IT Infrastructure Supervisor / Senior Supervisor
Shanghai Operations1.IT Infrastructure Operations Management: Responsible for the daily operations, monitoring, troubleshooting, and optimization of the company's existing self-built data center and global IT infrastructure. Ensure stable, efficient, and secure operation of office networks and IT systems across 3 office locations serving approximately 300 employees. Undertake the iteration and maintenance of the existing mature infrastructure architecture.
2.Core Network Operations: Lead the configuration, debugging, upgrade, routine inspection, and troubleshooting of the company's full range of H3C network equipment (switches, routers, firewalls, wireless APs, etc.). Oversee global network architecture planning, subnet segmentation, routing policy optimization, VLAN management, and network access control. Resolve various network issues including latency, outages, loops, and cross-region connectivity problems, ensuring stable connectivity across office networks, business system networks, and data center networks.
3.Security and Server Operations: Maintain daily security policies, conduct routine inspections, analyze logs, perform risk assessments, and handle security incidents for Sangfor security devices (firewalls, web filtering, VPN, endpoint security, etc.). Regularly optimize security policies to prevent network attacks, data breaches, and unauthorized access. Manage the Lenovo server cluster, including server deployment, hardware inspections, performance monitoring, fault repair, disk array management, and backup strategy implementation, ensuring reliable enterprise data storage and business system hosting.
4.Architecture Optimization and Upgrades: Based on business growth needs, conduct regular reviews of the existing network, security, and server infrastructure. Identify architectural bottlenecks and develop optimization, capacity expansion, and upgrade plans. Lead infrastructure iteration projects to continuously improve the availability, security, and scalability of the IT infrastructure.
5.End-User Support and Policy Implementation: Provide IT infrastructure support for all employees, resolving issues related to network access, endpoints, office network permissions, VPN connectivity, etc. Develop and refine operational policies and standard operating procedures for data center, network, security, and server operations. Establish standardized operational workflows and maintain accurate records of operations, inspections, and changes.
6.Project and Asset Management: Participate in IT infrastructure-related new construction, renovation, and expansion projects, taking responsibility for project implementation, testing, and acceptance. Oversee asset inventory management for network devices, security appliances, servers, and other IT infrastructure assets, conducting regular inventories to ensure compliance and control.
7.Industry Compliance Assurance: Align IT infrastructure operations with the specific requirements of the biopharmaceutical industry, ensuring that network security, data storage, and system operations comply with regulatory standards and corporate internal controls. Support internal and external audits and compliance inspections.
1.Education and Experience: Associate's degree or above in Computer Science, Network Engineering, Information Technology, or a related field. Minimum 5 years of enterprise IT infrastructure operations experience, with at least 2 years in a team supervisor or senior operations management role. Candidates with pharmaceutical industry IT operations background, hands-on experience managing Microsoft 365 products, proficiency in English, and familiarity with ITIL frameworks and process implementation are strongly preferred. Experience in medium-to-large enterprises is a plus.
2.Core Technical Skills (Required): Deep expertise in network architecture principles and operations. Proficiency in configuring, maintaining, and troubleshooting the full range of H3C network equipment. Strong knowledge of LAN/WAN architecture, routing and switching, VPN, wireless networking, and cross-subnet communication, with the ability to independently resolve complex network issues.
3.Supporting Technical Skills: Proficiency in configuring security policies, conducting routine inspections, implementing security防护 measures, and handling incidents for Sangfor security products. Familiar with Lenovo server hardware architecture, system deployment, cluster operations, and data backup/recovery, with hands-on experience in self-built data center operations.
4.Competencies: A well-structured approach to IT infrastructure operations management, with the ability to independently drive architecture optimization, incident coordination, and project delivery. Strong problem-solving skills to quickly identify and resolve network, security, and server incidents. Excellent organizational, communication, and team management skills, with the ability to effectively coordinate operations across multiple office locations.
5.Certifications (Preferred): Advanced certifications from H3C, Sangfor, Huawei, Cisco, or other major vendors are preferred.
