sapa-neweb.org Kelun... · Web viewAssist general manager in operations in USA and direct new cGMP workshop planning and construction or renovate existing workshop in China and ensure

美国科伦药业有限公司 US Kelun

Pharmaceutical Co., Ltd.

Talent Recruitment (USA)

VP/Director –cGMP Manufacturing/ Quality AssuranceLocation, New Jersey/China, USA

Responsibility: Assist general manager in operations in USA and direct new cGMP workshop planning and

construction or renovate existing workshop in China and ensure these workshops compliance to the FDA drug manufacturing regulations (21 CFR Part 210, 21 CFR Part 211) and guidelines, site SOPs, protocols, and industry standards / CGMPs, as applicable.

Responsible for directing technical transfer, scale up and FDA onsite inspection activities. Responsible for directing quality assurance (GMP QA) activities for sterile generic injectable

product development, manufacturing and commercial product launch.

Requirements: Min. Bachelor’s degree in pharmaceutical science or related field required. Minimum of 10 years’ generic sterile injectable pharmaceutical experience in the FDA

international inspection prefer in China, manufacturing, scale up, technical transfer, quality assurance, audit, project management and regulatory compliance.

Expert knowledge of FDA, ICH cGMP requirements regarding cGMP (new manufacturing workshop and renovate existing workshop, generic sterile injectable product development, technical transfer, and manufacturing and ANDA submission).

Strong knowledge and understanding of the approach and perspectives of regulatory agencies. Must be able to interpret and apply CGMP regulations and guidance independently. Excellent writing, communication and presentation skills. Demonstrated leadership and project management skills.

US Kelun Pharmaceutical Co., Ltd.Talent Recruitment (USA)

cGMP 生产/ 质量保证总监/副总经理工作地点: 美国新泽西州/中国

职位描述协助总经理在美国公司工作,负责中国新建 cGMP 厂房规划建设或改造现有厂房，并确保

这些厂房符合 FDA 的药品生产法规（21 CFR 第 210 的 21 CFR Part211）及指导原则,

生产所在地的标准操作规程，协议和行业标准/cGMP。负责指导技术转移，工艺放大和中国厂房 FDA 现场检查。负责无菌注射仿制产品的研发，注册批生产及药品商业化生产的质量保证。

职位要求最低医药科学或相关专业本科学历。至少有 10 年无菌注射剂仿制药物经验，FDA 现场检查经验，最好有在中国 FDA 现场检

查经验、药品生产、工艺放大、技术转移、质量保证、审计、项目管理和法规执行经验。有丰富的 FDA、ICH 及 cGMP 的专业知识，及有关的 cGMP（新的生产车间和改造现有

厂房，一般无菌注射产品开发，技术转移，生产和 ANDA 注册报批）的工作知识。有很强跟监管机构打交道工作的知识及理解能力。.

必须能够独立解释和应用 CGMP 法规及指导原则。

If interested, please send your resume to: [email protected]/[email protected]: 86-28-67255175; 217-853-0067

mailto:[email protected]


具有优秀的写作，沟通和表达能力。具有优秀的领导能力和项目管理能力。




Director -Formulation DevelopmentLocation, New Jersey, USA

ResponsibilityDirect and manage formulation team to develop generic sterile injectable products including formulation & process development, scale up, technical transfer, exhibit batch manufacturing, ANDA submission, FDA deficiency response and commercial product launch.

Requirements BS with at least 10 years, MS or Ph.D. level with at least 8 years of recent pharma industry

formulation development, project management, manufacturing, ANDA, QBD experience with sterile injectables including lyophilization products.

Previous successful management experience is required. Expertise in cGMPs, Regulatory and ICH guidelines / requirements, FDA guidelines and ANDA

submission documentation. Excellent Communication skills Experience in suspension products desired. Ability to motivate and mentor other scientists.

制剂配方研究部主任工作地点: 美国新泽西州

职责描述负责指导和管理配方研究团队，从事无菌注射剂仿制药品研发，包括配方及工艺的研发，

工艺放大，技术转移，注册批生产，ANDA 申报文件准备提交，FDA 缺陷信回复及药品的商业化生产。

职责要求具有学士学位，至少 10 年，硕士或博士学位至少 8 年最新制药行业无菌注射剂仿制药物，

包括冻干产品的配方研发，项目管理，药品生产，ANDA 文件申报及 QBD 药品开发经验。If interested, please send your resume to: [email protected]/[email protected]: 86-28-67255175; 217-853-0067



具有成功的团队管理经验。有丰富的 cGMP，注册法规和 ICH 指导原则/要求，FDA 的指导原则和 ANDA 申报的知识。

有良好的沟通技巧希望有混悬产品开发的经验。能够激励并指导其他科学家。

Director- Analytical DevelopmentLocation, New Jersey, USA

ResponsibilityResponsible for technical and operational leadership for Analytical Development team involved in generic sterile injectable product analytical development activities for successful exhibit batches and for timely FDA submissions with minimal deficiencies. Responsible for successful outcomes in developing and validating analytical methods, as well as stability and formulation testing, necessary to support the goals and objectives of generic sterile injectable product development.

