Senior Specialist II, Quality Control Validation

ElevateBio; Waltham (MA); On-site; USD 150,000 - 200,000; Full time

Job summary

ElevateBio is seeking a Senior Specialist II in QC Validation to lead validation activities for cell and gene therapy programs at our Waltham manufacturing facility. You will design validation plans, execute experiments, and analyze data to ensure regulatory readiness and quality. Collaboration with Analytical Development, QC, and QA is essential to meet timelines.

Requirements include B.S. or M.S. in a related field with GMP QC lab experience and demonstrated expertise in gene/cell therapy

Qualifications

• Bachelor's or Master’s degree with GMP QC lab experience and experience in cell/gene therapy testing.
• Experience with validation planning and execution for commercial manufacturing.
• Proficient in data analysis and regulatory compliance.

Responsibilities

• Define validation strategy, plan, and protocol based on regulatory requirements and standards.
• Collaborate with Analytical Development and QC testing to align data and timelines.
• Analyze data and report validation results.
• Ensure methods, equipment, and SOPs are suitable for validation in manufacturing.
• Oversee change controls and support inspections/audits.
• Hire, train, and mentor staff as needed.

Skills

GMP QC laboratory experience

Data analysis

Communication

Organizational skills

Independent work

Education

B.S. in Biology/Molecular Biology/Chemistry or related field

M.S. in similar discipline

Tools

LIMS

CMMS

QMS

ERP

Job description

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

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.

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.