6.Professional Qualities: Meticulous, responsible, and detail-oriented. Strong service mindset and ability to work under pressure. Familiar with standardized enterprise IT operational processes and committed to strictly adhering to corporate compliance and information security policies.
AOC Quality Manager / Senior Manager
Shanghai QM1.Supplier Management: Oversee CMOs for upstream/downstream DS (Drug Substance) and DP (Drug Product) in AOC (Antibody-Oligonucleotide Conjugation), as well as material and service suppliers. Participate in the full supplier lifecycle management, including: pre-qualification and compliance review of new suppliers, maintenance and updates of supplier files, periodic supplier performance reviews, handling and follow-up of supplier complaints, and updating/maintaining the approved supplier list. Conduct supplier audits, including developing and executing audit plans, drafting audit reports, confirming corrective actions, and tracking CAPA (Corrective and Preventive Actions) status. Take responsibility for drafting, reviewing, and executing Quality Agreements with CMOs/CDMOs, clearly defining responsibilities for material release, in-process controls, product release, stability studies, and data integrity, and ensure effective implementation of such agreements.
2.Project Support: Collaborate with the AOC CMC team to review product-related quality and technical documents throughout the manufacturing process, including: specifications, analytical methods, process procedures, batch production records, batch packaging records, analytical method validation/verification protocols and reports, stability study protocols and reports, and product co-line risk assessment documents. Work with CMOs to manage product-related quality events, including: changes, deviations, OOS/OOT/OOE, risk assessments, memos, etc., to ensure product quality and manufacturing process compliance. Ensure that the quality management system covers the entire product lifecycle from technology transfer, clinical sample production, to commercial manufacturing, and that products consistently meet registered approval requirements. On-site Monitoring: Be stationed at or regularly visit CMO production sites to provide on-site oversight of the entire DS upstream/downstream and DP manufacturing processes.
3.Product Release: Collect and organize all documents related to product release, and review the release documentation package, including: batch production records, batch packaging records, batch testing records and COAs, raw material test results, single-use system component test results, environmental monitoring data, and quality events associated with the specific batch.
4.Complete other tasks assigned by supervisors.
1.Full-time bachelor's degree or above in Biology, Biochemistry, Pharmacy, Chemistry, or a related field.
2.8–10+ years of quality assurance (QA) experience in the pharmaceutical industry, with at least 3 years specifically focused on large-molecule biologics (monoclonal antibodies, fusion proteins, ADCs, or gene therapies).
3.Deep understanding of CHO cell culture, protein purification (affinity, ion exchange, hydrophobic interaction chromatography), formulation filling, and ADC conjugation processes. Experience in sterile product quality management (injectables, lyophilized powders), with in-depth knowledge of aseptic processing and biologics manufacturing.
4.Strong GMP compliance mindset, with thorough knowledge of domestic and international GMP regulations and guidelines.
5.Excellent internal and external communication, coordination, and teamwork skills. Demonstrated ability to negotiate "firm yet professional"—upholding quality standards while effectively resolving conflicts between business needs and quality requirements.
6.Adaptable to a moderate frequency of business travel.
7.Fluent in English (both written and spoken), with the ability to use English as a working language.
CMC Analytical Senior manager/AD
Shanghai CMC1.Lead the quality research efforts for DS/DP across different clinical phases of the company's siRNA new drug programs: Apply QbD (Quality by Design) principles to guide the establishment of quality specifications and the development, validation, and stability studies of analytical methods for siRNA drug substances, APIs, formulations, and intermediates. Provide technical guidance for analytical studies across different clinical phases, process validation, and commercial manufacturing, and support regulatory submissions in China, the US, and Europe.
2.Coordinate with CDMO analytical teams during project manufacturing, track project analytical progress, and draft or review relevant documents and reports.
3.Collaborate with the Regulatory Affairs department to draft, review, and finalize IND and NDA submission dossiers for project-related sections, and assist in regulatory filings, registration testing, and on-site inspections.
4.Independently develop and validate analytical methods for raw materials, intermediates, APIs, and finished products, and conduct stability studies in accordance with relevant regulations.
