Head/ Director, Formulation and Drug Product Development
Reports to : Head of Technical Operation
Scientist, Preclinical
Head of R&D
Objectives
The Individual will be involved in driving the development of Hilleman Laboratories pipeline products (including vaccines, mAbs, recombinant proteins). Responsibilities include managing both the Formulation and Drug Product development teams in Sinagpore and India. The individual will formulate the strategies for formulation and drug product development efforts within Hilleman Laboratories.
Responsibilities
Oversee a team responsible for formulation and drug product development for
Recombinant protein, Mab and vaccines portfolio for process scale-up and manufacturing for clinical trials
Influence product selection and advancement of developmental candidates that can meet theTarget Product Profile and preferred product presentation
Establish and maintain close collaboration with counterparts across Process Development, Analytical Development, Quality, Regulatory, Clinical Supply Manufacturing
Drive alignment of drug product development practices and initiatives across sites and phases of development
Identify and implement innovative solutions and technologies to resolve complex problems and drive continuous improvement in drug product development.
Manage a high performing team and provide creative strategies to maximize team engagement and ensure team reaches full potential.
Serve as member of the CMC leadership team and extended Process Development leadership team utilizing network thinking and innovative approaches to advance the drug product organizational capabilities
Education, Behavioural Competencies And Skills
Doctorate Degree & 10 years of Pharmaceutics, Formulation or Process Development experience OR
Master’s Degree & 12 years of Pharmaceutics, Formulation or Drug Product Development experience OR
Bachelor’s Degree & 16 years of Pharmaceutics, Formulation or Process Development experience AND
6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferably Ph.D. or equivalent in Biochemistry, Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related major and 14+ years of relevant experience in the pharmaceutical or related industry which includes leadership of scientific project teams and successful leadership of drug product project groups
Direct experience with formulation and drug product process development
Understanding and applied knowledge of regulatory requirements for the pharmaceutical industry (e.g. FDA, ICH, and USP guidelines)
Knowledge of pharmaceutical science, analytical chemistry, and protein stability
Knowledge of process development of drug product in vaccines and Mabs
Knowledge of drug product process scale-up and aseptic manufacturing