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US Site Head
2 months ago
Job Scope:
This site head position is responsible for leading a cross-functional team, including but not limited to Manufacturing, Supply Chain and Facility Operations of individual functional leaders to ensure alignment between departmental objectives and the site’s capabilities. He/she serves as the main point of contact for site operations for both internal and external interactions.
Essential responsibilities:
- Oversee GMP manufacturing facility consisting of design, construction, validation of facility, and supply chain system and operations.
- Oversee the preparation and management of complex GMP manufacturing facility development plans, budgets, and long-range planning
- Oversee full-scale operations in a multi-product GMP facility, manage and control production schedule
- Collaborate with Quality and PD/MSAT teams to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections
- Works with C-level executives to set annual strategic initiatives and ensure alignment with company goals
- Build an "intelligence" capability of developing innovative gene therapy products, such as novel target and indications discovery, vector development, therapeutic strategy design, efficacy evaluation, vector manufacturing and clinical trial design
- Perform other duties as assigned based on business needs
Qualifications:
- Bachelor’s degree or above in biological science, chemistry or a related discipline with at least 15 years of industry experience responsible and experienced in manufacturing and supply chain management in a CDMO, pharmaceutical or related environment or equivalent experience and/or education
- Technical knowledge and hands-on experience in GMP manufacturing of immune cell therapy technologies, gene editing and gene therapy technologies
- Experience with late-stage product development and successful transition to clinical and commercial and product launch
- Experience in GMP facility design and construction, equipment selection, qualification and validation
- Experience in large-scale manufacturing operations with GMP requirements
- Experience in CMC regulatory affairs for US FDA, NMPA and EMA is a plus
- Direct management experience with successful track record of building, coaching and mentoring a high-performing team
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Able to work in a matrixed, fast-paced and dynamic environment with competing priorities and prioritize driving projects forward and meeting program/project deliverables
- Knowledge of cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements
- Performs other tasks and assignments as needed and specified by management
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