5.Ensure proper operation, routine maintenance, and simple troubleshooting of analytical instruments and equipment; maintain laboratory management to keep the lab clean and organized.
6.Support the Quality department in establishing and managing compliance systems.
7.Contribute to departmental system development; summarize and share lessons learned from project issues or errors in a timely manner to continuously improve project execution efficiency.
8.Complete other tasks assigned by supervisors.
1.Bachelor's degree with 8+ years, or Master's degree with 5+ years of experience in pharmaceutical analysis or related fields (pharmacy, pharmaceutical analysis background preferred).
2.5+ years of experience in new drug R&D analysis, with the ability to independently develop and validate analytical methods; familiar with ICH guidelines and pharmacopoeia requirements in China, the US, and Europe.
3.Proficient in operating and understanding the principles of analytical instruments such as HPLC, LC-MS, UV spectrophotometers, and Karl Fischer moisture titrators.
4.Proven experience in regulatory filings, with the ability to author IND/NDA submission dossiers.
5.Knowledge of current GMP requirements (China, US, or EU); strong GMP compliance awareness and good documentation practices.
6.Excellent organizational, communication, and coordination skills; high sense of responsibility, strong work ethic, and ability to handle pressure.
7.Strong English writing skills, with the ability to draft various reports in English based on templates; conversational English communication skills preferred.
8.Self-motivated and adaptable to moderate-frequency business travel.
Oligo CMC Process Senior manager/AD
Shanghai CMC1.Manage the process development content of assigned projects, overseeing both progress and quality. This includes: designing process study plans, supervising plan execution and troubleshooting, reviewing process development reports, reviewing process specifications and batch records, approving manufacturing batch records, auditing qualified suppliers, conducting on-site production inspections and production support, and managing procurement of critical materials—covering all work related to API process and manufacturing.
2.Manage production schedules, ensure on-time delivery of materials and study reports, and coordinate upstream/downstream timelines.
3.Draft regulatory submission dossiers and assist in completing filing/registration activities.
4.Conduct oligonucleotide CMC process experiments, including process range studies, impurity studies, and other process performance investigations—draft study protocols, execute experiments, and author study reports.
5.Maintain equipment used in oligonucleotide CMC process development, including drafting and revising SOPs, conducting training, performing routine equipment maintenance, and other day-to-day laboratory management tasks.
6.Complete other tasks assigned by supervisors.
1.Bachelor's degree or above in a chemistry/chemical process-related field, with good communication skills.
2.10+ years of CMC process experience, with multiple IND filing track records.
3.Demonstrated experience in API process development and production management.
4.Strong timeline management awareness and excellent English communication skills.
5.Outstanding project reporting and project management capabilities.
6.Additional requirements: Proficient in computer-aided tools such as Office, ChemDraw, Visio, and CAD; able to respond promptly to abnormal events, deviations, and other ad-hoc issues during manufacturing; willing to travel domestically/internationally as planned or unplanned, and able to be stationed at partner sites for project management when required.
Oligo CMC Process Scientist
Shanghai CMC1.Responsible for drafting and revising CMC process-related documents, and preliminary review of work documents and reports from partners.
2.Responsible for data consolidation and process report writing for the CMC process.
3.Responsible for drafting registration dossiers to support regulatory submissions.
4.Responsible for preliminary review of manufacturing documents.
5.Responsible for material procurement, starting material management, and other process development and API production operations support.
6.Responsible for conducting internal process research experiments.
7.Complete other tasks assigned by supervisors.
1.Bachelor's degree or above in a chemistry-related field, with basic English writing skills.
2.2+ years of CMC process experience in small nucleic acids, with a solid understanding of fundamental organic chemistry principles.
3.Detail-oriented and patient personality.
4.Strong timeline management awareness.
5.Willing to travel for production support and on-site work with partners when project needs arise.
Principal Process Scientist I
Shanghai CMC1.Responsible for chemical reaction optimization, route development, and process development within the department.