Requirement PhD with no less than 10 years related sterile injectable analytical development experience of

increasing responsibilities within a pharmaceutical setting, or BS/MS with more than 15 years of the same.

Experience to include analytical development and validation, performance and coordination of stability studies, troubleshooting, and responding to non-standard corporate needs.

Previous successful management and project management experience is required. Proven outstanding communication and collaborative skills.

制剂分析研发部主任工作地点: 美国新泽西州

职责描述




负责制剂分析研发团队技术及日常操作,从事无菌注射剂仿制药品分析方法研发，以最少的缺陷,确保注册批成功生产及向 FDA 及时申报.开发并验证分析方法，进行稳定性和配方研究的的检测，支持无菌注射仿制药品研发的目标和目的。

职位要求生命科学或化学博士有至少 10 年以上，或生命科学或化学本科及硕士，拥有超过 15 年

的职责逐渐增加环境的无菌注射分析开发经验。有丰富的分析方法开发及验证经验，仪器操作, 稳定性实验的协调，故障排除和及时应对

非标企业的需求经验。具有先前的成功团队管理和项目管理经验。具有经过实践检验的优秀的沟通和协作能力。

Formulation ScientistLocation: New Jersey, USA

Responsibility Formulation development of generic sterile injectable including lyophilizationdrugs. ANDA project handling with Regulatory documentation for ANDA submissions. Formulation, Stability Study as per ICH guidelines, and technology transfer and scale-up.

Requirements BS, MS and PhD. in pharmaceutical science, Chemical or Life Sciences. 2 - 6 years of related sterile injectable generic formulation, ANDA, OBD experience in a

pharmaceutical environment. Demonstrated abilities in the areas of formulation development in injectable including

lyophilization with manufacturing experience.




Experience in suspension products desired. Excellent communication skills (verbal and technical), interpersonal skills, and problem-solving

skills.

制剂配方科学家工作地点：美国新泽西州

职责描述从事仿制无菌注射剂包括冻干药品的配方工艺开发研究, 技术转移, 放大及注册批生产.

准备仿制无菌注射剂 ANDA 报批文件.

按照 ICH 指南从事配方稳定性研究.

职位要求医药学，化学和生命科学本科，硕士和博士。 2-6 年的相关医药仿制无菌注射剂，ANDA 文件报批，QBD 的配方研究经验。有很强的配方研制和注射（及冻干）产品生产经验的实际工作能力。希望有混悬产品开发的经验。优秀的沟通能力（口头和技术），人际交往能力和解决问题的能力。

Analytical ScientistLocation: New Jersey, USA




ResponsibilityResponsible for analytical methods development for ANDA liquid, powder fill and lyophilized aseptic injectable products. Develop and validate new analytical methods, conduct stability studies and perform sample testing to support regulatory submissions.Requirements BS, MS /PhD. level in Life Sciences or Chemistry and have five to seven years’ experience in

analytical methods development in a small molecule product environment. Must be knowledgeable in a broad range of instrumentation including HPLC, GC, Ion

Chromatography and Mass Spectrometry. Experience with analytical method development and reverse engineering for suspension products

desired. Excellent communication skills (verbal and technical), interpersonal skills, and problem-solving

skills.

制剂分析科学家工作地点: 美国新泽西州

职责描述负责仿制水针,粉末灌装和无菌冻干注射产品分析方法研究. 开发和验证新的分析方法，进

行稳定性研究，并进行抽样检验，以支持药品注册报批。

职位要求生命科学和化学的本科，硕士/博士, 并有五至七年“的小分子化学药品分析方法开发经验。

必须了解各种仪器，包括液相色谱，气相色谱，离子色谱法和质谱法。希望有混悬产品分析方法的开发及配方解析的经验。优秀的沟通能力（口头和技术），人际交往能力和解决问题的能力。If interested, please send your resume to: [email protected]/[email protected]: 86-28-67255175; 217-853-0067



Director, Quality AssuranceLocation: New Jersey, USA

ResponsibilityResponsible for cGMP compliance ensuring all FDA regulations, guides, ICH, ISO and other regulatory requirements are adhered to. Ensure all generic sterile injectable products development, manufactured, processed, packed or held meet requirements for product identity, strength, quality, and purity, including products for regulatory submission.

