QC Scientist - Analytical Method Development

Yoh Services LLC; Lexington (KY); 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 Development. This role involves validating methodologies for testing viral vectors and gene therapy products while ensuring compliance with cGMP standards. Candidates should bring a strong analytical background with proven experience in quality control settings, engaging in collaborative, fast-paced environments.

Qualifications

• Minimum 6 years of analytical laboratory experience in GLP/cGMP environment.
• Preferred experience with cell-based bioassays.
• Understanding of QC instrument qualification is preferred.

Responsibilities

• Optimize, qualify, transfer, and validate analytical methods.
• Write protocols and reports related to QC Method transfer.
• Perform statistical analyses during method validation.

Skills

Analytical method validation

Analytical data trending

Statistical analysis

Technical writing

Collaboration

Education

6+ years of analytical laboratory experience

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

QC Scientist – Analytical Method Validation
Lexington, MA – 100% Onsite
Contract to Hire
Pay rate: $45 - $55 per hour depending on experience

**** Minimum 6 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer.
OTHER EXPERIENCE:

• Prior experience with analytical method validations, analytical data trending/statistical analysis
• Understanding of QC instrument qualification is preferred.
• Thorough understanding of industry testing requirements/standards
• Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential.
• Thorough understanding of industry testing requirements/standards related to gene/cell therapy products.
• Familiar with ICH, FDA and EMA guidance documents relevant to gene/cell therapy
• Working knowledge of quality systems requirements

QC Scientist – Analytical Method Validation
Lexington, MA – 100% Onsite
Contract to Hire
Pay rate: $45 - $55 per hour depending on experience

**** Minimum 6 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer.
OTHER EXPERIENCE:

• Prior experience with analytical method validations, analytical data trending/statistical analysis

• Understanding of QC instrument qualification is preferred.

• Thorough understanding of industry testing requirements/standards

• Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential.

• Thorough understanding of industry testing requirements/standards related to gene/cell therapy products.

• Familiar with ICH, FDA and EMA guidance documents relevant to gene/cell therapy

• Working knowledge of quality systems requirements

SKILLS / ABILITIES

• Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.)

• Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential

• Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities

• Proven demonstration of technical writing skills such as protocol, reports, procedures etc.

JOB SUMMARY:The QC Scientist Analytical Method Validation is key role within our Quality Control Technical Services (QCTS) department. The individual in this role will work collaboratively with the analytical development team, quality control, and quality assurance to transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products.
ESSENTIAL JOB FUNCTIONS

• Works under guidance of QC Manger responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production
• Writes protocols and reports related to QC Method transfer, qualification, feasibility and validation
• May assist in writing protocols or participate in instrument qualifications
• Perform statistical analyses of data generated during method validation studies, qualification and critical material qualification
• Support monitoring of analytical method performance, including assessmentof analytical method system suitability requirements
• Assist with data trending and aid in compilation of trend reports
• Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting
• Present to cross-functional teams and effectively communicate critical analytical issues and solutions
• Subject matter expertise in product quality attribute methods relevant to gene therapeutic product (e.g. cell function characterization assays, HPLC, PCR / qPCR, ELISA, Potency Assay, SDS-PAGE and western blot) and/or viral vector manufacturing
• Familiar with FDA and EMA guidance documents relevant to gene therapy
• Working knowledge of quality systems requirements
• Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities
• Demonstrated leadership skills and the ability to collaborate with and effectively influence others
• Establish, revise, review and maintain procedures (including protocol and technical report)
• Assure that laboratory procedures are current and facilitate updates as required
• As applicable perform routine/non-routine testing of in-process, final product in accordance with Standard Operating Procedures (e.g., Q-PCR, Potency Assay, Western Blot, Refractometry, ELISA, etc.) as needed
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP)
• Maintain QC lab and related systems to ensure compliance with industry standards
• Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency
• Troubleshoot equipment and analytical testing methods
• Training of other QC Analysts within the department

Estimated Min Rate: $45.00
Estimated Max Rate: $55.00


Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilitiesto contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship, potentially resulting in the withdrawal of a conditional offer of employment.

Posted on 05-16-2025

QC Scientist - Analytical Method Development