QC Specialist: Analytical Method Validation and Transfer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Join Us as a QC Specialist - Make an Impact at the Forefront of Innovation

This position will be responsible for the overall strategy and authoring and review/adjudication of validation and transfer protocols and reports. This role will partner closely with Quality Assurance (QA), Analytical Development, and various QC functions to support clinical and commercial biologics QC readiness.

The successful candidate will preferably have strong experience in GMP documentation, biologics analytical methods, and method validation and transfer.

What You'll Do:

• Lead the validation, qualification, verification, and lifecycle management of analytical methods supporting biologic drug substance and drug product testing.

• Serve as the technical lead for analytical method transfers to internal laboratories, contract testing laboratories (CTLs), and regulatory affiliates, ensuring successful demonstration of method equivalency and readiness for routine testing.

• Author and review method transfer plans, protocols, gap assessments, risk assessments, statistical evaluations, and final transfer reports.

• Provide technical expertise, training, troubleshooting, and hands-on support during method validation and transfer activities to ensure successful implementation at receiving laboratories.

• Collaborate with Analytical Development, Quality Assurance, Regulatory Affairs, and external partners to support product development, commercialization, and post-approval lifecycle activities.

• Ensure analytical methods, specifications, reagents, standards, and testing procedures are compliant with applicable GMP, health authority, and regional regulatory requirements.

• Investigate method transfer failures, atypical results, deviations, OOS/OOT events, and analytical discrepancies, implementing effective corrective and preventive actions as needed.

Education & Experience Requirements:

• Bachelor's degree or equivalent in Biochemistry, Biology, Biotechnology, Microbiology, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Qualifications:

• Demonstrated experience leading analytical method validation, qualification, verification, and transfer activities for biologic drug substance and drug product programs.

• Experience authoring and reviewing validation and transfer protocols, reports, technical assessments, and GMP documentation.

• Experience supporting global testing networks, including contract testing laboratories (CTLs), CDMOs, and in-country testing laboratories.

Preferred Qualifications:

• Strong understanding of cGMP, ICH, USP, EP, JP, and applicable global regulatory requirements governing analytical testing and method validation.

• Hands-on experience with biologics analytical techniques such as HPLC/UPLC, CE-SDS, icIEF, ELISA, and cell-based potency assays.

• Strong knowledge of analytical method validation principles, statistical analysis, comparability assessments, and method transfer strategies.

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

• Occasional drives to site locations with occasional travel both domestic and international.

• Long, varied hours required occasionally

• Interaction with clients/associates on rare occasions

• Rotating shifts required on rare occasions where applicable

• Exposure to toxic materials on rare occasions.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

Compensation and Benefits

The salary range estimated for this position based in California is $91,000.00–$101,001.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.