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US Site Head

3 months ago

Pennington, United States ProBio Inc Full time

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:


  1. Oversee GMP manufacturing facility consisting of design, construction, validation of facility, and supply chain system and operations.
  2. Oversee the preparation and management of complex GMP manufacturing facility development plans, budgets, and long-range planning
  3. Oversee full-scale operations in a multi-product GMP facility, manage and control production schedule
  4. Collaborate with Quality and PD/MSAT teams to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections
  5. Works with C-level executives to set annual strategic initiatives and ensure alignment with company goals
  6. 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
  7. Perform other duties as assigned based on business needs


Qualifications:


  1. 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
  2. Technical knowledge and hands-on experience in GMP manufacturing of immune cell therapy technologies, gene editing and gene therapy technologies
  3. Experience with late-stage product development and successful transition to clinical and commercial and product launch
  4. Experience in GMP facility design and construction, equipment selection, qualification and validation
  5. Experience in large-scale manufacturing operations with GMP requirements
  6. Experience in CMC regulatory affairs for US FDA, NMPA and EMA is a plus
  7. Direct management experience with successful track record of building, coaching and mentoring a high-performing team
  8. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
  9. Able to work in a matrixed, fast-paced and dynamic environment with competing priorities and prioritize driving projects forward and meeting program/project deliverables
  10. Knowledge of cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements
  11. Performs other tasks and assignments as needed and specified by management