Work Location: RTP, North Carolina, United States 
Job Category: Professionals
Organization: Biotech/Pharma 
Employee Status: Full-time 
Job Type: Full-time, Exempt

This role will be responsible for overseeing all current facilities management projects and identifying, designing, and creating new space for facility expansion.

• Facility design and renovation
• Construction project management
• Harmonization of facility engineering systems and maintenance and HSE procedures and practice
• Office accommodation
• Cleanroom manufacturing space
• Warehousing
• Ensure equipment life cycle maintenance, manufacturing facility cleaning activities planning timeliness, building maintenance, and enforcement of safety and security measures
• Develop and implement comprehensive engineering, maintenance, and facility strategy for multiple buildings as well as the supporting policies and procedures
• Partner with key stakeholders including Manufacturing, Technology Transfer and Support, Process Development, and Quality to meet user requirements and optimal functioning of all manufacturing, laboratory, and building spaces
• Act as a subject matter expert for review, approval, and updating of critical building documentation, including Architectural Plans/Drawings, Engineering Drawings, Piping & Instrumentation Drawings (PID), Facility Maps/Diagrams, GMP Process Drawings, IT Network Documentation/Diagrams.
• Compliance with all state, federal, and regulatory governing agencies

Qualifications 

• Leadership experience in designing, building, and validating facilities associated with phase 1 to 3 manufacturing, pre-positioned to be commercially compliant, inspection ready and licensable by USFDA and EMA health authorities
• Experience overseeing FDA regulated manufacturing facilities management projects
• Design and maintain clean room ISO 7 and above, GMP Calibration, Metrology, HVAC, electrical systems, plumbing systems
• Bachelor's Degree
• 5+ years of high-level managerial experience within one or more areas including Construction, Process, Engineering, Facilities/Engineering Maintenance
• 3+ years of Biotech experience

CARsgen Therapeutics is a privately held, clinical stage immune-oncology biotech company. The company’s leading programs set it apart from other CAR-T company by focusing on the development novel therapies for solid tumor treatment. CARsgen received FDA clearance of the first CAR-Claudin18.2 T cell therapy for advanced gastric and pancreatic cancer. At present, CARsgen has two ongoing phase 1 clinical trials in North America and four Phase 1 clinical trials in China. The company will provide its employee a very competitive compensation plan, including base salary, 401K, insurances, equity option, bonus, PTO, etc.