New · posted Nov 12
Thermo Fisher Scientific · Biotechnology
QC Specialist: Analytical Method Validation and Transfer
- Foster City, CA
- On-site
- Full-time
- Senior & Principal
The role
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.
What you need
Preferred Qualificationsnice to have
• 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.
Pay and benefits
$91,000 – $101,001 a year
Employer providedThe 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
Medical, dental and vision plans
401(k) retirement plan
Paid time off and 10 paid holidays
Paid parental leave
Employee Stock Purchase Plan
Tuition reimbursement
Where you'll work
Foster City, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Foster City, CASchedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% below the US median for Quality Control roles at this level.
This roleEmployer provided
Senior & Principal roles in California5 roles publishing pay
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $91,000 | — | $101,001 |
| California (middle half) | $123,000 | $126,000 | $174,000 |
| All US (middle half) | $89,000 | $97,500 | $110,000 |
This role: Thermo Fisher Scientific's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 264 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 17 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods14
- Validation and qualification10
- Collaboration and leadership7
- Documentation and SOPs5
- GMP and compliance4
- Clinical trial conduct3
- Investigations and CAPA1
- Regulatory submissions1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Control work in biotechnology, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validationNamed in the posting
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical ProductionNamed in the posting
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- ICHICH Q5 and Q6B(official source, opens in a new tab)Quality of biotechnological products and their specifications
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 114
- Open roles
- 114
- Distinct roles
- 52
- Locations
By discipline
- Quality76 64%
- Clinical37 31%
- Regulatory6 5%
By level
- Senior & Principal60 50%
- Associate & Specialist28 24%
- Manager25 21%
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QC Specialist: Analytical Method Validation and Transfer at Thermo Fisher
Open until filled. $91K–$101K a year, employer provided.