API Specialist/Group Leader
奥贝泰克药物化学（天津）有限公司北京办事处
- 公司规模：50-150人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-02-12
- 工作地点：天津
- 招聘人数：若干人
- 职位月薪：1-1.5万/月
- 职位类别：生物工程/生物制药
职位描述
职位描述：
Job Responsibilities:
1. Assist in the investigation and resolution of: technical, quality, and regulatory issues related to active ingredients for new products, alternate and commercial API with regard to out of specifications/rejections, certificate of analysis, impurities, reference standards, manufacturing site relocations, DMF deficiencies, DMF changes, and specification changes.
2. Work closely with Apotex’s Analytical groups (new product development, commercial, Chemical and Physical Properties Group) and manufacturers in coordinating data and information (i.e., supplier methods and results etc.) for all quality related investigations (i.e., Out of Specifications, Out of Trend/rejections etc.) surrounding active ingredients, in an effort to resolve current drug product back order situations or in support of drug product filings.
3. Interpretation of analytical results (i.e., HPLC, GC, physical properties etc.) and their correlation with the formulation parameters and physical operations in the API manufacturing facility, in an effort to proactively avoid potential supply problems.
4. Communicate with suppliers on facility, equipment and capacity to ascertain the processing capability of the suppliers. Draft, send and review supplier questionnaire on the above information. Develop and maintain database of the above information to be easily accessible to others within the group.
5. Contribute and review response plans with manufacturers and Apotex internal groups, so as to not disrupt the supply chain for DMF deficiencies.
6. Assist the coordination of new product development projects for supplier site and process changes between the external manufacturers, Apotex R&D and analytical, regulatory affairs, project management and Global API Technical (GAPIT) to ensure a seamless submission process.
7. Work closely and assist Apotex’s alternate sourcing and changes to the API process and facility and resolve any technical or quality related issues and communicating these issues to the suppliers as necessary.
8. Work with the procurement group and the sourcing hubs for supply of new product development and Commercial API and reference standards.
9. Coordinating with the API sourcing hubs and API evaluation sites on testing of evaluation samples provided by various API suppliers.
10. Provide comparative data on new and alternate source API for decision on source selection.
11. Assist Global API Technical (GAPIT) Managers in mining of Apotex and supplier’s data and developing trends to identify potential failures to avoid back order scenarios.
12. Efficient use of the sourcing hubs in communicating with various suppliers to get submission documents for both New Product Development (NPD) and commercial sources.
13. Assist in specifications revisions (monograph updates or new project status), as well as industry initiatives, coordinating between Apotex and the suppliers.
14. Assist Global API Technical (GAPIT) Managers in the sourcing of API manufacturers for new product development and commercial projects.
15. Represent Global API Technical (GAPIT) as requested by Apotex internal groups regarding issues pertaining to API, so that these problems can be efficiently addressed with the supplier.
16. Assist Apotex’s alternate sourcing and supplier driven changes (SDC program) by participating in the API Performance Improvement Team meetings to resolve any technical or quality related issues and communicating these issues to the suppliers as necessary.
17. Maintain New Product Development (NPD and alternate source database and API comparison tables.
18. Lead or participate in initiatives for the improvement of internal processes that affect API supplier qualification or API release (e.g. SOP, sharing of data, methods and specification development, OOS investigation processes etc.).
19. Coach and assist other groups on API technical matters as required.
20. Works as a member of a team to achieve all outcomes.
21. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
22. Performs all work in accordance with all established regulatory and compliance and safety requirements.
23. Performs all other tasks and duties as may, from time to time, be assigned (e.g., confidentiality disclosure agreements).
Job Requirements:
? M.Sc., B.Sc. or B. Eng. in Chemistry or Chemical Engineering, Pharmaceutical or Health Sciences required.
? 5-10 years of experience in the pharmaceutical industry is required.
? Must have API plant manufacturing and process control experience along with milling, powder processing and unit operations involved in the manufacture of an API.
? Must have experience with analytical testing of API and drug product with hands on experience with HPLC, GC, and Malvern.
? Must possess knowledge of the technical, quality, and regulatory issues related to the qualifying of a drug substance.
? Must possess the ability to provide explanations or solutions to a variety of problems of moderate scope and complexity.
? Ability to read and interpret complex technical documents. Ability to write detailed business correspondence.
? Ability to work with managers or directors and communicate ambiguous concepts.
? Excellent communication and interpersonal skills.
? Strong organizational skills; ability to work independently and manage priorities
? Demonstrated knowledge of the generic new product development process.
? Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS Outlook and MS-Excel.
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Job Responsibilities:
1. Assist in the investigation and resolution of: technical, quality, and regulatory issues related to active ingredients for new products, alternate and commercial API with regard to out of specifications/rejections, certificate of analysis, impurities, reference standards, manufacturing site relocations, DMF deficiencies, DMF changes, and specification changes.
2. Work closely with Apotex’s Analytical groups (new product development, commercial, Chemical and Physical Properties Group) and manufacturers in coordinating data and information (i.e., supplier methods and results etc.) for all quality related investigations (i.e., Out of Specifications, Out of Trend/rejections etc.) surrounding active ingredients, in an effort to resolve current drug product back order situations or in support of drug product filings.
