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吸入制剂研究高级工程师
30-45K/月广东省-深圳/硕士及以上/5-10年
邱豪一周前来过
东莞市拓广人力资源咨询有限公司四川营山分公司
职位详情
岗位职责
制剂配方高级工程师/制剂配方专家
Senior Engineer/Expert in Formulation Formulation
职责描述
Job Description
1. 负责OINDP（口鼻吸入制剂）的预配方、配方和工艺开发。
1. Responsible for the pre formulation, formulation, and process development of OINDP (Oral and Nasal Inhalation Formulation).
2. 设计和执行配方试验、分析测试和评估稳定性数据，以最终确定配方组成。
2. Design and execute formula experiments, analyze testing and evaluate stability data to ultimately determine the composition of the formula.
3. 开发配方的制造工艺，使大规模批量的技术转让成功。
3. Develop manufacturing processes for formulas to facilitate successful large-scale technology transfer.
4. 负责所有配方/工艺相关的CMC文件，这些文件将作为监管文件的一部分。
4. Responsible for all CMC documents related to formulas/processes, which will be part of regulatory documents.
5. 编写/审查主配方、制造程序、SOP、稳定性协议/报告、工艺验证协议/报告以及产品和工艺开发报告等。
5. Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, and product and process development reports.
6. 制定/审查药品和包装组件的规范等。
6. Develop/review specifications for drugs and packaging components, etc.
7. 负责制造过程从实验室规模到生产规模的技术转让。
7. Responsible for technology transfer in the manufacturing process from laboratory scale to production scale.
8. 与分析方法开发、监管事务、质量控制、质量保证、运营等部门合作，加快cFDA对新产品的开发和批准。
8. Collaborate with departments such as analytical method development, regulatory affairs, quality control, quality assurance, and operations to accelerate the development and approval of new products by cFDA.
9. 确保根据公司程序和cGLP将所有配方和工艺开发活动记录在案。
9. Ensure that all formula and process development activities are documented in accordance with company procedures and cGLP.
10. 为实践和系统的持续改进提供建议，以提高性能，提高效率和质量。
10. Provide suggestions for continuous improvement in practice and systems to enhance performance, efficiency, and quality.
11. 积极参与获得产品、工艺或设备的专利，与外部供应商和实验室沟通。
11. Actively participate in obtaining patents for products, processes, or equipment, and communicate with external suppliers and laboratories.
任职要求
Job requirements
1. 对制药行业，特别是药物输送行业，以及配方和工艺开发有深入的了解；
1. Have a deep understanding of the pharmaceutical industry, especially the drug delivery industry, as well as formulation and process development;
2. 了解GMP法规；
2. Understand GMP regulations;
3. 药学及相关领域硕士以上学位，博士优先，至少3年相关工作经验；
3. Master's degree or above in pharmacy and related fields, with a priority given to a doctoral degree, and at least 3 years of relevant work experience;
4. 能开展英语口语交流，优先获得前往美国迈阿密的工作或出差机会。
4. Able to engage in English oral communication and prioritize the opportunity to work or travel to Miami, USA.
Senior Engineer/Expert in Formulation Formulation
职责描述
Job Description
1. 负责OINDP（口鼻吸入制剂）的预配方、配方和工艺开发。
1. Responsible for the pre formulation, formulation, and process development of OINDP (Oral and Nasal Inhalation Formulation).
2. 设计和执行配方试验、分析测试和评估稳定性数据，以最终确定配方组成。
2. Design and execute formula experiments, analyze testing and evaluate stability data to ultimately determine the composition of the formula.
3. 开发配方的制造工艺，使大规模批量的技术转让成功。
3. Develop manufacturing processes for formulas to facilitate successful large-scale technology transfer.
4. 负责所有配方/工艺相关的CMC文件，这些文件将作为监管文件的一部分。
4. Responsible for all CMC documents related to formulas/processes, which will be part of regulatory documents.
5. 编写/审查主配方、制造程序、SOP、稳定性协议/报告、工艺验证协议/报告以及产品和工艺开发报告等。
5. Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, and product and process development reports.
6. 制定/审查药品和包装组件的规范等。
6. Develop/review specifications for drugs and packaging components, etc.
7. 负责制造过程从实验室规模到生产规模的技术转让。
7. Responsible for technology transfer in the manufacturing process from laboratory scale to production scale.
8. 与分析方法开发、监管事务、质量控制、质量保证、运营等部门合作，加快cFDA对新产品的开发和批准。
8. Collaborate with departments such as analytical method development, regulatory affairs, quality control, quality assurance, and operations to accelerate the development and approval of new products by cFDA.
9. 确保根据公司程序和cGLP将所有配方和工艺开发活动记录在案。
9. Ensure that all formula and process development activities are documented in accordance with company procedures and cGLP.
10. 为实践和系统的持续改进提供建议，以提高性能，提高效率和质量。
10. Provide suggestions for continuous improvement in practice and systems to enhance performance, efficiency, and quality.
11. 积极参与获得产品、工艺或设备的专利，与外部供应商和实验室沟通。
11. Actively participate in obtaining patents for products, processes, or equipment, and communicate with external suppliers and laboratories.
任职要求
Job requirements
1. 对制药行业，特别是药物输送行业，以及配方和工艺开发有深入的了解；
1. Have a deep understanding of the pharmaceutical industry, especially the drug delivery industry, as well as formulation and process development;
2. 了解GMP法规；
2. Understand GMP regulations;
3. 药学及相关领域硕士以上学位，博士优先，至少3年相关工作经验；
3. Master's degree or above in pharmacy and related fields, with a priority given to a doctoral degree, and at least 3 years of relevant work experience;
4. 能开展英语口语交流，优先获得前往美国迈阿密的工作或出差机会。
4. Able to engage in English oral communication and prioritize the opportunity to work or travel to Miami, USA.
任职要求
无
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公司信息
东莞市拓广人力资源咨询有限公司四川营山分公司
- 南充
- 20-99人
- 其他行业
- 民营
- 无
