AOC Analytical Dev. Sr. Manager/ Associate Director
Shanghai R&D1.Build and lead a team responsible for analytical method development of AOCs and antibodies.
2.Guide CDMOs in method qualification and validation, including compendial and product-specific testing methods, in compliance with global regulatory guidelines.
3.Develop phase-appropriate specifications and quality control strategies for Drug Substance (DS) and Drug Product (DP).
4.Establish and manage stability study programs for DS/DP to support retest/expiry dates aligned with clinical and regulatory timelines.
5.Author and review analytical development/validation reports, stability reports, and analytical sections for IND/IMPD and BLA/MAA filings. 6.Review and perform QC of batch analytical data packages.
7.Troubleshoot analytical issues and OOS investigations with CROs/CDMOs.
8.Serve as the Analytical representative in cross-functional teams (e.g., Drug Substance, Drug Product, QA, Clinical, Nonclinical, and CDMO QC/QA).
9.Assist in drafting responses to health authority inquiries.
10.Present project updates, including critical issues, at team meetings.
11. Manage budgets for analytical development activities.
1.PhD or Mphil in Analytical Chemistry, Biochemistry, or a related field.
2.PhD with 5+ , Mphil with 8+ years of analytical development experience in biopharmaceuticals, with expertise in mAb and ADC method development and characterization, experience in BsAb is preferred.
3.Strong technical knowledge and practical experience at part of following analytical techniques, including: HPLC/UPLC, SEC, LC-MS, HIC, CE-SDS, ELISA, icIEF, and Cell-Based Assays.
4.Proven track record in: Managing analytical/testing activities in-house and at CDMOs (from Phase I to commercialization) for mAbs/BsAb and ADC.
5.Preparing analytical sections for IND/IMPD and BLA/MAA filing for mAbs/BsAb and ADC.
6.Excellent written/verbal communication and data presentation skills (e.g.,publication-quality graphs/tables).
7.Meticulous attention to detail, with a focus on data accuracy and QC.
8.Ability to collaborate effectively in cross-functional teams.
9.Adaptability in a fast-paced biotech environment, balancing research and development priorities.
10.Passion for contributing to innovative therapies for serious disease.
Purification and Analytical Scientist
Shanghai R&D1.Develop and optimize purification methods for peptides, nucleic acids, and related products, including the study and implementation of salt form conversion processes.
2.Perform reversed-phase preparative purification of samples ranging from milligram to gram scale, and proficiently use preparative HPLC for the separation and preparation of target compounds such as peptides and nucleic acids.
3.Manage and perform routine maintenance on HPLC, LC-MS, and reversed-phase preparative chromatography systems, and promptly resolve common instrument issues.
4.Coordinate with the synthesis department to understand their needs, develop reasonable purification work plans, and ensure timely delivery of qualified samples.
5.Maintain clear, complete, and accurate experimental records to ensure data traceability and compliance.
6.Oversee routine laboratory EHS management and other daily operational tasks.
7.Complete other tasks assigned by supervisors.
1.Education: Associate degree or above in analytical chemistry, pharmaceutical analysis, pharmacy, or a related field.
2.Experience: Hands-on experience in the separation and purification of peptides and small nucleic acid compounds. Prior experience at a top-tier domestic CRO or CDMO company is preferred. Familiarity with lyophilization processes and optimization is a plus.
3.Technical Skills: Proficient in developing purification methods for peptides and nucleic acids, as well as salt form conversion processes. Skilled in operating HPLC, LC-MS, and reversed-phase preparative systems, with the ability to troubleshoot common instrument issues and perform routine maintenance.
4.Core Competencies: Strong sense of responsibility, willingness to learn, team-oriented spirit, and good communication skills. Proactive work attitude, ability to work under pressure, and strong execution capability.
Peptide Synthesis Scientist
Shanghai R&D1.Assist in the establishment and development of the peptide platform within the department.
2.Demonstrate proficiency in organic synthesis and peptide synthesis.
3.Participate in project progress reporting and discussions.
4.Assist in the management of laboratory equipment, documentation, files, safety, and intermediates.
5.Conduct literature searches and share findings; design synthetic routes.
6.Complete other tasks assigned by supervisors.
1.Bachelor's or Master's degree in organic chemistry, medicinal chemistry, pharmacy, or a related field.
2.3–5 years of experience in organic synthesis, with 1–3 years of peptide synthesis experience preferred.
3.Full-process experience in peptide synthesis, with familiarity and the ability to independently operate peptide synthesizers.
4.Strong sense of responsibility, willingness to learn, team-oriented spirit, and good communication skills.
5.Prior experience at a top-tier domestic CRO company is preferred.