2.Solve chemical challenges and guide subordinates to complete their work effectively.
3.Participate in the management of laboratory equipment, materials, documents, safety, and intermediates.
4.Conduct literature searches and sharing, as well as route design.
5.Participate in project progress reporting and discussions, including collaboration with third parties, timely follow-up on project progress, and resolution of related issues.
6.Complete other tasks assigned by superiors.
7.Draft Standard Operating Procedures (SOPs).
1.Ph.D. degree with a minimum of 5 years of work experience.
2.Proficient in organic experimental techniques, with strong data retrieval skills and awareness of advanced organic chemistry frontiers.
3.Ability to solve synthetic problems based on reaction mechanisms.
4.Strong planning and communication skills, meticulous and organized work habits, with a high sense of responsibility and professionalism.
5.Preference will be given to candidates with work experience in top domestic CRO or CDMO companies.
Process Scientist
Shanghai CMC1.Lead chemical reaction optimization, route scouting, and process development within the department.
2.Solve complex chemical challenges and provide guidance to subordinate team members to ensure successful task completion.
3.Participate in the management of laboratory equipment, documentation, files, safety, and intermediates.
4.Conduct literature searches, share findings, and design synthetic routes.
5.Participate in project progress reporting and discussions, including collaboration with third-party partners, timely follow-up on project advancement, and resolution of related issues.
6.Complete other tasks assigned by supervisors.
7.Draft and author SOPs.
1.Ph.D. graduate with at least 2 years of work experience.
2.Proficient in organic laboratory techniques, with strong data retrieval capabilities and awareness of (tracking) cutting-edge advances in organic chemistry.
3.Ability to resolve synthesis-related challenges based on mechanistic understanding of reactions.
4.Strong planning and communication skills; meticulous, organized, detail-oriented, with a strong sense of responsibility and professional dedication.
5.Prior experience at a top-tier domestic CRO or CDMO company is preferred.
CMC Analytical Associate Scientist
Shanghai CMC1.Sample and Reference Standard Management and Sample Shipment: Oversee the full lifecycle management of all samples (including intermediates, drug substance, drug product, stability samples, etc.) and reference standards (reference materials, standards, impurity controls, etc.) within the CMC analytical department, covering receipt, registration, storage, issuance, return, and disposal. Maintain sample and reference standard inventory logs/systems to ensure consistency between physical counts and records, information traceability, and compliance with GMP/GLP requirements. Conduct regular inventory checks and reconciliations, and promptly handle materials approaching or beyond their expiration dates to ensure regulatory compliance and safety. Coordinate with internal departments including process development, formulation, regulatory affairs, quality assurance, and project management to facilitate sample transfers, handovers, usage needs, and timelines. Manage external sample shipments to CROs/CDMOs, partners, testing laboratories, stability outsourcing facilities, etc. Prepare appropriate packaging, transport conditions (e.g., refrigerated, frozen, ambient), and shipping documentation (e.g., COA, MSDS, invoices, customs declarations) to ensure safe, compliant, and traceable delivery.
2.Instrument Procurement and Management: Assist the department head in procurement requisitions, vendor inquiries, price comparisons, contract signing, and qualification follow-up for analytical instruments (e.g., HPLC, LC-MS, UV, KF, pH meters), chromatography columns, and consumables. Establish and maintain instrument equipment files, including procurement contracts, acceptance reports, calibration certificates, maintenance logs, and repair records, ensuring complete documentation, clear categorization, and easy access. Develop and maintain the departmental annual instrument calibration schedule, track the progress of calibration, verification, and intermediate checks to ensure all instruments are used within their calibration validity periods. Collect, review, archive, and index calibration reports, and update calibration status information in instrument inventory records in a timely manner. Establish and maintain full lifecycle archives for instruments, including basic equipment information, procurement details, acceptance records, calibration certificates, maintenance and repair records, qualification/validation documents (e.g., IQ/OQ/PQ), and decommissioning requests, ensuring compliance with GMP traceability requirements. Conduct regular self-audits and updates of instrument archives, and cooperate with the administration department in internal and external audits related to instruments.
