Senior Scientist QC Microbiology

Position Summary | 职位概述

The Senior Scientist, QC Microbiology is responsible for microbiological testing, laboratory investigations, validation activities, and QC microbiology laboratory operations at WuXi Biologics. This role will provide scientific and technical leadership to ensure compliance with regulatory requirements, support product quality, and drive continuous improvement initiatives.

高级科学家（QC微生物）负责GMP环境下微生物检测、实验室调查、验证活动及QC微生物实验室运营管理工作。该岗位将提供专业技术支持，确保实验室符合GMP法规要求，保障产品质量，并推动持续改进。

Key Responsibilities | 主要职责

1. Microbiological Testing | 微生物检测

Perform and oversee routine microbiological testing in accordance with GMP requirements and approved procedures.

按照GMP要求和批准的操作规程开展并监督常规微生物检测工作。

Conduct and review:

Sterility testing

Bioburden testing

Bacterial endotoxin testing (Gel-clot and Kinetic methods)

开展并审核：

无菌检查

微生物限度/生物负载检测

细菌内毒素检测（凝胶法及动态法）

Analyze testing data and ensure result accuracy, integrity, and compliance.

分析检测数据，确保结果准确性、完整性和合规性。

Support method qualification, troubleshooting, and continuous improvement activities.

支持方法确认、技术问题排查及持续改进活动。

2. Validation Studies | 验证工作

Design, execute, and review microbiology-related validation studies, including:

Cleaning Validation

Disinfection Validation

Sterilization Validation

负责微生物相关验证项目的方案制定、执行及审核，包括：

清洁验证

消毒验证

灭菌验证

Prepare protocols, reports, risk assessments, and technical documentation.

编写验证方案、报告、风险评估及相关技术文件。

Provide microbiological expertise during facility and process qualification activities.

为设施及工艺确认项目提供微生物专业支持。

3. QC Laboratory Operations | QC实验室运营

Support daily operation and management of the QC Microbiology laboratory.

支持QC微生物实验室日常运营与管理。

Lead or participate in:

Laboratory investigations

Root cause analysis

CAPA implementation

Deviation investigations

Change controls

主导或参与：

实验室调查

根本原因分析

CAPA制定与实施

偏差调查

变更管理

Ensure laboratory compliance with GMP requirements and data integrity principles.

确保实验室符合GMP要求及数据完整性要求。

Prepare, review, and approve SOPs, protocols, reports, and technical documents.

编写、审核并批准SOP、方案、报告及技术文件。

Support internal audits, customer audits, and regulatory inspections.

支持内部审计、客户审计及法规检查。

4. Cross-functional Collaboration | 跨部门协作

Collaborate with QA, Manufacturing, Engineering, Validation, and other departments to resolve microbiology-related issues.

与QA、生产、工程、验证等部门合作解决微生物相关问题。

Provide scientific guidance and technical training to team members.

为团队成员提供技术指导和培训。

Support continuous improvement and operational excellence initiatives.

支持持续改进及卓越运营项目。

Qualifications | 任职要求

Education | 教育背景

Bachelor's Degree, or Master's Degree in Microbiology, Biochemistry, Molecular Biology, or related life science disciplines.

微生物学、生物化学、分子生物学或相关生命科学专业，本科或硕士学历。

Experience | 工作经验

Minimum 5 years of relevant experience in QC Microbiology within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment.

具有至少5年制药、生物技术或生命科学行业GMP环境下QC微生物相关工作经验。

Hands-on experience in laboratory investigations, CAPA, deviations, and change controls is required.

具有实验室调查、CAPA、偏差管理及变更控制实际经验。

Competencies | 能力要求

Strong understanding of GMP regulations and quality systems.

熟悉GMP法规及质量体系要求。

Strong analytical and problem-solving skills.

具备优秀的问题分析与解决能力。

Excellent technical writing and documentation skills.

良好的技术写作和文件编写能力。

Effective communication and cross-functional collaboration skills.

良好的沟通协调及跨部门合作能力。

Ability to work independently and manage multiple priorities.

能够独立工作并高效管理多项任务。

Good English reading and writing skills.

具备良好的英文读写能力。