3. Interpretation of analytical results (i.e., HPLC, GC, physical properties etc.) and their correlation with the formulation parameters and physical operations in the API manufacturing facility, in an effort to proactively avoid potential supply problems.
4. Communicate with suppliers on facility, equipment and capacity to ascertain the processing capability of the suppliers. Draft, send and review supplier questionnaire on the above information. Develop and maintain database of the above information to be easily accessible to others within the group.
5. Contribute and review response plans with manufacturers and Apotex internal groups, so as to not disrupt the supply chain for DMF deficiencies.
6. Assist the coordination of new product development projects for supplier site and process changes between the external manufacturers, Apotex R&D and analytical, regulatory affairs, project management and Global API Technical (GAPIT) to ensure a seamless submission process.
7. Work closely and assist Apotex’s alternate sourcing and changes to the API process and facility and resolve any technical or quality related issues and communicating these issues to the suppliers as necessary.
8. Work with the procurement group and the sourcing hubs for supply of new product development and Commercial API and reference standards.
9. Coordinating with the API sourcing hubs and API evaluation sites on testing of evaluation samples provided by various API suppliers.
10. Provide comparative data on new and alternate source API for decision on source selection.
11. Assist Global API Technical (GAPIT) Managers in mining of Apotex and supplier’s data and developing trends to identify potential failures to avoid back order scenarios.
12. Efficient use of the sourcing hubs in communicating with various suppliers to get submission documents for both New Product Development (NPD) and commercial sources.
13. Assist in specifications revisions (monograph updates or new project status), as well as industry initiatives, coordinating between Apotex and the suppliers.
14. Assist Global API Technical (GAPIT) Managers in the sourcing of API manufacturers for new product development and commercial projects.
15. Represent Global API Technical (GAPIT) as requested by Apotex internal groups regarding issues pertaining to API, so that these problems can be efficiently addressed with the supplier.
16. Assist Apotex’s alternate sourcing and supplier driven changes (SDC program) by participating in the API Performance Improvement Team meetings to resolve any technical or quality related issues and communicating these issues to the suppliers as necessary.
17. Maintain New Product Development (NPD and alternate source database and API comparison tables.
18. Lead or participate in initiatives for the improvement of internal processes that affect API supplier qualification or API release (e.g. SOP, sharing of data, methods and specification development, OOS investigation processes etc.).
19. Coach and assist other groups on API technical matters as required.
20. Works as a member of a team to achieve all outcomes.
21. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
22. Performs all work in accordance with all established regulatory and compliance and safety requirements.
23. Performs all other tasks and duties as may, from time to time, be assigned (e.g., confidentiality disclosure agreements).
Job Requirements:
? M.Sc., B.Sc. or B. Eng. in Chemistry or Chemical Engineering, Pharmaceutical or Health Sciences required.
? 5-10 years of experience in the pharmaceutical industry is required.
? Must have API plant manufacturing and process control experience along with milling, powder processing and unit operations involved in the manufacture of an API.
? Must have experience with analytical testing of API and drug product with hands on experience with HPLC, GC, and Malvern.
? Must possess knowledge of the technical, quality, and regulatory issues related to the qualifying of a drug substance.
? Must possess the ability to provide explanations or solutions to a variety of problems of moderate scope and complexity.
? Ability to read and interpret complex technical documents. Ability to write detailed business correspondence.
? Ability to work with managers or directors and communicate ambiguous concepts.
? Excellent communication and interpersonal skills.
? Strong organizational skills; ability to work independently and manage priorities
? Demonstrated knowledge of the generic new product development process.
? Knowledge of and experience with the MS-Office suite of products; with particular emphasis on MS-Word, MS Outlook and MS-Excel.
职能类别： 生物工程/生物制药
公司介绍
奥贝泰克药物化学（天津）有限公司是加拿大 Apotex Inc.独资在中国建立的公司，是一个具有国际先进水平的医药原料药研发、中试和小批量生产中心。公司高度重视研发，相信技术是企业发展的推动力，愿为有志在制药行业发展的有机合成，化学工程，药物分析，药物化学，国际贸易等方面的人才提供展现你才能的舞台。
报名方式：
应聘职位人员请在信封上注明应聘职位并将中英文简历，各种能力证书复印件，身份证复印件，联系方式及近照一张寄至：
天津经济技术开发区海星街19号
奥贝泰克药物化学（天津）有限公司 人力资源部
邮编：300457
E-mail ：zhaopin@apotexpharmachemchina.com
报名方式：
应聘职位人员请在信封上注明应聘职位并将中英文简历，各种能力证书复印件，身份证复印件，联系方式及近照一张寄至：
天津经济技术开发区海星街19号
奥贝泰克药物化学（天津）有限公司 人力资源部
邮编：300457
E-mail ：zhaopin@apotexpharmachemchina.com
联系方式
- Email：zhaopin@apotexpharmachemchina.com
- 公司地址：地址：span天津市经济技术开发区海星街19号