湖州招聘

Key tasks include:

1. Playing strategic role in building science-based, clinical appropriate and regulatory appropriate CMC strategic plans balanced with time and cost;
2. Developing detailed timelines, cost, deliverables and acceptance criteria for each CMC function at different stages of tech transfer, process development, clinical manufacturing, late-phase process development, product characterization and process validation;
3. Monitoring and controlling the entire process of CMC Development through collaboration with CMOs, and ensure it to align with the timeline, budget, deliverables and acceptance criteria, and to follow the GMP and regulatory requirements;
4. Scheduling and coordinating project team and governance meetings; Leading presentation and discussion of each CMC function; issuing high quality agendas and meeting minutes in a timely manner; accountable for action item follow up;
5. Involved in reviewing of all CMO documents from protocols to records and reports, to ensure the scientific logic, integrity, traceability of documentations; summarizing project progress and technical data from each CMC function; developing summary reports and registration dossier following clinical and regulatory requirements.
6. Working both internally with CMC team members and externally with CMOs to proactively identifies, resolves/mitigates and escalates risks and/or issues; communicates openly and timely on project specific priorities; supports team leads in prioritizing and contingency planning;

                            

Requirements

1. A Bachelor of Science in scientific fields (e.g. Biology, Chemistry, Engineering, or Pharmacy) required. Advanced degree (Masters or PhD in a scientific discipline) is preferred but not required.
2. 3+ years biologics drug development experience in one or multiple fields of upstream/ downstream/ analytical/ formulation/ QC/ QA of CMC development and prior experience in supporting pre-clinical and/or clinical-stage drug development programs.
3. Capable to write and review English technical documents. Fluent oral English is a plus.
4. Self-motivated, and eager to learn; strong ownership, and ability to follow through with direction/tasks; proactive and positive when facing challenges.
5. Comfortable working in a team environment, and can motivate and help others to achieve CMC goals with team efforts.
6. Good skills in common word processing tools (such as Words, PowerPoint, Excel, and MS Project).

    我们是中国领先的综合医药公司。我们的愿景是凭借我们经市场验证的完整价值链能力，成为专注于抗感染、心血管疾病及呼吸系统三个核心治疗领域“放眼全球、服务中国”的领先医药公司。

    一方面，我们致力于不断引入全球优质医药资源，拥有世界级生产设施和全球供应链，采用国际标准的运营管理，且领导团队具备国际视野；另一方面，经过近二十年的不断探索，我们凭借对中国市场的深刻洞见，构建起规模化的高效商业化平台和高标准的本土生产基地，并取得卓越的运营表现。

    我们相信“放眼全球、服务中国”的双轮驱动模式，能帮助我们更好地服务中国市场，为患者持续提供优质的全球医疗产品和服务。