Pre-formulation Development
和记黄埔医药有限公司ShanghaiUpdate time: July 23,2019
Job Description
Responsibilities:
? Manage Pre-formulation group, work closely with Process group and Formulation group to meet project timelines, departmental goals
? Plan, co-ordinate and oversee the work activities of Polymorph screening, Salt screening and selection, Solid state characterization (PXRD, TGA, DSC, Microscopy, etc.), Solubility determination, Particle size analysis, Recrystallization, pKa determination
? Support Process group to control particle size of API with recrystallization and milling.
? Support Formulation group to develop new formulations for poorly soluble compounds(such as nano-particles, solid dispersion, microemulsion) to improve bioavailability.
? Quick adapt to new technology and be a technical leader in certain areas
? Prepare document (Pre-formulation part) for IND and NDA filling
Basic Qualifications:
? Ph.D. (or equivalent) in Chemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field preferred.
? 8+ years’ experience in the pharmaceutical or biotech industry
? Strong technical knowledge of preformulation development. Working knowledge of process scale-up and technology transfer, cGMPs, ICH guidelines.
? Excellent interpersonal skills in internal and external (ie CMO/CRO management) interactions
? Excellent communication skills both written and oral
? Excellent time and project management skills
? Manage Pre-formulation group, work closely with Process group and Formulation group to meet project timelines, departmental goals
? Plan, co-ordinate and oversee the work activities of Polymorph screening, Salt screening and selection, Solid state characterization (PXRD, TGA, DSC, Microscopy, etc.), Solubility determination, Particle size analysis, Recrystallization, pKa determination
? Support Process group to control particle size of API with recrystallization and milling.
? Support Formulation group to develop new formulations for poorly soluble compounds(such as nano-particles, solid dispersion, microemulsion) to improve bioavailability.
? Quick adapt to new technology and be a technical leader in certain areas
? Prepare document (Pre-formulation part) for IND and NDA filling
Basic Qualifications:
? Ph.D. (or equivalent) in Chemistry, Pharmaceutical Sciences, Chemical Engineering or closely related field preferred.
? 8+ years’ experience in the pharmaceutical or biotech industry
? Strong technical knowledge of preformulation development. Working knowledge of process scale-up and technology transfer, cGMPs, ICH guidelines.
? Excellent interpersonal skills in internal and external (ie CMO/CRO management) interactions
? Excellent communication skills both written and oral
? Excellent time and project management skills
职能类别: 医药技术研发管理人员 医药技术研发人员
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上班地址:张江高科技园区哈雷路917弄4号楼
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