Senior Patent Manager
Shanghai R&D1.Conduct patent information research for the company's R&D pipeline, including patent searches, FTO (Freedom to Operate) analyses, and patentability assessments.
2.Perform regular tracking and risk analysis for company projects, and monitor updates on pharmaceutical-related patent laws and case law developments in the market.
3.Manage patent mining, portfolio development, drafting, filing, and office action responses for company projects.
4.Oversee intellectual property early warning activities for company projects, including but not limited to patent risk tracking and analysis, design-around strategies, and patent challenge responses (e.g., third-party observations, invalidation challenges), and address IP disputes and countermeasures.
5.Participate in IP due diligence for company out-licensing, financing, and other related activities.
6.Contribute to the company's IP process management.
7.Participate in the formulation and revision of the company's IP system policies, develop annual IP plans, and ensure their effective implementation.
8.Fulfill other duties as required in the protection of intellectual property rights.
9.Complete other tasks assigned by supervisors.
1.Bachelor's degree or above in chemistry, biology, pharmacy, or a related field, with 3–5+ years of hands-on patent practice experience in the pharmaceutical industry. Experience in both small nucleic acid (oligonucleotide) and large molecule (biologics) fields is preferred.
2.Solid patent drafting skills and proficiency in pharmaceutical information retrieval. Familiarity with SciFinder and various patent search databases is preferred.
3.Ability to independently draft patent applications and handle office actions. A Patent Agent Qualification Certificate is preferred. Familiarity with patent laws and regulations in China, the US, Europe, and other major jurisdictions is required.
4.English proficiency as a working language, with the ability to read English literature, independently draft English patent applications, handle office actions and other documents in English, and participate in English-language meetings.
5.Excellent communication and teamwork skills.
6.Proactive, self-motivated, and capable of independent learning and problem-solving.
Oligo Synthesis Senior Scientist
Shanghai R&D1.Oversee the daily operations of the solid-phase synthesis team, reasonably allocate task assignments, balance workload saturation, and set project priorities to ensure projects advance as scheduled.
2.Supervise team work quality, drive efficiency improvements and continuous optimization, and promote the development of stable, reproducible workflows.
3.Mentor team members and provide technical training to enhance the team's overall capabilities in synthesis, post-synthesis processing, problem analysis, and project delivery.
4.Coordinate the synthesis, post-processing, and delivery of oligonucleotides and related research materials based on project requirements and timelines.
5.Liaise with upstream and downstream units including solid-phase synthesis, post-processing, analytical purification, and product/sample management to ensure timely and accurate project information transfer.
6.Identify and resolve chemistry-, reaction-, process-, equipment-, or operation-related issues encountered during project execution to safeguard delivery quality and schedule.
7.Organize Root Cause Analysis (RCA) based on reaction results, and drive the implementation of corrective and preventive actions to close out issues.
8.Maintain team issue logs, technical summaries, case reviews, and best practice documentation to support the departmental knowledge base and competency matrix development.
9.Ensure that experimental records, project reports, and relevant technical documents are authentic, complete, accurate, and traceable.
10.Manage routine laboratory maintenance, equipment usage, and on-site order to ensure compliance with company EHS and quality system requirements.
11.Complete other tasks assigned by supervisors.
1.Bachelor's degree or above in organic chemistry, medicinal chemistry, pharmacy, chemical engineering, materials chemistry, biochemistry, or a related field.
2.Demonstrated experience in team management, project management, or cross-functional coordination, with the ability to break down tasks, assess priorities, allocate resources, and track outcomes.
3.Strong capability in chemical problem analysis and resolution, with the ability to diagnose issues based on reaction observations, analytical data, and experimental records, and drive effective solutions.
4.Excellent learning ability, communication and coordination skills, strong sense of responsibility, and a results-oriented mindset, with the ability to ensure team delivery quality under project pressure.
5.Experience in oligonucleotide solid-phase synthesis technology and team management is preferred.
6.Experience in operating solid-phase synthesizers such as Mermade 12/48/192 or OP10/100, or in post-synthesis processing including deprotection/cleavage and lyophilization, is preferred but not required.
7.Ability to support compound quality assessment and problem analysis using LC-MS/MS, HPLC, and other analytical data is preferred.
Oligo Synthesis Scientist
Shanghai R&D1.Perform solid-phase synthesis for the preparation of small nucleic acids.
2.Ensure project timelines are met and deliverable quality standards are achieved.
3.Interpret LC-MS and other spectral data, analyze impurities, and optimize synthesis steps and workflows.
4.Maintain synthesizers and related equipment.
5.Communicate project issues promptly, resolve problems, and document findings in issue logs and technical summaries.
6.Prepare experimental reports and provide regular work updates.
7.Track project progress in a timely manner, respond to cross-functional communications, and ensure smooth information flow throughout the project.
