Director,CICET Core Facilities

Columbia University; New York (NY); On-site; USD 175,000 - 200,000; Full time

Job summary

An established industry player seeks a Director for its Cell Engineering and Therapy Core Facilities. This pivotal role involves leading cell and vector production activities, ensuring compliance with regulatory standards, and fostering partnerships with academic and clinical collaborators. The successful candidate will align the core's mission with strategic institutional goals while managing a talented team. This position offers an exciting opportunity to contribute to groundbreaking advancements in cell therapy and immuno-oncology, making a significant impact in the field. Join a dynamic environment where innovation thrives and your expertise will shape the future of therapeutic solutions.

Qualifications

• Minimum of 5 years of experience in GMP environment.
• Expertise in clinical cell therapy and regulatory submissions.

Responsibilities

• Oversee cell and vector production activities in a cGMP facility.
• Ensure compliance with regulatory and accrediting bodies.

Skills

Excellent verbal and written communication skills

Demonstrated executive and leadership abilities

Excellent organizational skills

Ability to set priorities and exercise sound judgment

Capability to handle multiple projects simultaneously

Education

Bachelor's degree or equivalent

MD or PhD in a relevant discipline

Tools

Microsoft Outlook

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

SharePoint

Teams

Adobe Acrobat

Zoom

Job description

• Job Type: Officer of Administration


• Bargaining Unit:


• Regular/Temporary: Regular


• End Date if Temporary:


• Hours Per Week: 35


• Standard Work Schedule:


• Building:


• Salary Range: $175,000 - $200,000

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Director of the Cell Engineering and Therapy Core Facilities will be responsible for developing, directing, and overseeing cell and vector production activities in the newly established cGMP facility within the Columbia Initiative in Cell Engineering and Therapy (CICET). The Director will also be responsible for coordinating with the Medical Director and Clinical Operations, ancillary facilities, external collaborators and other supply chain vendors.

The Director will ultimately provide oversight and leadership to the core personnel for cell and vector manufacturing , facilities operations, and quality control, and coordinate closely with the CTO (IND applications), Regulatory Affairs and Quality Assurance groups.

The Director is expected to align the core's mission with the institutional strategic planning and will report to the Director of Columbia Initiative in Cell Engineering and Therapy.

Responsibilities

Strategic and Leadership Responsibilities

• Set short, medium, and long-term technical directions for the facilities, aligning with the strategic vision of CICET leadership.


• Align the core's mission and activities with institutional strategic planning and report to the Director of Columbia Initiative in Cell Engineering and Therapy.


• Actively identify new scientific/technical opportunities and provide strategic and scientific guidance in technical areas.

Operational and Technical Responsibilities

• Oversee SOP development to support clinical trials approved by CICET leadership.


• Provide oversight of advanced methods development, scientific consultation, and liaising with the scientific community to maintain a state-of-the-art operation.


• Ensure adequate staffing for analytical development in biological assays, cellular characterization, and functional assay method development.

Regulatory and Compliance Management

• Ensure compliance with regulatory and accrediting bodies (e.g. FDA, FACT).


• Guide the preparation of technical documents and regulatory submissions, and contribute to development of CMC strategies for compliance with US and international standards.

Financial and Human Resource Management

• Handle financial management and human resource management of the facility, including hiring, training, mentoring, and staff career development.

Partnerships and External Collaborations

• Promote partnerships with internal academic investigators, external sponsors, and stakeholders within NYP and Weill Cornell Medicine to support cell therapy discovery and development.

Additional Roles

• Assist in production and support of complex cell manufacturing, including genetically modified cells for clinical trials.


• Participate in external scientific and professional committees in cellular therapeutics to advance program reputation.

Minimum Qualifications

Educational and Professional Requirements

• Bachelor's degree or equivalent in education and experience


• Minimum of 5 years of experience in academic or industrial GMP environment

Technical Expertise

• Expertise in investigational and clinical cell therapy, including development of cellular immuno-oncology therapies or gene therapies, and regulatory submissions


• Extensive knowledge of cGMP cell manufacturing, with the ability to develop, validate, and transfer new findings into facility manufacturing processes and product testing

Skills and Abilities

• Excellent verbal and written communication skills


• Demonstrated executive and leadership abilities


• Excellent organizational skills and ability to manage multiple priorities


• Ability to set priorities and exercise sound judgment and initiative


• Capability to handle multiple projects simultaneously and ensure timely execution

Technical Proficiency

• Working knowledge of computer programs such as Microsoft Outlook, Word, Excel, PowerPoint, SharePoint, Teams, Adobe Acrobat, and Zoom


• Interpersonal and Customer Service Skills


• Strong customer service orientation and skills


• Ability to interact and collaborate positively, constructively, and effectively with multiple constituencies

Preferred Qualifications

• Strongly prefer MD or PhD in Biochemistry, Cell Biology, Molecular Biology, Virology, Immunology, Biological Sciences, Cell Therapy or Gene Therapy, or a related discipline


• Strongly prefer 10+ years of experience in academic or industrial GMP environment


• Previous experience in managing a large core facility in a multi-user environment

Other Requirements

• Successful completion of applicable compliance and systems training requirements

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.