Requirements Bachelor’s degree (BS) from four year college or university with at least 10+ years industry

experience and (5) years related managerial experience in the pharmaceutical industry with extensive knowledge of quality management techniques and systems.

Must have cGMP, QA experience in a FDA related environment, inclusive of 21 CFR Part 11 compliance criteria.

Expert knowledge of FDA, ICH, cGMP requirements regarding new manufacturing workshop and renovate existing workshop, generic sterile injectable product development, technical transfer, and manufacturing and ANDA submission).

Excellent writing, communication and presentation skills.

质量保证主任工作地点:美国新泽西州

职责描述确保符合 cGMP 要求.确保所有的 FDA 法规，指南，准则，ICH，ISO 和其他监管规定得

到遵守。确保所有通用的无菌注射产品的研发，生产，加工，包装符合产品标识，规格,，质量和纯度，包括产品的注册报批。




职位要求本科,至少有 10 年以上的医药工业相关经验和 5 年以上相关管理经验,有丰富的医药行业

的质量保证,质量管理及质量系统的知识。必须有 cGMP 及在 FDA 的相关环境质量保证的经验，其中包括 21 CFR Part 11 的符合性

规范。有丰富的 FDA,ICH 及 cGMP 的专业知识，及有关的 cGMP（新的生产车间和改造现有厂

房，一般无菌注射产品开发，技术转移，生产和递交 ANDA）的工作知识。优秀的写作，沟通和表达能力。

Microbiologist Location: New Jersey, USA

ResponsibilityResponsible for microbiological method development for generic sterile injectable products including Bioburden, AET, endotoxin, BRT and sterility testing etc. and adhere to cGMP laboratory procedures according to FDA guidance.

Requirements Must have a BS in Microbiology, Biology, Biochemistry or related science with more than 5

years sterile injectables microbiological development experience. Extensive understanding of cGMP, ICH and FDA guidelines and ANDA submission

documentation. Excellent communication (verbal and technical) skills.

微生物学家工作地点: 美国新泽西州 If interested, please send your resume to: [email protected]/[email protected]: 86-28-67255175; 217-853-0067



职责描述根据 FDA 的要求，遵守 cGMP 的实验室操作规程,负责无菌注射仿制新药品微生物方法

开发,验证，包括生物负载检测，AET，内毒素，BRT 和无菌试验等。

职位要求至少微生物学，生物学，生物化学相关的本科及有 5 年以上的无菌注射剂的微生物方法

开发经验。有丰富的 cGMP，ICH 和 FDA 及仿制药注册报批知识。优秀的沟通（口头和技术）能力。

Purchasing SpecialistLocation: New Jersey, USA

ResponsibilityPrimarily responsible for providing day-to-day procurement functions and operations across all product categories such as API ,excipients, packaging components, filters etc. to meet product development, exhibit batch manufacturing, ANDA stability requirements according to FDA/CGMP requirement.Requirements




Bachelor’s degree or equivalent combination of education and experience. Min. 5 years of experience in purchasing of pharmaceuticals API, excipient, package components

for generic sterile injectable products. Good knowledge of FDA, ICH and cGMP requirements Excellent communication skills.

采购专员工作地点：美国新泽西州

职责描述主要负责提供每天的日常采购，如 API，辅料，包装物，过滤器等，以满足产品研发，注册批生产,仿制药稳定性实验符合 FDA/ CGMP 要求.

职位要求相关大学本科学历。最少有 5 年的仿制无菌注射产品药品的原料,辅料及包装材料的采购经验。良好的 FDA，ICH 和 cGMP 的知识。优秀的沟通技巧。

Human Resources SpecialistLocation: New Jersey, USA




Responsibility To maintain all necessary and appropriate employee records and documents by maintaining a filing and retrieval system, keeping past and current records; to provide information and communicate to all employees regarding company payroll/personnel policies and benefits; to administer all company benefit plans, and act as the primary liaison between the company and benefit plan providers.

Requirements

A Bachelor’s degree in an HR related field preferred. Advanced HR generalist skills including employee relations, benefits management, HRIS, compensation, performance management and Federal contract compliance. At least 2 years of related HR generalist experience ideally in a pharmaceutical environment. Demonstrated thorough understanding of company personnel and benefit policies. Excellent written and verbal communication skills. The ability to communicate with all levels of the organization, including the executive level. Fluent in Mandarin and English preferred.

