Senior Specialist II, Quality Control Validation

Scorpion Therapeutics; Waltham (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Specialist II, QC Validation, to oversee method validation and validation readiness within Quality Control for cell and gene therapy manufacturing. The role focuses on developing validation strategies, executing activities, and ensuring regulatory compliance across QC operations.

The ideal candidate will have 8+ years (BS) or 6+ years (MS) in GMP QC, with expertise in gene and cell therapy assays, and strong data analysis and quality system knowledge.

Qualifications

• BS or MS with GMP QC experience (8+ years with BS, 6+ years with MS)
• Experience with gene and cell therapy assays (qPCR, ddPCR, flow cytometry, ELISA, cell-based assays)
• Strong GMP, SOP, and quality system knowledge
• Data analysis skills
• Experience with method validation for commercial products

Responsibilities

• Develop validation strategies, protocols, and plans aligned with regulatory standards.
• Execute validation activities and document results.
• Analyze data and prepare technical reports.
• Ensure compliance with GMP and regulatory requirements.
• Collaborate with Analytical Development, QC testing, QA, and customer teams.
• Support inspections and audits; mentor supporting staff.

Skills

qPCR

ddPCR

Flow cytometry

ELISA

Cell-based assays

Data analysis

GMP knowledge

SOP knowledge

Quality systems

Education

BS in Biology / Molecular Biology / Chemistry or related field

MS in Biology / Molecular Biology / Chemistry or related field

Tools

LIMS

QMS

Job description

Role: Senior Specialist II, QC Validation, overseeing method validation and validation readiness within Quality Control for cell and gene therapy manufacturing.

Responsibilities

• develop validation strategies, protocols, and plans aligned with regulatory standards
• execute validation activities
• analyze data
• ensure compliance
• collaborate with Analytical Development, QC testing, QA, and customer teams
• support inspections and audits
• mentor supporting staff

Qualifications

• BS in Biology, Molecular Biology, Chemistry, or related field with 8+ years (or MS with 6+ years) in GMP QC
• expertise in gene and cell therapy assays like qPCR, ddPCR, flow cytometry, ELISA, cell-based assays
• strong GMP, SOP, and quality system knowledge
• data analysis skills
• experience with method validation for commercial products
• preferred experience in cell/gene therapy manufacturing and electronic systems (LIMS, QMS)

HighValue

• cell and gene therapy
• validation
• GMP QC
• microbiology
• raw materials
• outsourcing
• regulatory compliance

WorkSetup: not specified; physical requirements include standing and routine movements.