ASAT理化主管

Job Responsibilities:

· Provide technical analytical expertise and guidance on physicochemical laboratory investigations with GMP standards and in accordance with relevant industry guidelines

· Conduct physicochemical analytical technology transfer projects and support CMOs/ new sites during the whole onboarding process, tech transfer, and routine production

· Provide physicochemical analytical technical support and conduct problem-solving activities during technology transfer and routine production.

· Provide support for troubleshooting and continuous improvement in the physicochemical laboratory, and support inspections and quality audits

· Support the ongoing product development and regulatory submission (BLA/MAA) of our Protein-based therapeutic pipeline; and act as physicochemical analytical SME with expert knowledge to regulatory filings and questions from health authorities

· Participate in the creation/revision and approval of AS&T-owned Standard Operating Procedures (SOPs), work instructions, technical documentation package and other supporting documents

· Supporting the evaluation and implementation of new physicochemical technologies required to maintain state-of-the-art analytical methods for development in alignment with internal and external stakeholders

· Establish physicochemical analytical methods.

· Establish a physicochemical platform methods with reference to the pharmacopoeia of various countries and regulatory guidance.

· Complete other tasks assigned by the leader.

Requirements:

· Bachelor degree or above (preferably 985, 211 colleges), major in biochemistry, bioanalysis, analytical chemistry and other related majors.

· More than 4 years of relevant work experience in GMP biopharmaceutical enterprises.

· Rich experience in analysis and quality control in the pharmaceutical industry; Experience in physicochemical methods including but not limited to various HPLC- and capillary-based analytical methods.

· Familiar with the global regulations (ICH, NMPA, FDA, EMA, USP, ChP, EP) for quality control and have certain understanding of GMP requirements.

· Familiar with the relevant instruments, method developments and method validations of biologics.

· Strong independent thinking and analytical skills, able to provide solutions according to the actual situation.

· Good project management ability, good communication skills, and good team spirit.

· Good English listening, speaking, reading and writing skills.