Job Description:

• 按需求，参与或负责完成溶瘤病毒或抗体项目，自免药物早期研发的背景调研、新科学策略和实验方法的开发等工作；
• 合理制定实验研究方案，高效合规完成药物的体内外功能评估等实验内容，收集数据和分析整理实验结果并完成研究报告，能够撰写相关文档支持临床申报；
• 根据项目需要参与或负责与其他团队以及第三方CRO机构的沟通，跟踪相关任务进度，监督CRO研究质量和审核研究数据；
• 参与到公司的SOP建立和更新；
• 实验室日常维护以及完成上级安排的其他工作。

Qualification:

• 专业要求：分子/细胞生物学，生物化学，免疫学等生物相关学科博士，有良好的英文文献阅读能力，能够独立制定研究方案和撰写研究报告；
• 至少1年以上大分子生物医药研发经验，熟悉肿瘤免疫治疗或者自免类疾病治疗药物的研究并掌握常用的实验技术，包括细胞培养，病毒包装，基因编辑，细胞死亡的检测，细胞因子检测，免疫荧光，流式检测，基因检测等。具备良好的实验习惯和数据处理分析、解决问题的能力；
• 熟练使用office办公软件和Prism、Flowjo、Snapgene等专业分析软件；
• 工作态度积极主动，反馈及时，严谨细致，责任心强，具备良好的理解表达沟通能力和团队配合精神，能够高效组织和执行项目；
• 有肿瘤免疫治疗和抗体类药物开发项目经验优先，有参与IND申报经验者优先，有参与实验室管理经验者或带团队经验优先；

Job Description:

• Facilitate to identify and select trial vendors, including but not limited to CROs, Labs, SMOs for clinical studies together with other stakeholders. Negotiate the quotation and contract.
• Require, manage and coordinate the study resource internally and externally.
• Set-up and/or lead the study team (internal & external) to set up and review study plans including timeline, trial supplies, essential documents and all other plans (project management plan, monitoring plan, training plan, and etc.) properly.
• Oversee and manage the clinical operational activities with CROs, third-party vendors, consultants and internal personnel to execute clinical studies to ensure that the studies proceed according to the plans.
• Oversee study start-up, conduct and close-out activities, including site feasibility.
• Oversee clinical site monitoring activities and review/approve monitoring visit reports.
• Oversee the trial quality by conducting co-monitoring visits, lead risk & issue identification and resolution, and other related quality activities.
• Manage CRO, third-party vendors and consultant’s work, including review and approval of scope of work, contract, budget and invoices.
• Develop collaborative relationships with internal partners, external organizations, key opinion leaders, and investigators.
• Collaborate with CRO study directors and project managers to foresee and solve problems.
• Consult and coordinate with the internal medical team, drug supply team and external consultants regarding the design and conduct of studies.

Qualification:

• Bachelor’s degree or master’s degree in a medicine-related discipline.
• At least 5 years of working experience including 1.5-3 years of clinical operations project management experience.
• Experience with clinical studies in Australia or US is a plus.
• Knowledge of the relevant drug development process including project and site management, local and international regulations, ICH-GCP, drug safety requirements, data management processes, budget and vendor management and other functions or industry knowledges.
• Ability to travel extensively within country and rarely for Intercontinental trave as well.
• Excellent communication skills.
• Fluent written and spoken English, and proficiency in Chinese is a plus (for abroad candidates only).
• Ability to handle high volume of work and tight deadlines.
• Proficiency in MS Office, including Word, Excel, and PowerPoint.

Job Description:

• 负责管理由Pyrotech内部研发活动产生的创新产品非临床开发工作，涵盖从先导候选化合物筛选至监管申报与审批通过的全流程。
• 统筹协调毒理学研究、安全药理学评估、生物分析及DMPK（药物代谢与药代动力学）等非临床研究活动，确保项目在全生命周期内的高效推进。
• 保障非临床研究交付成果与文件资料的及时性及合规性，满足临床试验申请、监管机构沟通及全球市场注册要求（包括研究者手册IB、研发期间安全性更新报告DSUR、年度报告AR、预审评会议资料pre-IND、临床试验申请IND/CTA及新药上市申请NDA等）。
• 定期向内部相关项目团队汇报非临床研究进展，主导与CRO（合同研究组织）等外部合作伙伴的沟通协作，推动非临床研究执行。

Qualification:

• 具有药理学、毒理学或相关学科硕士以上学位。
• 具备至少3年在生物医药行业非临床药物开发方面的工作经验。
• 对CDE、FDA和国际注册的要求以及非临床安全药理学和毒理学相关的指导方针(ICH、EMA)有较深入的理解。
• 具备优秀的沟通和协作技能，确保与内部团队和外部合作者的有效互动与合作。
• 英语读写流利，口语熟练。

Job Description:

• 独立并高质量地完成动物模型的构建，支持候选药物分子在大、小鼠体内的药效学研究。
• 执行动物实验操作，包括药物配制、给药、疾病指标监测、解剖、生物组织样本采集及制备等操作。
• 及时、准确、完整地进行实验数据的收集、整理及归档，并对实验数据进行初步的处理及分析。
• 严格遵守实验方案、标准化操作流程。
• 协调并参与实验室管理相关工作。
• 协助新实验技术、平台的开发和搭建，不断优化现有的技术和流程，高效率完成日常工作。

Qualification:

• 生物学、动物医学、药学或相关专业的大专或者本科学历。
• 本科5年及以上（大专8年及以上）体内药理学或啮齿动物研究相关工作经验。
• 丰富的啮齿类动物实验操作相关工作经验，包括但不限于抓取与保定、多种途径的给药及生物样本的采集和制备、尸检解剖、疾病进展监测及临床观察等相关实验操作。
• 具备炎症、自免、代谢等多领域的相关工作经验，熟悉并掌握相关疾病动物模型的搭建。
• 具备体内药物筛选、药代动力学、药效动力学评价的相关工作经验。
• 良好的实验记录及文档管理习惯。
• 良好的团队合作精神和沟通能力，执行能力强，能独立思考解决问题。
• 积极主动，有主人翁意识和不断进取的自我驱动力，能迅速适应不断变化的需求及工作优先级的变化，具备同时处理多件工作的能力，并能根据工作的优先级调整工作顺序。

Job Description:

• Overall responsibility for drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies. 
• Identification, selection and management of Contract Development and Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP).
• Develop and implement strategy and design of experimentation for optimizing and controlling quality of bulk API and DP using CDMO. 
• Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile.
• Projection of API and DP needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance team). 
• Formulation design/development in support of clinical studies.
• Management of supply chain and logistics in support of clinical studies. 
• In coordination with Quality Assurance, implement stage appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with all relevant regulatory standards.
• Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and NMPA / FDA regulations. 
• Writing and reviewing documents for INDs / regulatory section submissions; represent the company as the CMC expert before China and U.S. regulatory authorities. 
• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents. 
• Prepare technical reports, publications and oral presentations. 

Qualification:

• Substantial experience in managing China and International CDMOs for the manufacture of cGMP APIs and DP.
• Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 including multiple pharmaceutical dosage forms (e.g. tablets, capsules, topicals, etc.) .
• Experienced with cGMP manufacturing and IND and NDA filings; thorough knowledge of relevant NMPA and FDA regulations. 
• At least 10 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment. 
• Experience in supply chain management .
• PhD or MS with 10+ years of experience; Advanced degree in Organic Chemistry or related scientific discipline is preferred. 
• Able to identify and resolve critical issues. 
• Experience implementing technical, strategic and operational plans. 
• Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).