3.Departmental Common Task Reminders and Compliance Checks: Coordinate periodic reminders and follow-ups for departmental common tasks, including but not limited to instrument usage log entries, column usage registration, reagent and consumable usage records, laboratory notebook archiving, and equipment maintenance. Regularly inspect departmental common records (e.g., instrument usage logs, temperature records, cleaning logs) to verify completeness, timeliness, and compliance, and promptly notify relevant personnel to address any deficiencies. Assist the department head in establishing and continuously optimizing inspection checklists and reminder mechanisms for common tasks to ensure compliant and efficient daily operations. Conduct routine inspections of departmental common areas (e.g., laboratories, office spaces), promptly report any anomalies, and coordinate corrective actions.
4.Systematization and Process Optimization: Assist in managing departmental internal SOPs, including but not limited to sample management processes, instrument management processes, document archiving procedures, and common task inspection processes. Participate in the continuous improvement of the departmental quality management system, collect feedback and issues encountered in daily operations, and promote process optimization and standardization. Support new employee training and orientation on departmental processes and SOPs to facilitate smooth integration into the departmental management system.
5.Stability Report Tracking: Monitor and track departmental stability study sample plans and progress, including stability sample placement, timely reminders of sampling time points, and verification of sampling execution. Assist in managing stability reports, including data compilation, collection and archiving of reports, and timely escalation and tracking of out-of-trend results. Maintain communication with project management, quality assurance, and other departments to ensure stability studies are conducted as scheduled and meet regulatory submission requirements.
6.Project Document Archiving: Oversee the archiving and indexing of all project-related documents (including process descriptions, analytical methods, validation protocols and reports, stability protocols and reports, release test reports, COAs, regulatory submission dossiers, etc.) from each project lead within the department. Establish and maintain project document archiving logs to ensure clear version control, easy accessibility, and compliance with data integrity requirements. Coordinate the collation, transfer, and archiving of project documents upon project completion, ensuring proper long-term preservation in accordance with regulatory standards.
7.Invoice and Expense Management: Collect, verify, organize, and submit reimbursement requests for invoices related to departmental procurement (instruments, consumables, reagents, services). Assist the department head in tracking budget execution and expense reporting to ensure clarity and compliance. Maintain effective communication with finance and procurement departments to ensure smooth purchasing and reimbursement workflows.
8.Complete other related tasks assigned by supervisors.
1.Bachelor's degree or above in pharmacy, chemistry, biology, pharmaceutical engineering, or a related field.
2.Minimum 2 years of relevant experience in an analytical laboratory or R&D department within the pharmaceutical industry. Experience in sample/reference standard management, instrument archive management, and document archiving processes is preferred.
3.Familiarity with daily laboratory management requirements under the GMP system is preferred.
4.Knowledge of basic GMP/GLP requirements, with a strong awareness of proper documentation practices and quality management.
5.Proficiency in Microsoft Office applications (Excel, Word, PowerPoint). Experience with laboratory management systems (LIMS, ELN) or instrument management software is preferred.
6.Basic understanding of the principles and maintenance knowledge of common analytical instruments (e.g., HPLC, LC-MS, UV) is preferred.
7.Experience in developing and tracking instrument calibration schedules and monitoring stability reports is preferred.
8.Experience in process optimization and SOP writing is preferred.
9.Core Competencies: Meticulous and detail-oriented, with strong sense of responsibility, execution capability, and proactiveness. Good organizational and coordination skills, with strong cross-departmental communication and collaboration awareness. Highly organized, with effective time management and ability to handle multiple tasks simultaneously. Demonstrated ability to identify and resolve issues, and to propose process improvement suggestions. Basic proficiency in both Chinese and English (reading and writing) to handle routine English documents such as COAs, calibration certificates, shipping documents, etc.
CMC Analytical Senior Scientist (Project Management)
Shanghai CMC1.Conduct or guide CROs in the development and optimization of analytical methods for intermediates, drug substance (DS), and drug product (DP). Actively participate in technical discussions during the development process and provide technical support.
