Description
The formulation head is in charge of formulation department, for all preclinical and early clinical studies, and for all projects of the company.
The position also has key roles in coordinating formulation related activities between internal and external partners in China and abroad.
Principal Accountabilities
Are the group leader of the Formulation group and the project leader for formulation group
Supervise non-GMP and GMP manufacturing of solid and liquid formulations of NCEs at CMOs per project needs.
Represent formulation function at cross functional project team.
Provide critical feedbacks to project teams from formulation point of view.
Coordinate formulation activities both locally and globally with different stakeholders.
Provide interim and final deliverables within project timeline and budget requirements.
Is responsible for subordinates’ performance management and career developments.
Is responsible for maintaining a close relationship and interactions with academic and industry leaders in formulation areas.
Is responsible for publications and generating patents.
Is responsible for drafting good quality reports on time.
Is expected to review, edit, and offer critical feedbacks to the reports generated by subordinates.
Is responsible for establishing a safety culture in formulation group.
Is responsible for SOP drafting and trainings.
Accountabilities/Responsibilities
Ph.D. degree in pharmaceutics with at least 15 years (post graduate) of increasing responsibility and roles in small molecule (SM) formulation, ideally within both large pharma and biotech.
Strong hands-on experience in the area of formulation of SM NCEs in pharmaceutical solid/liquid dosage forms.
Rich R&D experience in preclinical and early clinical formulation.
Experience in setting up formulation lab and manage internal and external resources.
High level knowledge and understandings in regulatory guidelines such as ICH, FDA, EMEA, and SFDA.
Experience in formulation of large molecules and peptides is a plus.