Essential Functions of the Job:

Lead and manage the Microbiological team for overall Microbiology activities in compliance with cGMP;

Promote collaboration and communication with other functional areas and clients to ensure timely completion of Microbiological activities to meet project timeline;

Develop training program. Ensure all staff receive training in basic cGMP training, applicable techniques and SOPs;

Lead the specification and procurement of equipment, start-up, commissioning and testing of Microbiological Laboratories for clinical and commercial biologic products;

Lead the technology transfer of Microbiological methods, testing protocols and etc.;

Manage the program of testing encompassing raw materials, environmental monitoring, critical utilities (e.g. WFI, PW, special gases, HVAC), intermediates, bulk drug substances, and drug products;

Provide technical support as the Subject Matter Expert (SME) level for guidance on test methods and procedures;

Initiate and review methods and procedures for completeness and accuracy;

Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

BS degree in Biochemistry, Microbiology, Immunology, Molecular/cell biology or a related discipline;

Essential Experience:

Minimum 5 years of QC relevant management experience in Anti-body/Bio-pharmaceutical/Vaccine industry;

Knowledge of standard requirements for plant facility monitoring and basic biological testing as stated by GB, CP, USP, EP, GMP;

Working knowledge and hands-on test experience in relevant industry;

Excellent communication skills (both verbal and written) and interpersonal skills are required. Fluent in English and Chinese.

Essential Functions of the Job:

Review calibration and maintenance activities and schedule needed, as well as arrange work within the team while coordinating with clients as needed;

Maintain calibration laboratory and/or departmental accreditation and quality systems. Perform laboratory and/or departmental administration and management;

Manage and perform and/or support method qualification and validation;

Create and review methods and procedures for completeness and accuracy;

Maintain testing equipment at a high level to quality to ensure accuracy and consistency of test results;

Responsible for documenting, computing, compiling, interpreting, reviewing, and entering data;

Responsible for the inventory management of all media and reagents used in QC testing;

Partner with Subject Matter Experts and/or take responsibility for the design of special project studies;

Ensure the timely disposal of tested samples and archive of retention samples;

Other reasonably duties as requested by Company Senior Management from time to time.

Education Required:

BSc (preferably Biology or Chemistry) or related life sciences degree.

Essential Experience:

Minimum 3 years of relevant experience in a cGMP QC operations for Analyst;

Solid experience in Biopharma/Pharma manufacturing and support equipment is essential.