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; 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
REQUIREMENTS:
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 ultimate goal of providing life changing treatments at the Point of Care to large numbers of patients at low cost.
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