理化分析研究员/副高级研究员 Physicochemical Analytical Scientist/Senior Scientist

1. Review GMP analytical records and data, including release and stability testing records, method qualification, validation and transfer study records, as well as other analytical records such as training and feasibility study records.
2. Monitor routine analytical testing data and trends, proactively identify potential abnormal or atypical trends, and escalate observations as appropriate.
3. Provide audit and inspection support for analytical data review processes and ensure review activities are performed in compliance with applicable GMP requirements and internal procedures.
4. Maintain and revise controlled documents related to analytical data review, including SOPs, TRAs, and other applicable procedures or guidance documents.
5. Perform routine analytical testing in accordance with approved Standard Operating Procedures (SOPs), Analytical Method Procedures (AMPs), protocols, test methods, and applicable cGMP requirements, as needed.
6. Support analytical method qualification, transfer, and validation activities, including discussion and development of project-specific strategies in accordance with applicable internal SOPs.
7. Support QC project management activities, including but not limited to preparation and review of specifications, release testing protocols, and stability testing protocols.
8. Coordinate and communicate internal and external QC activities to support project timelines, testing execution, document readiness, and product release.
9. Support investigation, troubleshooting, and continuous improvement activities related to analytical testing and data review, as applicable.

Experience

1. Experience working in a Quality Control laboratory, analytical development laboratory, or other relevant GMP-regulated environment is preferred.
2. Knowledge and hands-on experience in at least one of the following analytical areas is required:

• Biochemical assays: ELISA, cell-based assays, qPCR, Western blot, enzyme activity testing, or related techniques.
• Separation assays: HPLC/UPLC, CE-SDS, iCIEF, or related separation techniques.
• Biophysical assays: Mass spectrometry (MS), UV spectroscopy, or related biophysical analytical techniques.

1. Experience in GMP analytical data and record review is preferred, particularly for release, stability, method qualification, validation, or transfer activities.
2. Knowledge or experience in analytical method qualification, validation, and method transfer is preferred.
3. Experience with laboratory computerized systems such as LIMS, chromatography data systems, or other electronic laboratory systems is desirable.
4. Proficiency in Microsoft Word, Excel, and PowerPoint is required.

Qualifications

• Bachelor's or Master's degree in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular Biology, Biological Engineering, or a related scientific discipline.
• Relevant experience in pharmaceutical, biopharmaceutical, biotechnology, or GMP Quality Control is preferred.
• Good understanding of cGMP requirements, data integrity principles, and GMP documentation practices is preferred.

Behavioral Competencies

1. Strong attention to detail and quality mindset, with the ability to identify potential inconsistencies or abnormalities in analytical data and documentation.
2. Strong critical thinking, scientific reasoning, troubleshooting, and problem-solving skills.
3. Good communication skills in both English and Chinese, with the ability to communicate effectively in written and verbal formats.
4. Ability to work both independently and collaboratively in a cross-functional team environment.
5. Ability to effectively manage multiple priorities in a fast-paced GMP environment and adjust workload according to changing project requirements.
6. Strong sense of ownership and accountability, with the ability to proactively drive assigned activities to completion.
7. Ability to communicate and collaborate effectively with internal stakeholders and external clients on QC-related technical and project activities.
8. Demonstrates a strong commitment to quality, compliance, data integrity, and applicable regulatory requirements.

, validation, and transfer activities, as well as monitoring routine analytical data trends and supporting audit readiness. The position will also support analytical method lifecycle activities and QC project management, including method qualification, validation and transfer strategy development, preparation of GMP documents, and coordination of internal and external QC activities.

Essential Duties and