Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Supply Operations Manager within the Clinical Supply Chain organization to be based in Beerse, Belgium
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssen.com for more information.
The Clinical Supply Operations Manager will be responsible for planning and scheduling for individual patients between internal stakeholders (GCO, CSC, Logistics) and external stakeholders (clinical sites). The Clinical Supply Operations Manager will be the single point of contact (SPOC) for clinical sites for both CSC (Clinical Supply Chain) & Clinical Operations activities related to CAR-T treatment scheduling & triaging technical questions.
- Close coordination with GCO (Global Clinical Operations) team to understand site-based timings for new site initiations, planning and coordination of logistical test runs between Clinical Sites, CCPC (Central Cell Processing Center) & Manufacturing
- Provides site and study level training related to patient onboarding and all aspects of subject scheduling.
- For each patient identified for participation in a clinical trial, coordinates & tracks the patient journey, triaging any issues to appropriate stakeholders between apheresis & Investigational Product (IP) receipt on site.
- Provides regular updates on patient status & milestones, notifying internal and external stakeholders of any changes to the schedule with assessment of potential impact.
- Provides slot allotment & availability for apheresis to appropriate site personnel and collaborates with them to achieve approved apheresis date in light of Manufacturing and CCPC availability
- SPOC for CCPC(s), in providing real-time capacity utilization per patient enrollment across the compound and works to resolve any site level issues that might impact CCPC. Escalates any needs for increase to capacity to CSI, Operations Lead.
- Coordinates all Logistics Test Runs as well as any unused IP returns from site(s)
- Supports pro-actively in the continuous improvement of the overall supply chain processes.
- Comply with applicable Standard Operating Procedures (SOPs).
- Participates in GCP and GMP health authority inspections.
- Patient Journey Mapping; able to act as SPOC for any scheduling/logistic related activities & triage any product/Chain of Custody/Chain of Identity issues to appropriate stakeholders.
- A Bachelor’s Degree required, preferably in Life Sciences.
- Minimum of 4 years experience with working with clinical sites or closely related experience required.
- Clinical operational knowledge and experience is required.
- Ability to effectively apply project management tools when leading projects and programs is required. Knowledge of FPX is preferred.
- Experience in Cell and Gene Therapy Clinical Trials and/or Commercial Operations preferred.
- Good understanding of applicable regulations and standards pertaining to Cell and Gene Therapies (HTA, AABB, FACT-JACIE, CFRs) preferred.
- Understanding of planning, material handling, manufacturing, and GMP-compliance related to the manufacturing of biopharmaceuticals is preferred.
- Experience with systems including scheduling/logistics within Chain of Custody/Chain of Identity protocols is preferred.
- Experience embracing passion for patient care required.
- Excellent communication skills required.
- Adaptability and flexibility required.
- Exceptional creative and critical thinking, excellent decision-making and analytical abilities are required.
- Big picture orientation with attention to detail and results oriented are required.
- Ability to collaborate internally and work in a matrix environment required.
- Ability to work in a multi-cultural environment required.
- Experience working with external customers preferred.
Willingness and ability to travel up to 15-20% domestic US travel as defined by business needs required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Janssen Pharmaceutica N.V. (7555)