US Site Head

4 weeks ago

Rapid City, South Dakota, United States GenScript Full time

About GenScript

GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.

GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology

About GenScript ProBio

GenScript ProBio is the subsidiary of GenScript Biotech Corporation, proactively providing end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy (CGT), vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. GenScript ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing. In terms of plasmid service, GenScript ProBio supports the most clinical approvals for CGT drugs including mRNA vaccines, CAR-T in China. It is also the first GMP manufacturing platform to provide in vitro transcription (IVT) template linearized plasmids for mRNA vaccines and has supported several mRNA vaccine global enterprises to obtain clinical approvals. In terms of viral vector service, GenScript ProBio has a stable and high-yield viral vector platform.

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

      GenScript USA Inc/GenScript ProBio USA Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.
      GenScript USA Inc./GenScript ProBio USA Inc. maintains a drug-free workplace.

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