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  • Manager, Formulation Development

    Posted 25 Jan 2023|Full time|PD-FD

    Essential Functions of the Job:

    Manage team of scientists and technicians to complete 1-3 formulation projects in parallel approximately every six months;

    Develop and improve methodologies and technologies relating to protein formulation (focus on MAbs) including standard protocols based on product category;

    Develop and improve methodologies and technologies relating to protein formulation for intermediates, drug substance and drug products including standard protocols based on product category;

    Characterize processes sufficiently for Phase I through to BLA;

    Author protocols, reports, technology transfer protocols/reports and other technical documents (i.e. Master Formula, specifications) as part of the product development and technology transfer process;

    Solves problems using multiple problem-solving tools and techniques as well as using appropriate resources, personal knowledge and experience with whatever data are available given the situation;

    Take responsibility of the general operation and maintenance of the protein formulation laboratory facilities;

    Manage annual department expenditure and project CAPEX in line with budget;

    Comply with Company Policies and Procedures and contribute positively to Company Morale; Plans, executes and manages both routine and non-routine projects simultaneously with general criteria for results;

    Other reasonably duties as requested by Company Senior Management from time to time.

    Education Required:

    Major in Pharmaceutics, Pharmaceutical Science or related field;

    Advanced post-graduate qualification (MSc or PhD) related to bioprocessing or biopharmaceutical production.

    Essential Experience:

    MS degree with a minimum of 3~4 years and Ph.D. degree with a minimum of 2~3 years of pharmaceutical formulation experience;

    Experience in managing staff of at least 2 technical specialists;

    Expert knowledge in protein biochemistry related to protein formulation and characterization of MAbs and recombinant proteins;

    Thorough practical knowledge of Chemistry Manufacturing and Controls for IND/CTA filing in China, USA and EU.

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