PolyPeptide Group · 1 day ago
Analytical Validation Specialist - San Diego
San Diego, CA
Full-time
Onsite
Mid Level
$80K/yr - $90K/yr
3+ years expPolyPeptide Group is a global leader in peptide-based active pharmaceutical ingredients. As an Analytical Validation Specialist, you will own and execute critical method validation, verification, and transfer activities that support development programs and regulatory readiness.
Manufacturing
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
Qualification
Required
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
Preferred
Experience with peptides and/or oligonucleotides is strongly preferred
Company
PolyPeptide Group
The PolyPeptide Group is a contract manufacturing organization for peptides and peptide related molecules.
1001-5000 employees
H1B Sponsorship
PolyPeptide Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (2)
Funding
Current Stage
Public CompanyTotal Funding
$161.81M2025-05-23Post Ipo Debt· $45.48M
2023-10-02Post Ipo Debt· $116.33M
2021-04-29IPO
Leadership Team
Juan Jose Gonzalez
Chief Executive Officer
El Djouhar RekaÏ
Head of Business Unit Peptide Process Development & Manufacturing
Recent News
2026-01-19
MarketScreener
2025-12-12
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