人力资源专员工作地点：美国新泽西州

职责描述负责公司人事管理, 通过保持归档和恢复系统,维护所有必要和适当的员工记录和文件,保持过去和现在的记录;提供公司的工资单/人事政策和利益;管理公司所有的福利计划信息和传达给所有员工,并作为公司与福利计划供应商之间的主要联络人。

职位要求 •有人力资源相关专业学士学位者优先。 •高级人力资源通才技能，包括员工关系，福利管理，人力资源信息系统，薪酬，绩效管理和联邦合同合规If interested, please send your resume to: [email protected]/[email protected]: 86-28-67255175; 217-853-0067



性。 •至少 2 年以上制药环境相关人力资源经验。 •透彻的了解公司的人事和福利政策。 •优秀的书面和口头沟通能力。•与各级组织，包括行政级别进行沟通的能力。 •流利的普通话和英语者优先。

Business Development Manager

Responsibility

Looking for new drug and new project t opportunities in North America; Looking for acquisition opportunities in corporate investment and joint ventures in North America; North American pharmaceutical market research and pre-drug sales channel development, including the selection of strategic partnership marketing and sales partner. Other matters related to business development with the North American target market of pharmaceutical industries. Requirements

A Bachelor or Master’s degree in an Business Development related field preferred. Extensive knowledge of the pharmaceutical market Consolidated professional experience

in the sales and marketing areas More than 5 years successful professional experience in companies of generic drugs and

API . Powerful personality, initiative, result-oriented approach and excellent relational skills

商务开发经理工作地点：美国新泽西州

职责描述寻找新的药物和北美的新项目合作的机会 ;寻找企业投资，在北美的合资企业的并购机会 ;北美医药市场调研和药品销售渠道的开发，其中包括战略合作伙伴关系的营销和销售合作伙伴的选择。北美制药行业市场有关的与业务发展相关的其他事项。

职位要求If interested, please send your resume to: [email protected]/[email protected]: 86-28-67255175; 217-853-0067



•有业务发展相关专业大学本科或硕士优先。 •有丰富的医药市场知识及销售和营销方面的专业经验 •有 5 年以上成功的仿制药和原料药北美商务开发经验 •具有强大的个性，主动性,以结果为导向的方法和出色的关系型技能.

科伦药物研究院创新药物药效研究总监虚位以待科伦集团创立于 1996 年，是拥有省内外 87 家子(分)公司的现代化药业集团。2013 年

科伦集团营业收入超过 350亿元，利税超过 20亿元人民币。科伦药物研究院致力于抗肿瘤抗病毒（HBV）、精神及神经系统疾病、糖尿病治疗药物以及适宜公司发展的专科用药等化学和生物技术仿制与创新药物的研究。科伦药物研究院总部位于成都，同时正在建设北方（天津）、南方（苏州）和美国的药物研究分院；现有研发人员 395 人，其中，博士 38 人现需招聘创新药物药效研究总监。招聘职位：创新药物药效研究总监工作地点：四川·成都工作职责：1. 负责建立小分子创新药物的体内外药效研究能力，完成其筛选和药效研究，并与临床研究

团队共同完成相应的临床研究；2. 负责组织创新药物申报材料以及选题立项、引进项目评估。任职要求：1.学历要求：博士学历；2.专业要求：临床医学、生物学、药学或相关专业；3.工作经验：具备 8 年以上的创新药物的筛选和药效研究经验，并在研发过程中担任主要项目负责人，有产品进入申报或临床阶段，有肿瘤领域创新药研发经验者优先考虑；4.能力要求：If interested, please send your resume to: [email protected]/[email protected]: 86-28-67255175; 217-853-0067



1) 具有丰富的新药研发经验；熟悉完整的创新药物研发流程，了解临床报批内容及程序；2) 非常熟悉国内外创新药研发的指导原则、药政法规以及国内外创新药研发动态； 3) 具有丰富的研发团队管理和培养经验；4) 具有高度的责任感和敬业精神；5) 具有药效、药代、安全性评价全局性的综合评价能力或衔接临床试验能力及曾在海外制

药公司担任 Project leader者优先考虑。5.语言要求：具备较强的外文阅读能力和书写能力，具备较强的文字表达能力。符合条件者待遇从优。有意者请联系：科伦药物研究院人力资源部 [email protected] 028-67255175




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sapa-neweb.org Kelun... · Web viewAssist general manager in operations in USA and direct new cGMP workshop planning and construction or renovate existing workshop in China and ensure