8.Complete other tasks assigned by supervisors.
1.Bachelor's degree or above in organic chemistry, pharmacy, or a related field.
2.Familiarity with solid-phase synthesis and proficiency in operating one or more of the following synthesizers: Mermade 12/48/192, OP10/100, etc., with demonstrated ability to perform post-synthesis workup procedures including deprotection/cleavage (ammonolysis) and lyophilization.
3.Ability to perform structural analysis and characterization of compounds using LC-MS/MS, HPLC, and other analytical instruments and methods.
4.Strong learning ability, team-oriented mindset, professionalism, sense of responsibility, and meticulous attention to detail.
Oligo Purification Scientist
Shanghai R&D1.Operate, manage, and perform routine maintenance on analytical and preparative instruments such as LC-MS and preparative HPLC, and be capable of troubleshooting common instrument issues.
2.Develop purification methods for small nucleic acid molecules and complete sample purification and preparation.
3.Perform quality testing of purified fractions, fraction pooling, and lyophilization.
4.Support the reaction testing needs of various synthesis teams and provide timely feedback on spectral/analytical results.
5.Release small nucleic acid single-stranded intermediates and double-stranded products based on LC-MS results in accordance with quality standards.
6.Back up analytical and purification data.
7.Assist in issuing ROA (Report of Analysis) documents.
8.Carry out routine laboratory EHS and other daily operational tasks.
9.Complete other tasks assigned by supervisors.
1.Bachelor's degree or above in analytical chemistry, organic synthesis, instrumental analysis, pharmacy, or a related field.
2.At least 3 years of experience in drug synthesis, or at least 1 year of experience in analytical/preparative chromatography.
3.Strong sense of responsibility, willingness to learn, team-oriented spirit, and good communication skills.
4.Proactive work attitude, ability to work under pressure, and strong execution capability.
5.Experience in small nucleic acid synthesis, analysis, or purification is highly preferred.
Project Management (Oligo Drug Delivery)
Shanghai R&D1.Project assignment and progress management: control the timing of key milestones within the workflow of the conjugation team in the oligonucleotide department.
2.Resource coordination: coordinate laboratory equipment and material tracking to ensure adequate project resource supply.
3.Cross-departmental collaboration: communicate with upstream and downstream units to facilitate the transfer of samples and materials both internally and externally for the oligonucleotide department.
4.Personnel management and training: organize training on project management processes and material handover procedures to enhance team members' project management skills and overall team collaboration efficiency.
5.Quality oversight: supervise the quality of compounds delivered by the conjugation team within the oligonucleotide department to ensure compliance with quality standards.
6.Issue logging: identify and document work-related issues, and maintain an issue log.
7.Risk response: identify potential project risks, propose solutions, and optimize workflows accordingly.
8.Complete other tasks assigned by supervisors.
1.Familiarity with the core business processes of the small nucleic acid conjugation team.
2.Demonstrated knowledge of project management combined with experience in team collaboration.
3.Proficiency in Excel data processing.
Oligo Conjugation Scientist Ⅱ
Shanghai R&D1.Perform conjugation of single-stranded or double-stranded small nucleic acids with various types of molecules.
2.Design optimal synthetic routes and reaction parameters, and deliver small nucleic acid conjugates rapidly and in accordance with quality requirements.
3.Assist in building the team's technical capabilities in small nucleic acid conjugation.
4.Manage assigned projects efficiently and with clear documentation.
5.Interpret LC-MS spectra, analyze the sources of impurities, and optimize synthetic methods to eliminate impurity origins.
6.Communicate project issues in a timely manner and possess the ability to resolve technical challenges.
7.Prepare experimental reports and regularly report on workload and progress.
8.Complete other tasks assigned by supervisors.
1.4+ years of experience in small nucleic acid bioconjugation is preferred.
2.Bachelor's degree or above in organic chemistry or a related field, with a solid theoretical foundation in organic chemistry.
3.Strong timeline management awareness and excellent interpersonal communication skills.
4.Good project reporting and project management capabilities.
Oligo Conjugation Scientist
Shanghai R&D1.Execute established reaction conditions, provide feedback on process details, and assist in further process optimization.
2.Perform conjugation reactions between small nucleic acids and small molecules, and track the progress and material status of assigned projects.
3.Handle annealing, quantification, and delivery of samples within the team.
4.Report work progress and issues, and ensure the quality of delivered outputs.
5.Complete other tasks assigned by supervisors.
1.Bachelor's degree.2+ years of experience in organic synthesis.
2.Proficient in using analytical instruments and methods such as LC-MS and HPLC to evaluate reaction outcomes and troubleshoot reaction issues accordingly.
3.Strong learning ability, team-oriented mindset, professionalism, sense of responsibility, and meticulous attention to detail.
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