Site Head

OVERVIEW:
 Job Title: Site Head of Cell Therapy cGMP OperationsReports to: Head of US Operations and/or CEODepartment: OperationsDirect Reports: 1-2Location: Folsom, CaliforniaFLSA Category: Full-Time; Non-Exempt Compensation/Salary: D.O.E.   
DUTIES/RESPONSIBILITIES:

• Support the design, build and startup of cGMP manufacturing of cell therapy products.
• Oversee the establishment of the Manufacturing, QC, Warehouse, QA, Maintenance and Validation departments, including the procurement and installation of equipment and the hiring process of personnel for these departments.
• Oversee the overall activities of the site and lead flexible and efficient operation and ensure safe and reliable supply of products.
• Recruit, retain, and develop high-performing and diverse teams.
• Ensure safety, quality, compliance, efficiency and sustainability throughout the site operations activities.
• Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget.
• Build collaborative and empowered teams that put patients first.
• Establish and maintain strong relationships at the site and cross functionally.
• Ensure Tech Transfer activities to this site are perform on time and fully completed per the company Tech Transfer policy prior to cGMP manufacturing.
• Identify and mitigate risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients.

• Minimum seven years of relevant experience.
• Bachelor's degree in a life scientific discipline or related field is required; an advanced degree (e.g., Master's, Ph.D.) is highly desirable.  
• Proven experience as a direct manager of people and as a leader in a cGMP Manufacturing operations of cell therapy products with clear understanding of the required relationships between Manufacturing and the other supporting departments (i.e. Warehouse, Maintenance, QC, QA etc.).
• Outstanding written and verbal communication skills.
• Ability to manage multiple projects and priorities and adapt quickly to changing circumstances.
• Ability to drive the teams to evaluate challenges during Tech Transfer and routine operations and provide resolutions in a timely manner.
• Strong leadership qualities, with a demonstrated track record of building high performance teams with strong cross-functional relationships.
• Excellent problem-solving and decision-making skills, with the ability to navigate complex issues.
• Effective communication (both oral and written) and interpersonal skills, with the ability to interact with stakeholders at all levels of the organization.  
• Proactive, results-oriented mindset with a demonstrated ability to drive change and deliver high-quality results within established timelines.  
• Ability to work under pressure and constantly adjust to the demands of various projects.
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Fluency in English; additional language skills would be a plus.    

INTERESTED?:  
If you are interested in this position, please click apply! We offer a competitive salary, benefits package, and a dynamic work environment with opportunities for growth and advancement. Please note that although we appreciate your interest, only qualified candidates will be contacted.   

ABOUT US:  
Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell and Gene Therapy Biotech Platforms, with the goal of providing life changing treatments at the Point of Care to large numbers of patients at low cost. At Orgenesis, we aim to improve the accessibility and affordability of cell and gene therapies by providing innovative solutions, such as our OMPUL (Orgenesis Mobile Processing Unit and Labs) platform. Our Point of Care Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of life-saving therapies.

 

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