Active Pharmaceutical Ingredient (API), Analysis Skills, Analytical Chemistry, Analytical Development, Analytical Method Validation, Application Programming Interface (API), Biotech and Pharmaceutical, Channel Strategies, Communication Skills, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Analysis, Documentation, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), High Performance Liquid Chromatography (HPLC), ICH Regulations, Identify Issues, Instrumentation, Laboratory Equipment, Liquid Chromatography-Mass Spectrometry (LC-MS), Manufacturing Requirements, Multitasking, Organizational Skills, Pharmaceutical Analysis, Problem Solving Skills, Project/Program Management, Quality Assurance, Quality Control, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Root Cause Analysis, Staff Development, Standard Operating Procedures (SOP), Statistics, Team Player, Technical Support, Technical Writing, Time Management, Validation Documentation, Validation Plan, Validation Testing
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 Youll Do
Youll 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 Were Looking For
Education
- Bachelors, Masters, 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, youll work alongside experts who value rigor, integrity, and continuous improvement, while building a career that makes a tangible impact on patient outcomes.
If youre ready to apply your analytical expertise in an environment where quality truly matters, wed 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.