 77007

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