2.Coordinate and follow up on quality research activities according to the established quality research plan. Review analytical documents related to quality research for intermediates, DS/DP at different clinical stages, including but not limited to analytical methods, validation protocols and reports, reference standard qualification protocols and reports, stress study protocols and reports, stability protocols and reports, release specifications, and COAs.
3.Actively participate in discussions on technical issues arising during project execution and assist in resolving project-related problems.
4.For in-house quality research work, prepare relevant records and reports in accordance with applicable SOPs, and perform data trend analyses or rationality assessments.
5.Support the process development team in method development and specification establishment for specialized monomers, and provide laboratory analytical support when necessary.
6.Assist in routine laboratory management.
7.Collaborate with the regulatory affairs team to draft regulatory submission dossiers according to established templates and requirements, and review relevant documents and attachments.
8.Complete other tasks assigned by supervisors.
1.Bachelor's degree with 8+ years of experience, or Master's degree with 5+ years of experience in pharmaceutical analysis or a related field. Experience in oligonucleotide quality research is highly preferred. A Master's degree is preferred.
2.Solid theoretical knowledge and hands-on skills in pharmaceutical analysis. Proficient in operating common analytical instruments such as HPLC, GC, UV, LC-MS, and KF. Capable of independently developing and validating routine analytical methods, and able to promptly resolve common technical issues encountered during experiments.
3.Strong organizational and coordination skills, good communication and problem-solving abilities. Meticulous and rigorous work ethic, with a high sense of responsibility and proactiveness, and the ability to work under pressure.
4.Ability to draft analytical sections of IND/NDA regulatory submission dossiers according to established templates.
5.Good GMP compliance awareness and proper documentation practices.
6.Familiarity with technical English in pharmaceutical analysis, with the ability to draft or review English documents based on provided templates.
7.Strong self-learning ability and initiative.
8.Equipment: HPLC, LC-MS, UV-Vis spectrophotometer, pH meter, analytical balance, KF, etc.
9.Ability to travel on a moderate frequency.
Hyaluronidase Manager / Senior Manager
Shanghai R&D1.Manage CDMOs to carry out process development, analytical method development, scale-up, GMP manufacturing, AOC (antibody-oligonucleotide conjugate) drug substance and drug product manufacturing, process changes, and process validation for hyaluronidase drug substance and drug product.
2.Draft and/or review departmental technical documents related to hyaluronidase, CDMO technical and GMP manufacturing documents, and regulatory submission dossiers.
3.Participate in antibody process development and AOC conjugation/purification process development as needed.
4.Contribute to routine maintenance and management of the process development laboratory, draft SOPs for equipment and experimental operations, and organize, report, and interpret/evaluate experimental data.
5.Serve as a process technology expert to facilitate technical communications with other functional teams and CDMOs.
6.Complete other tasks assigned by supervisors.
1.Master's degree or above in pharmacy, biochemistry, biotechnology, or a related field.
2.More than 5 years of experience (or 2 years for Ph.D. holders) in process development and analytical method development for macromolecular protein drugs, particularly recombinant enzymes. Experience in hyaluronidase development is preferred.
3.Completion of at least one IND-stage process development project (cell culture, purification, or formulation) for a recombinant enzyme product. Experience in BLA-stage process characterization studies is preferred. Experience in authoring hyaluronidase IND or hyaluronidase co-formulation product IND dossiers for dual (China-US) filing with successful regulatory approval is preferred.
4.For purification process development candidates: proficiency in operating AKTA purification systems, with in-depth understanding and hands-on experience in recombinant enzyme production processes and quality control methods.
5.Familiarity with regulatory requirements for biological products, particularly ICH, FDA, and EU guidelines.
6.Knowledge of GMP manufacturing management requirements and applicable regulations at different stages of biologics development.
7.Alignment with the company's values and development direction.
8.Other (special circumstances): Hands-on laboratory work is required; domestic business travel may be necessary.
为了更好的呈现效果，移动端请竖屏浏览
