JD基本信息
岗位职责
Job Responsibilities:
As a leader of QC FL team, the responsibilities include but not limited to:
1. Resource Planning, Hiring, Training and Career Development and talent retain
2. Department Strategic Planning, formulating Key Performance Indicators & Action Plans
3. Lead QCFL team to work with QC testing team and other function department like PL analytical science team, manufacturing team and Quality assurance team to delivery all activities related to QC with high quality and meet project timeline
4. Continuously improve and optimized QC project management workflow to maximize potential for successful execution of projects
5. Set and manage client expectations
6. Define and document project scope, objectives, and desired outcome related to QC.
7. Manage the team to ensure all project activities are delivered with high quality and meet project timeline
任职要求
Job Requirements:
1. Mater and above in Analytical Chemistry, Chemistry, Biochemistry, Biology, Pharmaceutical, or related field.
2. 8+ years of pharmaceutical industry including NLT 3 years team and project management experience (project management experience for late stage is preferred).
3. Knowledge of small molecule pharmaceutical analysis technology (3+ years of experience in analytical development and 3+ experience in QC is preferred) and familiar with small molecule production and quality system.
4. Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas.
5. Critical thinking, scientific reasoning and problem-solving skills. Familiar with Statistical analysis.
6. Strong communication skills in English and Chinese, fluent in speaking, writing and reading in both languages.
7. Experience in small molecule CDMO industry is preferred.