Formulation Development Director/ Senior Director Job Location: Contact Us: ,

Key Responsibilities:

  • Responsible for formulation research activities, including process design and optimization, quality and stability standard, and ensuring smooth tech transfers for larger scale productions to support early stage clinical study.

  • Provide constructive guidance in pharmaceutical formulation/analytical work; Coordinate the activities of product evaluation, stability study, method development and validation to establish specifications for raw materials and finished dosage forms.

  • Following IND guidelines, draft and review the application materials, support application to major authorities including NMPA, USFDA, EMA etc

  • As key team member of CMC team, coordinate/cooperate API, DS and analysis development, ensure smooth teamwork;

  • During preclinical development, Assessment of NCE developability and formulation feasibility, enable necessary pre-formulation to support toxicology studies;

  • Work with pre-clinical and clinical teams to design, evaluate and improve CMC strategies to align on clinical development plan

  • Based on chemical characteristics, pharmacology, and pre-clinical study data of the drug, design, test and improve an initial clinical drug formulation for IND application and early phase clinical studies

  • Based on a specific CMC strategy, ensure qualitysufficient and timely manufacture of drug supplies and coordinate drug shipment for early phase clinical studies 

  • Assist in plant location selection & facility design with constructive suggestions;




Education or Experience : 

  • Ph. D. in Chemistry, Pharmacology or related field

  • At least 8-10 years R&D experience in pharmaceutical company or CRO company in related field;

  • Familiar with formulation activities for early stage development;

  • Familiar with FDA/EMA/NMPA guidelines, related industrial standards (eg., ICH, USP, ChP) and pharmaceutical R&D process;

  • Track record of successful formulation and/or production


Knowledge and skills: 

  • Strong problem-solving skills, professional technical capabilities and outstanding leadership skills;

  • Ownership, proactive attitude, good communication skill and strong learning ability



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