Sr. Manager, Cell Therapy Operations

Mar 23, 2021

Job Description

Responsibility for ensuring high quality consistent supply of human cells & tissues (HCT) intended for use as manufacturing starting material in GMP manufacturing of cell therapy products through selection, approval, initiation, monitoring, and supply from hospitals/sites that will collect and process HCT, and for supporting the efficient and effective qualification and ongoing support of key treatment and apheresis centers

• Lead onboarding of sites, with accountability as the primary technical operations point of contact, and ensure ongoing operations are according to Novartis requirements.
• Verify sites comply with applicable requlatioins/accreditations, and ensure HCT capabilities and capacity in coordination with Sr. Cell Operations Manager, Apheresis QA and Local QA/RA
• Ensure business and quality agreements are implemented and maintained. Maintain clear technical/operational requirements (i.e., specifications, manuals, SOPs)
• Deliver and support training of sites to Novartis requirements
• Coordinate internally for site quality assessments, audits, inspections, and perform operations performance reviews (i.e., collecting data on trends, KPI, and driving continuous improvement)
• Key point of contact externally for all technical questions on apheresis and cryopreservation
• Management of control, deviations, investigations, and CAPA
• Support or lead supply chain coordination and scheduling activities
• Support implementation of new operational initiatives, updated training materials, processes and system updated including strategic projects led by the Business Unit to improve operations in Cell Therapy Centers

Within the organization:
• Support implementation and maintenance of local SOPs.
• Ensure management is kept informed of all critical and major issues.
• Ensure coordinated contact and collaboration is maintained with other functions (e.g. QA, Clinical, Sourcing, Legal, Supply Chain, Regulatory, Manufacturing Operations).
• Coordinate with other field personnel on ongoing site needs.

Personal development and People development
• Maintain current knowledge of regulatory requirements for HCT
• Maintain knowledge of latest collection and preservation techniques

Minimum Requirements

 Minimum Bachelor’s degree in Science (Biology, Biochemistry, Virology, Microbiology) and/or Medical. A professional certification in the field of auditing or compliance would also be advantageous

 10+ years of GxP pharmaceutical experience or at least 3 years pharmaceutical experience and experience in GTP, with at least 5 years of external partner facing role experience and/or leadership experience in healthcare
 Working with international blood/tissue requirements with understanding of drug development and submission requirements, and commercial material/product expectations.
 Manufacturing and logistics understanding/experience
 Direct experience performing apheresis, blood or tissue collection, or cryopreservation operations preferred, with demonstrated ability to engage on medical topics with confidence while balancing an operational mindset

 Innovative and strategic thinker with broad vision
 Ability to work independently and in a matrixed team environment when immediate internal feedback is not always available.
 Ability to make decisions independently in a rapidly changing competitive landscape.
 Strong interpersonal skills / emotional intelligence / presentation and communication skills.
 Flexibility to adapt to changing situations, ability to prioritize tasks according to objectives, and provide problem resolution.
 Strong quality mindset required
 Strong organizational skills
 Direct experience performing apheresis, blood or tissue collection, or cryopreservation operations is a plus.
 May require up to 70% travel primarily within China.
Technical Operations
Full Time
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Sr. Manager, Cell Therapy Operations

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