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Clinical Supplies Operations Manager - 2406192752W

Description

Clinical Supplies Operations Manager (1 of 2)

We are seeking a Supply Operations Manager, located within commutable distance of J&J sites in Beerse, Belgium or Horsham (Pennsylvania) or Titusville (New Jersey) US to join our Clinical Supplies Operations business. The Supply Operations Manager will oversee the coordination and scheduling of CAR-T treatment for individual patients, acting as the primary liaison between internal teams (Global Clinical Operations, Clinical Supply Chain, Logistics) and external clinical sites. This role entails managing all aspects of treatment scheduling and serving as the central point of contact for clinical sites, handling inquiries and coordinating technical aspects related to both Clinical Supply Chain and Clinical Operations activities.

Are you ready to join our team? Then read further!

Role & Responsibilities

• Close coordination with GCO team to understand site-based timings for new site initiations, planning and coordination of logistical test runs between Clinical Sites, CCPC & MFG

• 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 & 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

• Coordinates all Logistics Test Runs as well as any unused IP returns from site(s)

• Comply with applicable Standard Operating Procedures (SOPs).

• Patient Journey Mapping; able to act as SPOC for any scheduling/logistic related activities & triage any product/COC/COI issues to appropriate stakeholders.

Qualifications

Education & Experience

• A Bachelor’s Degree or equivalent required, preferably in Life Sciences.

• Minimum of 3 years experience with working with clinical sites or equivalent experience is required.

• Requires clinical operational knowledge, project planning, and good communication and influencing skills

• Must possess excellent decision-making and analytical abilities.

• Experience in Cell and Gene Therapy Clinical Trials and/or Commercial Operations

• Good understanding of applicable regulations and standards pertaining to Cell and Gene Therapies preferred (HTA, AABB, FACT-JACIE, CFRs)

• Ability to effectively apply project management tools to lead projects and programs is required. Knowledge of FPx is helpful.

• Understanding of planning, material handling, manufacturing, and GMP-compliance related to the manufacturing of biopharmaceuticals is helpful.

• Experience working with external customers

• Strong project management and team-working skills

• Big picture orientation with attention to detail

• Results oriented with ability to work collaboratively in a multi-cultural matrix environment

Benefits:

We offer a competitive salary and extensive benefits package. The health and well-being of our employees is a priority. We offer career development opportunities for those who want to grow and be part of our organisation. We are J&J Innovative Medicine!

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

Other Locations NA-US-Pennsylvania-Horsham, NA-US-New Jersey-Titusville

Organization Janssen Pharmaceutica N.V. (7555)

Job Function Clinical Supply Operations

Req ID: 2406192752W