Analytical Validation Specialist
Location: Torrance, CA | Employment Type: Full-Time
Why This Role Matters
At PolyPeptide, analytical validation is central to how we deliver safe, reliable peptide APIs to customers worldwide. As an Analytical Validation Specialist, you will own and execute critical method validation, verification, and transfer activities that directly support development programs, GMP manufacturing, and regulatory readiness.
This role offers meaningful technical ownership, regular cross-functional collaboration, and exposure to customer and regulatory interactions. If you enjoy applying analytical science in a highly regulated environment and want your work to have real-world impact, this role provides both challenge and visibility.
What You’ll Do
You’ll serve as a subject matter expert for analytical validation, ensuring methods are scientifically sound, compliant, and ready to support manufacturing and regulatory needs.
Analytical Validation & Lifecycle Management
Plan, execute, and document analytical method validation, verification, and transfer activities in alignment with ICH, FDA, EMA, and internal SOPs
Draft, review, and approve validation protocols, technical reports, and supporting documentation
Support analytical method lifecycle management and continuous improvement initiatives
Cross-Functional Collaboration
Partner closely with Analytical Development, Quality Control, Regulatory Affairs, Quality Assurance, and Project Management teams
Ensure validation activities are completed on time and aligned with project timelines and customer commitments
Participate in customer meetings, audits, and regulatory inspections as the analytical validation subject matter expert
Data Analysis & Problem Solving
Perform data analysis and interpretation using appropriate statistical tools to support validation conclusions
Investigate and troubleshoot analytical methods or instrumentation issues
Support deviation investigations related to validation studies, including root cause analysis and CAPA development
Training & Knowledge Sharing
Support training, competency assessments, and performance development of laboratory personnel as appropriate
Promote best practices in Good Documentation Practices (GDP) and cGMP compliance
What We’re Looking For
Education
Bachelor’s, Master’s, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline
Experience
3+ years of hands-on experience in analytical method validation within a pharmaceutical or CDMO environment
Skills That Will Help You Succeed
Technical Expertise
Strong working knowledge of ICH Q2 and applicable global regulatory guidelines
Hands-on experience with analytical techniques including HPLC, LC-MS, GC, UV, Karl Fischer, and related instrumentation
Proficiency in statistical analysis, data interpretation, and technical report writing
Experience with peptides and/or oligonucleotides is strongly preferred
Professional Strengths
Excellent organizational, communication, and documentation skills
Ability to manage multiple priorities and adapt quickly in a fast-paced environment
Strong collaboration skills across departments and functional boundaries
Comfortable working independently while contributing effectively within a team
How Success Is Measured
On-Time Delivery: Validation projects completed within agreed timelines
Compliance: High adherence to cGMP and regulatory requirements with minimal audit findings
Documentation Quality: Accurate, complete, and audit-ready validation documentation
Work Environment
Primary work setting is a laboratory environment requiring appropriate PPE
Ability to stand for extended periods and handle light-to-moderate laboratory equipment in accordance with safety guidelines
About PolyPeptide
PolyPeptide is a global leader in peptide-based active pharmaceutical ingredients, partnering with innovators worldwide to deliver high-quality, reliable solutions that support life-changing therapies. Our teams are driven by science, collaboration, and a shared commitment to excellence.
At PolyPeptide, you’ll work alongside experts who value rigor, integrity, and continuous improvement, while building a career that makes a tangible impact on patient outcomes.
If you’re ready to apply your analytical expertise in an environment where quality truly matters, we’d love to hear from you.
Salary: $80k-$90k per year
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.