At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Supply Chain Deliver

Job Sub Function:

Deliver Excellence

Job Category:

Professional

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

Summary:

CAR-T commercial supply chain technician/supervisor is responsible to manage the contracts and communication with third party suppliers including the hospitals and cellular cryopreservation sites in APAC countries. This individual will support the establishment and implementation for apheresis and cryopreservation operations. The Cell Collection Technician/Supervisor will support together with local staff to support international staff training and qualifications to perform cell collection and cryopreservation and also support performing and concluding technical investigations into apheresis starting material deviations. Harmonizes internal stakeholder requirements with external stakeholder level of comprehension and performance level to deliver a fit for purpose tech transfer and implementation experience for the stakeholder. This role fully accountable to establish third party for the successful product deliver in Asia Pacific with a peak market size of 2,000 patients. Able to combine operational efficiency and speed with compliance.

Responsibilities:

• Support fit for purpose technical transfer for FACT/JACIE compliant commercial apheresis and cryopreservation of leukapheresis starting material.
• Perform tasks on time consistent with the safety policies, quality systems and FACT/JACIE and/or other regulatory compliant requirements.
• Ensures seamless flow of knowledge and information across commercial and manufacturing functions, as well as, with hospitals as suppliers
• Maintain site readiness and compliance by maintaining change controls and actively supporting regulatory inspections as necessary.
• Possibility of managing a line and/or matrix teams of 5-10 indirect reports
• Develop a cohesive internal stakeholder team (e.g. External Quality, Procurement and Subject Matter Experts)
• Develop working relationship with international delegates receiving the technical method transfer.
• Coordinate and assist with external site audits for apheresis and cell labs, support and/or develop SOP, and training for technicians/nurses as needed.
• Facilitates near-real-time apheresis and/or cryopreservation quality investigation when required.
• Deliver site-specific education and answers on-demand questions related to leukapheresis and cryopreservation.
• Coordinate Information Technology, Logistic transport and regulatory requirements affecting apheresis material and cryopreservation activities.
• Develop and monitor site performance metrics.
• Leads contracting, meetings with suppliers, and issuance of Purchase Orders (PO)

Qualifications:

• A bachelor’s degree in a scientific or engineering discipline is required.
• Project Management experience required.
• Ability to work independently and in a matrixed team environment is required.
• In addition to Japanese, fluency in English is required.
• Contracting and third-party management experience is preferred.
• First-hand experience in cryopreserving either fresh apheresis material, isolated cell populations or plasma/whole blood preferred.
• Extensive experience in successful tech transfers of complex lab processes is preferred.
• First-hand experience with cryopreservation methods for human mononuclear cells is preferred.
• 4 years of wet-lab research and development or cell processing laboratory experience is preferred.
• Experience being accountable to perform work following GTP, cGMP or GCP is preferred.
• Experience in writing, reviewing and implementing procedural and compliant documents is required.
• Working knowledge of JACIE or FACT immune effector cell handling requirements is required.
• Listening and communicating with cultural awareness, empathy and relatability
• Understanding of drug development and submission requirements is preferred.
• Manufacturing and logistics understanding/experience is preferred.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Ability to lift a minimum of 25 lbs. and to stand for a long period of time are required
• Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution is required.
• Work hours may require accommodation of up to a 17-hour time-zone difference with cryopreservation laboratory teams.

#LI-Hybrid

========================================================

社内公募ガイドライン

• 応募の際はAskGS内の社内公募ガイドラインをご一読いただき、応募ください。１８か月未満の方は応募前に上長及び担当BUHRの許可を取ってから応募ください。複数同時応募不可になります。

• 在籍期間に関わらず、書類選考を通して１次面接に進んだ場合は、社内公募に応募し選考に進むことを上司に報告してください。

• 社内紹介を行う場合は、Career Hub上の“社内紹介制度の概要”の詳細を理解した上で、コンプライアンスを守って紹介したものとみなします。

 

 

Required Skills:

 

 

Preferred Skills: