Responsibilities

Provide technical support for NCE formulation development and production for early phase clinical studies.

Interface with CRO partners, suppliers and clients and communicate effectively with external partners. Internally efficiently communicate with multi functions/stakeholders to make sure the formulation/DP work/their importance is understood, supported and highlighted.

Provide technical support of preclinical formulation development for PK, PD, Tox and other drug assessment studies.

Technical support of NCE developability assessment.

Design/review protocol with CRO, conduct early phase formulation development including conventional and enabling formulation, liquid and solid oral formulations.

Execute late phase formulation and process development employing DoE to achieve the quality by design.

Lead tech transfer, scale up, validation and drug product launch in clinical manufacturing site and/or commercial site in CRO/CMO or own sites.

Overseeing GMP manufacturing activities in CRO to make sure of the clinical supplies in different phase e.g. I, II, III, in quality, in quantity, on time, and within budget.

Skillset:

Ms/PhD in Pharmaceutical Sciences, Pharmaceutical or related field with at least 3-8 years of experience.

Solid knowledge in drug product formulation development and manufacturing.

Deep understanding on the pre-formulation data sets to support on formulation design.

Experience in new drug formulation development, e.g. enabling formulation e.g. ASD (amorphous spray dried), hot melt extrusion, nano sizing, emulsion, liquid capsules, etc.

Experience in conventional formulation and manufacturing process development, e.g. capsules, tablet, dry granulation, high shear wet granulation, fluid bed granulation, etc.

Experience in design and review on drug product manufacture/packaging/labeling batch records

Extra experience in pre-formulation (salt and polymorph, and solid state characterization)/API crystallization and particle size engineering, is much preferred.

Experience in modified release formulation development is the plus.

Experience in in pharmaceutical analysis/regulatory affairs is the plus.

上班地址：亮景路199号