MEDSTAR HEALTH
Scroll down to find the complete details of the job offer, including experience required and associated duties and tasks.
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.
#J-18808-Ljbffr
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.
#J-18808-Ljbffr