Head of Cmcb

1 week ago


Singapore PRESTIGE BIOPHARMA LIMITED Full time

**Job description**
- Overall in charge and management of CMCB resources including manpower and budget, operation, and drug development program
- Project management
- Regulatory submission oversight - Ensure that relevant sections of dossier filings are complete, well-presented, and in line with regulatory agency feedback and requirements to maximize the chance of approval. Where appropriate, make effective presentations to regulatory agencies regarding filings.
- Meet CMCB project, CMC and preclinical study’s milestones, goals and budget.
- Foster an environment consistent with PBPs values, including quality, clarity, performance awareness, and open communication.
- Mentor and develop managerial staff.
- Ensure that the activities of the CMCB department are traceable and operate efficiently.
- Drive therapeutic projects forward in a timely and efficient manner.
- Define and implement an optimally efficient group structure and workflow to archive scientific goals for drug development

**Educational/ Technical knowledge requirements
- PhD in Biomedical Sciences.
- 10+ years of experience as a research scientist, team leader, or project manager in various organization settings
- pharmaceutical R&D lab, academic research lab and contract research organization (CRO)
- Wide range of scientific and technical knowledge and skills such as immunology, cell biology, biochemistry, bioanalysis, bioassay, analytical chemistry, and pharmacokinetics and immunogenicity, pharmacology and pharmacodynamics
- Experience in GLP preclinical studies in field of toxicology, pharmacokinetics, bioanalysis (including method validation for PK, ADA and NAb), xenograft model, in vitro cytotoxicity and genotoxicity studies
- Experience in R&D lab setup and operation
- Experience in people management, people development and team building
- Experience in project management and cross-functional collaboration
- Experience in SOPs setup
- Equipped with in GLP and ISO17025 knowledge
- Practical experience in drug development and its various activities and requirement at different stages
- Knowledge on CMC and regulatory expectation
- Self-motivated, flexible, reliable and adaptable
- Good analytical, reasoning and critical thinking skills
- Good interpersonal and negotiation skills
- Good communication skills in English
- Good in scientific and technical writing
- MS-Office, statistical software and scientific software


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