About Company
My client provides single-source discovery, development and manufacturing services for antibody drug conjugates (ADCs) and other novel bioconjugates. This one-stop approach and the fact all services are within one-hour drive allows us to provide an unprecedented streamlined platform that cuts in half the time it takes to develop and manufacture these complex modalities.
Responsibilities
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Responsible for routine operation of QC lab, including but not limited to:
1. Manage the routine operation of QC metrology and digitalization group to ensure the business delivery at the right quality, cost and speed.
2. Manage several sub-teams like computer system management, QC DI group, equipment management and instrument management group.
3. Lead the team to comply with internal requirements in all aspects via end-to-end quality control system oversight.
4. Ensure all the activities in the team performed with compliance of cGMP, data integrity and EHS requirement.
5. Oversight of the training, evaluation and management of the staff in QC lab. Coaching, developing and supporting them in reaching their full potential.
6. Responsible for GMP audit from regulatory authorities and clients. Reply to audit reports and create CAPAs.
Requirements
1.Bachelor degree or above in pharmacy, chemistry, biochemistry, analytical chemistry or other related discipline;
2.At least 8 years relevant working experiences in biotech or biopharma companies, including 5+ years of team management experiences;
3.A good understanding of the overall view of drug development process.
4.A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.
5.Comprehensive knowledge in FDA, EMA, NMPA, ICH, WHO technical guideline and USP, Eur.P, ChP pharmacopoieas.
6.Comprehensive knowledge in IND/IMPD, NDA and ANDA filing
7.English can be as working language.
