2027届-精英计划-研发-分析方法开发与项目分析管理方向-XDC/BDK

Responsibilities:

1. Lead Analytical Activities in CMC Projects

(1) Serve as the function leader or sponsor in Analytical Sciences, leading analytical efforts in CMC projects.

(2) Collaborate with internal experts and cross-functional CMC teams to design and execute tailored analytical studies that comply with regulatory standards and meet project objectives.

(3) Provide continuous scientific and technical support for project monitoring, proactively identify potential issues, and offer timely, constructive solutions.

(4) Prepare and review analytical sections for regulatory submission dossiers, including INDs and BLAs.

2. Analytical Method Development and In-depth Mass Spectrometry Characterization

(1) Develop and optimize physicochemical and mass spectrometry methods for critical quality attributes such as purity, impurities, drug-to-antibody ratio (DAR), molecular weight determination, peptide mapping analysis, post-translational modification analysis, disulfide bond characterization, and conjugation site identification.

(2) Perform in-depth characterization and comparability assessments for critical batches of drug substances and drug products using LC-MS/MS and high-resolution mass spectrometry platforms.

(3) Demonstrate competency in troubleshooting, optimizing, and implementing challenging and innovative assays, and participate in daily instrument operation, maintenance, and troubleshooting.

3. Client Engagement and Technical Support

(1) Communicate analytical progress directly with domestic and international clients, resolve technical challenges encountered during projects, and ensure alignment with client expectations.

(2) Provide scientific guidance and technical support to process development teams (conjugation, purification, formulation) through in-process testing and data interpretation.

4. Talent Development and Continuous Improvement

(1) Foster talent development within the team by sharing expertise and best practices in analytical techniques and project management.

(2) Drive continuous improvement initiatives to enhance analytical efficiency, data quality, and cost-effectiveness.

5. Documentation and Regulatory Compliance

(1) Author and review technical documents including but not limited to method development reports, method

protocols and reports, standard operating procedures (SOPs), comparability study protocols and reports, and regulatory filing dossiers, ensuring strict compliance with regulatory requirements.

(2) Maintain high standards of data integrity and documentation practices.

6. Instrumentation and Laboratory Management

(1) Oversee operation, calibration, maintenance, and troubleshooting of liquid chromatographs, high-resolution mass spectrometers, and other advanced analytical instruments.

(2) Ensure laboratory compliance with EHS, 5S, and quality management systems.

(3) Participate in laboratory public affairs and training activities.

岗位要求：

Qualifications:

1. Master or Ph.D. in analytical chemistry, biochemistry, protein science, or related disciplines, with specialized training in HPLC/UPLC, CE/iCIEF, or MS techniques.

2. Proficient understanding of HPLC/CE/MS principles and technologies, with hands-on experience in operation, maintenance, and troubleshooting of HPLC/CE/MS instruments.

3. Demonstrated expertise in physicochemical analysis and structural characterization of proteins and bioconjugates is highly preferred.

4. Strong team player with exceptional interpersonal, communication, and presentation skills (both written and verbal).

5. Proven track record as a proactive, independent researcher with advanced problem-solving skills and multitasking abilities.

6. Proficient in English communication, including reading, listening, writing, and speaking.

您将得到的培训：

1. 实验技能培训：帮助您快速达到当前岗位的技术资质要求，掌握一项或多项技术，包括抗体偶联药物的理化分析、质谱表征等相关实验研究，具体实验技能包括以下：

（1）理化分析Physicochemical analysis (HPLC/UPLC, CE, iCIEF etc.)

（2）蛋白质结构表征Protein structure characterization (Mass Spec, Glycosylation/Carbohydrate, UV-CD, SEC-MALs, Fluorescence, DLS, DSC etc.)

（3）药典和其它常规分析 Compendial or other general assays (appearance, pH, osmolality, UV280, etc.)

（4）稳定性样品管理Stability sample management

（5）标准品和样品管理Reference standard and sample management

2. 在岗专业知识培训：

（1）熟悉各类生物偶联药物研发特点和机理，掌握高效合理安排时间的诀窍，从先导化合物筛选，到临床各阶段的分子，再到上市阶段的药物，各个阶段分析知识的掌握，提升您的核心竞争力。

（2）锻炼严谨的科研思路及实验习惯，能够系统地设计实验，并有较强的实验执行能力及计划性，能客观地分析实验数据结果。

（3）提升在项目实验操作、执行方面的发现及解决问题的能力。

3. 安全意识和知识培训：公司拥有系统完备的安全培训教材和经验丰富的培训讲师。

4. 英语培训：专门的英语培训机构及暑期国外著名大学的学生来公司开展口语培训课程。

5. 月度学术报告：邀请世界知名的科学家、公司技术大咖来公司讲座。

6. 管理技能培训：请公司高层及著名培训机构进行培训，提高员工的实践和理论知识。

职业发展：

Career Development:

1. Embrace a multi-level, diversified talent training and development system at WuXi XDC, comprehensively developing general skills, technical capabilities, and leadership.

2. Gain extensive technical experience for biopharmaceutical analysis through WuXi XDC’s global technology platform.

3. Accumulate abundant CMC project experience over a few years, not only in bioconjugate analysis but also in process development, manufacturing, and regulatory submissions.

4. Have the opportunity to learn, work, and grow with WuXi XDC for long-term career development.