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Principle Associate/Scientist - Shanghai, 中国 - Roche
描述
The Position
Primary Purpose of Job (Job Summary)
Provide technical expert to support the process development and formulation development in CMC setting; Play key roles in coordinating analytics related activities cross functions, between global and local, as well as with external partners.
Principal Roles & Responsibilities / Accountabilities
(Major functions of the position)
-- Represent the analytics at cross-functional project teams. Lead analytical activates to support programs from late phase discovery to early clinical development.
-- Perform analytical method development (such as assay/impurity, chiral purity, etc.), release testing, impurity identification to support API process development.
-- Evaluating the physiochemical properties of API and DP such as particle size, dissolution, content uniformity, etc. to support solid oral drug product.
-- Specifications setting for both API and drug product with justifications
-- Author analytical related documents including test protocol, method validation protocol/report, method transfer protocol, stability protocol/report and release CoA, etc.
-- Manage collaborations with CRO/CMO for outsourcing activities. Oversee analytical method development, validation, release testing, and stability study carried out at CRO/CMO.
-- Prepare the analytical sections of documents for DS/ DP to support regulatory degree in analytical chemistry or closely related field with > 2 years' working experience in pharmaceutical industry, or Master degree in analytical chemistry or closely related field with at least 5-10 years' working experience in pharmaceutical industry.
Leadership Competencies
Technical Expertise, Decision Making, Interacting and collaborate efficiently with cross function team, Independent problem solving skill.
Job Required Competencies
Solid knowledge on the state-of-the-art analytical theories and technologies, and hands-on experience in operating, calibrating, maintaining and troubleshooting of a wide range of analytical instruments (HPLC, GC, SFC, IC, LCMS, dissolution, etc.).
Proficient in analytical testing method development, validation, stability studies, and impurity identification, etc. to support both drug substance and drug product development.
Hands-on experience in dissolution method development and IVIVC modeling to support solid oral drug products is a plus
Familiar with ICH guidelines and good understanding of cGMP & GLP lab operation
Excellent written and communication skills in English and being able to work effectively with a diverse team of co-workers in a dynamic environment.
