QC Scientist - Analytical Method Development

YOH Services LLC; Lexington (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading company in the life sciences sector is seeking a QC Scientist specializing in Analytical Method Validation. This role involves collaborating with various teams to validate analytical procedures for gene therapy products. The ideal candidate will have extensive experience in a GLP/cGMP environment and strong analytical skills.

Qualifications

• Minimum 6 years of analytical laboratory experience in GLP/cGMP environment.
• Experience with analytical method validations and data trending.
• Strong technical writing skills for protocols and reports.

Responsibilities

• Optimize, qualify, transfer, and validate analytical methods.
• Write protocols and reports related to method transfer and validation.
• Perform statistical data analysis and monitor analytical method performance.

Skills

Analytical method validation

Data trending

Statistical analysis

Technical writing

Quality systems requirements

Tools

MS Word

Excel

JMP

Minitab

LIMS

Job description

QC Scientist - Analytical Method Development

Category: Life Science

Employment Type: Contract To Hire

Reference: BH-385405

Job Details

Position: QC Scientist - Analytical Method Validation

Location: Lexington, MA - 100% Onsite

Pay rate: $45 - $55 per hour depending on experience

Minimum Experience Requirements

• Minimum 6 years of analytical laboratory experience in GLP/cGMP environment, ideally with analytical method validation and transfer.

Preferred Skills and Experience

• Experience with analytical method validations, data trending, and statistical analysis.
• Understanding of QC instrument qualification preferred.
• Knowledge of industry testing standards and requirements for gene/cell therapy products.
• Experience with cell-based bioassays using mammalian cell lines and QC instrument qualification.
• Familiarity with ICH, FDA, and EMA guidance documents related to gene/cell therapy.
• Proficiency in quality systems requirements.

Skills / Abilities

• Proficiency in MS Word, Excel, JMP, Minitab, LIMS, etc.
• Ability to adapt in a fast-changing environment and work collaboratively.
• Strong technical writing skills for protocols, reports, and procedures.

Job Summary

The QC Scientist in Analytical Method Validation plays a key role within our Quality Control Technical Services (QCTS). This individual will collaborate with analytical development, quality control, and quality assurance teams to transfer and validate analytical procedures for viral vectors, cell banks, and gene therapy products.

Essential Job Functions

• Optimize, qualify, transfer, and validate analytical methods under guidance from QC Manager.
• Write protocols and reports related to method transfer, qualification, feasibility, and validation.
• Perform statistical data analysis and support monitoring of analytical method performance.
• Assist with data trending, documentation, and investigations related to cGMP operations.
• Present findings to cross-functional teams and communicate analytical issues effectively.
• Provide expertise in product quality attribute methods relevant to gene therapeutics and viral vectors.
• Maintain current procedures, troubleshoot equipment, and train other QC analysts.

Note: Pay ranges are estimates; actual pay depends on experience and qualifications. Yoh is an Equal Opportunity Employer. For accommodations, visit Yoh Disabilities Page. California applicants will be considered under local laws regarding criminal records.