Sinopep-Allsino Biopharmaceutical Co., Ltd. ยท 12 hours ago
Senior Scientist -Oligonucleotide Process Development
San Diego, CA
Full-time
Onsite
Mid, Senior Level
0+ years expSinopep-Allsino Biopharmaceutical Co., Ltd. is a leading CDMO partner focused on innovative oligonucleotide therapeutics. They are seeking a highly motivated PhD Scientist to lead the design, development, and optimization of chemical processes for therapeutic oligonucleotides, ensuring seamless project execution and collaboration with cross-functional teams.
Pharmaceuticals
Responsibilities
Lead Oligonucleotide Process Development : Design, plan, execute, and analyze experiments to develop and optimize solid-phase (SPOS) and/or solution-phase synthesis processes for complex oligonucleotides (including modified nucleotides, conjugates)
Purification & Analytical Focus: Develop, optimize, and scale chromatographic purification strategies (e.g., RP-HPLC, IE-HPLC, AEX) for crude oligonucleotides. Integrate analytical methods (HPLC, UPLC, MS, CE, UV, NMR) for process monitoring, impurity characterization, and control strategy development
Scale-Up & Technology Transfer : Lead the scale-up of developed processes from laboratory to pilot plant and ultimately to GMP manufacturing scales. Author robust technical transfer documents and provide hands-on support during transfer activities
Process Characterization & Validation: Contribute to or lead process characterization studies (e.g., identification of Critical Process Parameters - CPPs) to establish proven acceptable ranges (PARs) and support process validation (PPQ) activities
Innovation & Problem Solving: Proactively identify process bottlenecks, inefficiencies, or quality issues and develop innovative, scientifically sound solutions. Explore novel technologies and methodologies to enhance synthesis, purification, or analytical capabilities
Data Analysis & Documentation: Rigorously analyze experimental data, draw sound scientific conclusions, and maintain accurate, detailed laboratory notebooks and electronic records. Prepare high-quality technical reports, development reports, and sections of regulatory submissions (e.g., CMC modules)
Cross-Functional Collaboration: Work effectively with Analytical Development, Manufacturing, Project Management, Quality Assurance (QA), and Quality Control (QC) teams to ensure seamless project execution and alignment with client timelines and quality standards
External Communication: Present scientific results clearly and concisely to internal stakeholders and external clients. Participate in technical discussions and project meetings
Mentorship (Potential): Provide technical guidance and mentorship to junior scientists and research associates
Qualification
Required
PhD in Organic Chemistry, Medicinal Chemistry, Biochemistry, Chemical Engineering, or a closely related field
0-5 years of relevant industrial experience (post-PhD) in oligonucleotide process R&D within a pharmaceutical, biotech, or CDMO setting. Exceptional new PhD graduates with a strong focus on oligonucleotide synthesis/chemistry will be considered
Deep understanding of oligonucleotide chemistry (phosphoramidite synthesis, protecting groups, coupling efficiency, side reactions)
Proven hands-on experience in developing and optimizing oligonucleotide synthesis processes (SPOS required; solution-phase a plus)
Extensive experience with oligonucleotide purification techniques, particularly preparative HPLC (RP, IE, AEX)
Strong proficiency in analytical techniques for oligonucleotide characterization (HPLC/UPLC, MS, CE, UV-Vis, NMR interpretation)
Experience with process optimization, troubleshooting, and scale-up principles
Company
Sinopep-Allsino Biopharmaceutical Co., Ltd.
Sinopep is a trusted CDMO specializing in end-to-end CMC development and cGMP manufacturing of peptide and oligonucleotide APIs for NCEs, from early-phase development to commercialization.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase