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Ice@roche

新虫 (初入文坛)

应助: 0 (幼儿园)
帖子: 1
在线: 20分钟
虫号: 3916460
注册: 2015-06-09

[交流] Recruit Analytical Principle Associate - New Drug Early Discovery

具体工作地点:

Pudong, Shanghai

薪金:

Negotiable

学历和研究方向:

PhD or MS

招聘岗位:

Principle Associate

公司名称:

Roche

联系方式:

ice.zhang@roche.com

Job Description:

• Analytical method development & validation, in-process-control, starting materials quality control, intermediates and impurity profiling and identification, specification establishment, batch release testing, technical report & document preparation, etc..
• Provide analytical support to process and formulation
• Coordinate the technology transfer of analytical package and support the manufacturing of API and formulation externally.
• Identify and troubleshoot technical issues.
• Accurately record original data and be able to interpret and present the results.
• Write/co-author documents and scientific reports, including analytical development report in support of regulatory submissions.
• Collaborate closely with process chemist to establish specifications of IPC steps and final API release.
• Design and conduct the stability study for drug substance and drug product in accordance with established methods and specifications.
• Actively participate in analytical team efforts and contribute to technical evaluations and solutions.
• Train and coach junior analytical scientists.
• Maintain the proper operation of HPLC, LC-MS and GC-MS instruments and know some basic troubleshoot.

Job Requirements:

Education/Qualifications教育程度/所获资格证书
• Master degree in Pharmaceutical Analysis/Analytical Chemistry/Pharmaceutical Science or other related majors with at least 5 years’ working experience in pharmaceutical analysis or related area.
• Or Ph.D. degree with 1~2 years’ working experience in pharmaceutical analysis or related area.
Leadership Competencies领导者胜任力

Job Required Competencies岗位所需胜任力
• Solid knowledge on the state-of-the-art analytical technologies, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of instruments (HPLC, GC, LC-MS, GC-MS, UPLC, UPLC-MS, KF, UV, IR, PSD, Dissolution apparatus, etc.).
• Be proficient to analytical method development and validation for API and pre-clinical formulation release, stability study, in-process-control, quality control of starting materials and impurity profiling.
• Familiar with regulatory guidelines such as ICH, FDA, EMEA, and SFDA. Experience with protocol and report drafting and reviewing.
• Experience in analytical support for large molecules and peptides will be a plus.
• Good written and oral English are expected.
• Excellent communication, interpersonal skills and team-working ability is required.

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