Analytical Validation Specialist - San Diego
About The Position
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.
Requirements
- Bachelor’s, Master’s, or PhD in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline
- 3+ years of hands-on experience in analytical method validation within a pharmaceutical or CDMO environment
- 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
- 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
Nice To Haves
- Experience with peptides and/or oligonucleotides is strongly preferred
Responsibilities
- 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
- 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
- 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
- Support training, competency assessments, and performance development of laboratory personnel as appropriate
- Promote best practices in Good Documentation Practices (GDP) and cGMP compliance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
1,001-5,000 employees
