The Role

The Senior Specialist II, QC Validation role l is responsible for overseeing method validation and overall validation readiness within Quality Control at our Manufacturing facility. In this role, you’ll be responsible for developing validation plans/protocols, executing/organizing validation activities, analyzing data, documenting results, and maintaining compliance with regulatory standards for our cell and gene therapy programs transitioning from early clinical phase. In addition, this position will work closely with the Analytical Development, QC management, QC testing, and QA teams, as well as customers to ensure that validation objectives are met.

Here’s What You’ll Do

• Define the validation strategy, plan, and protocol for applicable methods based on regulatory requirements and industry standards, as well as client requirements.
• Collaborate with Analytical Development to ensure validation is consistent with, and utilizes, initial development, qualification, and method performance data.
• Collaborate with QC testing functions (i.e. QC Microbiology, QC Raw Materials and QC Outsourcing) to ensure all testing is initiated and completed within established timelines.
• Analyze associated data and report validation results.
• Ensure test methods, associated equipment/software, and associated SOPs are appropriate for validation in preparation for commercial manufacturing. Collaborate on and oversee change controls, as needed.
• Support inspections and facility audits.
• Hire, train, and mentor supporting staff, as needed.

Requirements

• B.S. in a technical discipline (Biology/Molecular Biology/Chemistry or related field) with a minimum of 8 years of experience in GMP QC laboratory setting, or M.S. in a similar discipline with a minimum of 6 years of experience.
• Expertise with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
• Ability to communicate and work independently with scientific/technical personnel.
• Strong knowledge of GMPs, SOPs, and Quality system processes.
• Strong data analysis skills.
• Excellent organizational skills.
• Experience with method validations for commercial products.
• Experience in cell and gene therapy manufacturing environment is a plus.
• Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.

Physical and Environment Requirements:

• Ability to stand, walk, bend and stretch for extended period of time
• Ability to perform routine repetitive motions with use of arms, wrists and hands

The budgeted range for this position is $150,000 - $200,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.