Analytical Validation Specialist

Location: San Diego, 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.