• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule:
• Building:
• Salary Range: $88,400 - $115,000

Position Summary

The Columbia Initiative in Cell Engineering and Therapy (CICET) Senior Quality Control (QC) and Analytics Specialist will report to the Associate Director of the CICET Quality Control and Analytics and collaborate with the CICET Process Development (PD)/GMP Manufacturing and research (discovery) teams to develop robust analytical assays required for characterization and perform QC testing of drug substances and clinical-grade drug products, supporting the timely release of cost-effective, GMP compliant, and high-quality cell/ gene therapy products.

Responsibilities

The Senior QC and Analytics specialist will support the set-up and opening of the CICET QC and Analytics laboratory, responsible for the day-to-day laboratory operations and maintenance, assist in the drafting and approval of the Analytics and QC Standard Operating Procedures (SOPs), perform internal Analytical assays and QC testing required for drug product release, characterization, and stability throughout the product development lifecycle, help identify and manage contract testing laboratories (CTL) for assay development and testing, and collaborate with the PD/GMP and Facility Operations teams.

Analytical Method Development and Validation

• Assist in developing, qualifying, and validating analytical methods for cell and gene therapy products
• Perform internal analytical assays during process development to monitor process (scale-up) and method development
• Help identify and manage CTLs to ensure timely turnaround time from sample submission to reporting of assay results
• Collaborate with the research and process development teams to transfer biological and molecular assays needed for the development of characterization and release assays and assist in troubleshooting assays
• Support continuous improvement of QC workflows to enhance efficiency and assay robustness

Quality Control and Compliance

• Conduct internal QC testing and analytics for cell therapy products, including in-process, release, and stability testing
• Perform QC assay qualification and validation
• Ensure compliance with cGMP regulations, safety protocols, and internal quality standards
• Assist in Out-of-Specification (OOS), deviations, and corrective and preventive actions (CAPA) investigations

Documentation and Audit Management

• Support the drafting, reviewing, and amending SOPs, specifications, regulatory filings, or other controlled documents in collaboration with QA team
• Support regulatory filings and audits by preparing necessary documentation and presenting findings
• Assist in all regulatory and internal audits of the facility
• Assist in internal and external regulatory audits and inspections as required
• Ensure data are promptly captured and recorded according to Good Documentation Practices (GDP) to ensure data integrity and compliance with health agencies' regulations

Additional Responsibilities

• Collaborate with cross-functional teams, including Process Development, Quality Assurance, and Manufacturing, to optimize QC systems
• Maintains the Analytics and QC laboratory to ensure efficient day-to-day operations
• Assists in training and onboarding Analytics and QC technicians

Minimum Qualifications

• Minimum of 4 years of related experience in laboratory facilities and operations management in an academic environment
• Bachelor's degree in Biology, Chemistry, or related field, or equivalent in education and experience
• Ability to work independently to complete tasks and collaboratively with multiple teams to execute CICET strategic activities
• Experience with Analytical development and QC testing of cell and gene therapy products
• At least 4 years of relevant scientific experience in cell/gene and GMP-regulated environment
• Strong analytical and problem-solving skills with a detail-oriented approach
• Excellent organizational skills and ability to manage multiple priorities
• Strong interpersonal and communication skills (written/ verbal)
• Working knowledge of computer programs, such as Microsoft Outlook, Word, Excel, PowerPoint, SharePoint, Teams, Adobe Acrobat, Zoom, and data analysis software
• Ability to set priorities and exercise sound judgment and initiative
• Must possess the ability to handle multiple projects simultaneously and prioritize tasks while maintaining responsibility for timely execution
• Strong customer service orientation and skills, with the ability to interact and collaborate positively, constructively, and effectively with multiple stakeholders

Preferred Qualifications

• Strongly prefer at least 6 years of relevant scientific experience in cell/gene and GMP-regulated environment
• Prefer master's degree in a relevant scientific discipline or certification in data analytics or related data analysis education, including statistics
• Basic knowledge of environmental monitoring practices and clean room operations
• Certification in Quality Management Systems (e.g., CQM, CQA)

Other Requirements