Reports to: CEO

Key Responsibilities

1. CMC Strategy & Overall Coordination Develop and execute the overall CMC strategy of the company. Oversee process development, CDMO based manufacturing, and quality management to align with the IND/BLA advancement timelines of various product pipelines.

2. Process Development and Scale up Lead process development, optimization, scale up, process characterization and technology transfer for CAR T products. Establish the CQA/CPP system to support cutting edge pipelines including dual targeted CAR T, universal CAR T and in vivo CAR T.

3. Quality System & QC Management Build a GMP  and ICH compliant quality management system. Oversee QA/QC functions, define release testing specifications, and manage deviations, changes, audits and regulatory inspections.

4. CDMO & Manufacturing Management Conduct CDMO screening, audit, contracting and day to day governance. Lead technology transfer, production planning, batch manufacturing and product release activities.

5. Regulatory Filing Support Draft, review and submit CMC modules; support IND/BLA submissions, regulatory inquiries and on site inspections.

6. Supply Chain & Cost Control Drive domestic substitution of critical raw materials and optimize the supply chain system. Reasonably control CMC related costs and budgets.

7. T eam & Cross functional Collaboration Manage the CMC team. Coordinate with R&D, regulatory affairs, clinical and other departments; formulate project plans and allocate resources.

Qualifications

1. Ph.D. in Bioengineering, Cell Biology, Immunology, Pharmaceutical Engineering or related disciplines. Overseas educational background is preferred. 

2. Minimum 8 year CMC experience in biopharmaceuticals, with at least 5 years of hands on CMC experience in CAR T field. 

3. Proven end to end CMC track record taking at least one cell therapy product from pre clinical through IND/BLA stages; familiar with CMC modules for IND filings and PPQ activities. 

4. In depth expertise in key CAR T process workflows: cell isolation and activation, viral / non viral transduction, gene editing, expansion & harvest, formulation and cryopreservation. 

5. Comprehensive understanding of cutting edge directions including dual targeted CAR T, universal CAR T and in vivo CAR T; practical project experience in at least two of these areas. 

6. Familiar with NMPA regulatory guidelines for cell therapy products; knowledge of FDA / EMA regulations is a plus. Well versed in GMP and ICH requirements. 

7. Hands on experience in CDMO screening, technology transfer and quality management. 

8. Proficiency in English as a working language. Results driven, self motivated, and capable of thriving in a start up environment.

How to Apply

Please submit your resume to info@skyemed.com

Please state "Position Applied + Your Name" in the email subject.

Reports to: CEO

Key Responsibilities

1. R&D Strategy and Pipeline Portfolio Planning Formulate the overall R&D strategy and pipeline roadmap for the company’s CAR T cell therapy products. Based on cutting edge science and unmet clinical needs, lead target discovery, molecular design, vector construction and decision making for early stage R&D project initiation. Ensure the R&D pipeline delivers scientific soundness, innovation and differentiated competitive advantages.

2. End to End Product R&D Management Oversee full cycle R&D of CAR T products spanning early discovery, pre clinical studies, IND submission and clinical trials. Lead proof of concept (POC) for key projects and resolve core technical bottlenecks such as cell functional stability, safety risks and scalable manufacturing. Enable effective translation from R&D outputs to clinical and commercial stage production.

3. Clinical Development Enablement Deeply contribute to clinical development strategy formulation for CAR T programs, including clinical trial protocol design, data interpretation and scientific decision making. Provide technical and scientific inputs from the R&D side to clinical studies and ensure seamless hand offs between R&D and clinical functions.

4. Cross functional Collaboration & Regulatory Engagement Work closely with CMC, clinical development, regulatory affairs and other internal teams. Represent R&D core stakeholders in communications with regulatory agencies including FDA and NMPA. Lead preparation and review of R&D related sections for IND, BLA and other regulatory submissions.

5. Team Building & Talent Development Build, lead and develop a high caliber R&D team covering molecular biology, cell biology, immunology, gene editing and related disciplines. Continuously improve team scientific competence and execution capability.

6. External Academic & Industry Partnerships Represent the company at international scientific conferences and industry forums to showcase R&D progress and technological innovations. Establish and maintain strategic partnerships with top academic institutions, KOLs and industry players globally.

Qualifications

Ph.D. from well recognized overseas universities in Cell Biology, Immunology, Molecular Biology, Oncology, Bioengineering or related disciplines. 

2. 10+ years of biopharmaceutical R&D experience, including a minimum of 5 years of direct hands on R&D experience in CAR T or broader cell and gene therapy (CGT) space. 

3. Demonstrated practical experience advancing CAR T assets from early stage research into clinical trial stages (IND and beyond). 

4. Solid theoretical foundation and experimental proficiency in CAR T cell therapy; expert knowledge of core technologies including CRISPR/Cas9 mediated gene editing, viral / non viral vector design & construction, and cellular engineering modification. 

5. Proven leadership managing cross disciplinary R&D teams, with track record of motivating high level scientists to solve complex technical challenges. 

6. Deep understanding of end to end cell therapy R&D workflows, key technical milestones, regulatory expectations and industry trends. 

7. Strong strategic thinking and scientific acumen; capable of identifying emerging scientific breakthroughs and translating them into actionable R&D opportunities. 

8. Excellent communication and negotiation skills. Fluent written and spoken English for international scientific exchanges.

How to Apply

Please submit your resume to info@skyemed.com

Please state "Position Applied + Your Name" in the email subject.