A listed pioneering biotechnology company.
MAIN DUTES AND RESPONSIBILITIES
1.Responsible for formulation design and development of clinical development candidates.
2.Serve as drug product Project Leader to program teams for programs from early development through registration.
3.Choose, oversee and manage CROs and CDMOs to ensure timely execution of high-quality deliverables in accordance with safety and compliance requirements and regulatory commitments.
4.Interface on the establishment of product specifications, applying stage-appropriate and risk based approach.
5.Provide input on program development strategies, budgets, and timelines to ensure that both technical and business requirements are achieved.
6.Build and maintain strong working relationships with relevant internal Development and Discovery functions to effectively support on-going programs.
7.CMC reviewer for formulation and drug product regulatory submissions .
SKILLS
1.MS with 8+ years or PhD with 5+ years of industrial experience
2.Extensive experience in compound profiling, formulation design, process development, and analytical characterization of small molecules.
3.Knowledge of cGMP compliance, FDA and ICH guidelines and other regulatory requirements.
4.Excellent management and interpersonal skills coupled with goal-oriented personality.
5.Excellent communication, problem-solving skills.
6.Good written and oral communication skills in English.
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