Sinopep Jiangsu Inc.
Senior Scientist, Peptide Analysis
Sinopep Jiangsu Inc., San Diego, California, United States, 92189
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Senior Scientist, Peptide Analysis (Ph.D.) About Us Sinopepi s a leading China-based CDMO partner focused on accelerating the discovery, development, and manufacturing of innovative Peptide and oligonucleotide therapeutics. We provide integrated solutions from preclinical to commercial supply, leveraging state-of-the-art facilities and deep scientific expertise. Join our dynamic team and contribute to advancing the next generation of genetic medicines for global partners. Position Summary We are seeking a highly skilled and innovative Ph.D. Scientist to join our Analytical Development team as a Senior Scientist, Peptide Analysis. This role is central to designing and executing advanced analytical strategies for the characterization and quality control of peptide-based drug substances and products. The ideal candidate is a hands-on expert in peptide analysis, with a deep theoretical and practical understanding of modern chromatographic and spectroscopic techniques. You will be a key technical contributor, driving quality research for client projects from early-stage development through to regulatory submissions. Key Responsibilities Independently design, develop, optimize, and validate robust, stability-indicating analytical methods for peptides (e.g., U/HPLC-UV/MS, CE, LC-MS/MS for identity, purity, impurities, and assay). Lead method transfer activities to the QC team or to client sites. Perform comprehensive characterization of synthetic peptides, including primary structure confirmation by LC-MS/MS, peptide mapping, and the identification and quantification of process-related impurities and degradation products. Serve as a subject matter expert (SME) in peptide analysis for internal teams and external clients. Lead root cause analysis for complex analytical issues and provide scientifically sound solutions. Author high-quality technical documents, including method development reports, validation protocols and reports, and relevant sections for regulatory filings (IND, CTA, NDA). Ensure all work is conducted in accordance with established SOPs and cGMP principles. Required Qualifications & Experience Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related field. A minimum of 2-5 years of post-PhD experience in peptide analysis within a pharmaceutical, biotech, or CDMO setting. Exceptional new PhD graduates with a strong publication record in peptide analysis will also be considered. Extensive hands-on experience with a wide range of analytical techniques, with proven expertise in: HPLC/UPLC (UV, DAD, CAD) LC-MS and LC-MS/MS for peptide characterization Capillary Electrophoresis (CE) Solid understanding of peptide chemistry, degradation mechanisms, and ICH guidelines (Q2(R1), Q3, Q6) pertaining to analytical method validation and specifications. Experience in a GMP environment is required. Direct experience contributing to regulatory filings is highly preferred. Excellent analytical, problem-solving, and critical thinking skills. Strong written and verbal communication skills in English, with the ability to effectively present complex data. Proactive, self-motivated, and able to manage multiple tasks efficiently in a fast-paced, project-driven environment. A collaborative team player with the ability to work effectively across different functions. How to Apply Interested candidates should submit their CV/resume, a cover letter detailing their relevant experience and research interests to zhizhong.zhang@sinopep.com Get notified about new Senior Scientist jobs in
San Diego, CA .
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Senior Scientist, Peptide Analysis (Ph.D.) About Us Sinopepi s a leading China-based CDMO partner focused on accelerating the discovery, development, and manufacturing of innovative Peptide and oligonucleotide therapeutics. We provide integrated solutions from preclinical to commercial supply, leveraging state-of-the-art facilities and deep scientific expertise. Join our dynamic team and contribute to advancing the next generation of genetic medicines for global partners. Position Summary We are seeking a highly skilled and innovative Ph.D. Scientist to join our Analytical Development team as a Senior Scientist, Peptide Analysis. This role is central to designing and executing advanced analytical strategies for the characterization and quality control of peptide-based drug substances and products. The ideal candidate is a hands-on expert in peptide analysis, with a deep theoretical and practical understanding of modern chromatographic and spectroscopic techniques. You will be a key technical contributor, driving quality research for client projects from early-stage development through to regulatory submissions. Key Responsibilities Independently design, develop, optimize, and validate robust, stability-indicating analytical methods for peptides (e.g., U/HPLC-UV/MS, CE, LC-MS/MS for identity, purity, impurities, and assay). Lead method transfer activities to the QC team or to client sites. Perform comprehensive characterization of synthetic peptides, including primary structure confirmation by LC-MS/MS, peptide mapping, and the identification and quantification of process-related impurities and degradation products. Serve as a subject matter expert (SME) in peptide analysis for internal teams and external clients. Lead root cause analysis for complex analytical issues and provide scientifically sound solutions. Author high-quality technical documents, including method development reports, validation protocols and reports, and relevant sections for regulatory filings (IND, CTA, NDA). Ensure all work is conducted in accordance with established SOPs and cGMP principles. Required Qualifications & Experience Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related field. A minimum of 2-5 years of post-PhD experience in peptide analysis within a pharmaceutical, biotech, or CDMO setting. Exceptional new PhD graduates with a strong publication record in peptide analysis will also be considered. Extensive hands-on experience with a wide range of analytical techniques, with proven expertise in: HPLC/UPLC (UV, DAD, CAD) LC-MS and LC-MS/MS for peptide characterization Capillary Electrophoresis (CE) Solid understanding of peptide chemistry, degradation mechanisms, and ICH guidelines (Q2(R1), Q3, Q6) pertaining to analytical method validation and specifications. Experience in a GMP environment is required. Direct experience contributing to regulatory filings is highly preferred. Excellent analytical, problem-solving, and critical thinking skills. Strong written and verbal communication skills in English, with the ability to effectively present complex data. Proactive, self-motivated, and able to manage multiple tasks efficiently in a fast-paced, project-driven environment. A collaborative team player with the ability to work effectively across different functions. How to Apply Interested candidates should submit their CV/resume, a cover letter detailing their relevant experience and research interests to zhizhong.zhang@sinopep.com Get notified about new Senior Scientist jobs in
San Diego, CA .
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