• Provide guidance and hands-on assistance with biochemistry and molecular biology assays, including: column chromatography, proteomics techniques, PCR methods (extraction of residual DNA, primer design, quantitative PCR), mass spectrometric techniques and immunoassays etc.
• Plan, execute and interpret experiments on pre-clinical safety and efficacy studies.
• Lead a team in testing method development, and coordinate analytical support for technology transfer and method validation in a cross function matrix team environment.
• Maintain proficiency in the biological drug development process including a thorough understanding of the molecular attributes, target quality profiles and linking them to patient safety and efficacy aspects.

• PhD in Biology, Biochemistry, Biotechnology or equivalent discipline with minimum of 3 years experience in development of therapeuticprotein or 5 years experience in protein research.
• Understanding with hands on experience of analytical techniques using physical and biochemical characterization methods.
• Experience in drug safety and efficacy testing for protein drug development.
• Experience in drug substance and drug product manufacturing as well as method development, technology transfer and method validation preferred.
• Experience managing research associates and technicians.
• Adequate knowledge of regulatory guidelines related to biologic pharmaceutical development, characterization, and comparability including ICH guidance.
• Strong organizational, leadership, and managerial skills.
• Excellent trouble-shooting capabilities.
• Strong interpersonal and written and oral communication skills.
• Candidate with less experience will be considered as Assistant Manager
• Candidate with more experience will be considered as Senior Manager

• Develop and support strategic goals to assure corporate quality and regulatory compliance within the organization.
• Provides guidance on all areas of QMS that should fulfill the company’s Quality Policy and principles of Pharmaceutical Quality System.
• Manages projects to ensure compliance with increasing regulatory expectations for the manufacturing of Sterile Pharmaceutical Products and updated guidelines for validation and qualification activities.
• Bridge any product knowledge gaps between sites and corporate departments with regard to process and method alignments.
• Provides QA oversight and support to sites as required. Review applicable quality events, deviations, CAPAs, coordinate investigations and root cause analysis, as needed.
• Using a life-cycle approach, determines and establishes qualification/requalification, validation/re-validation requirements and frequency to meet Good Manufacturing Practices (GMP), company directives, and regulatory expectations.
• Ensures correct execution and implementation of all Validation Plans, Validation policy, standards and SOPs incorporating ICH Q9 Quality Risk Management.
• Provides validation assessments for GMP related changes as well as input related to product technology transfers to the facility.
• Ensures constant readiness and participate in regulatory audits for all aspects of Quality and Validation.
• Devises the plan and strategy to ensure GMP compliance to international standards.
• Develops and provides training on QMS, validation principles and any updated regulatory requirements.

• Bachelor Degree or above in relevant life science (eg. Pharmacy, Biomedical Science, Biopharmaceutics, Biochemistry, Biotechnology, Chemistry, Pharmaceutical Science).
• Experience in QA, QC, validation or R&D management in pharmaceutical or biotechnological industry is highly desirable.
• Working knowledge of cGMP and regulatory requirements of authorities including PIC/S, EMA, Health Canada, FDA, WHO.
• Proven track record of leadership, conflict management, early identification of potential GMP compliance issues and planning resolution strategies.
• Demonstrated project management skills to achieve timely goals and with experience of managing others in cross-functional teams to achieve corporate goals is high desirable.
• Excellent communication / interpersonal skills at all levels. Strive to cultivate quality culture in existing and newly established Sterile GMP Manufacturing facilities globally.
• Highly qualified candidates may be considered as Senior Manager.

• Tissue culture
• Molecular mechanistic studies, e.g. qPCR, IHC, WB, ELISA, etc
• Animal studies
• FFPE & Cryosectioning
• Data analysis
• Other duties assigned by management

• M.Phil. or Ph.D. graduates in Life Sciences, Biochemistry, Biotechnology, Biology or related disciplines
• At least 2 years of working experience in related research lab
• Expertise in molecular biology
• Experience in oligotherapeutic research is preferred
• Good interpersonal and communications skills
• Good command of spoken and written English and Chinese
• Candidate with less experience will be considered as Senior Research Technician

l

• After proper training, he/she will assist in the production of protein biologics for different research purposes including process development and various research studies.
• Perform characterization / QC tests for the in-process materials and finished product.
• Conduct literature search and report updates in regular meeting.
• Maintaining the daily operation of the research laboratory.

• BSc or MPhil in Biochemistry, Biological Chemistry, Biology, Biotechnology, Chemistry, Material Science, Polymer Science or other life science fields.
• Preferably with scientific Research and Development background and hands-on wet lab experience.
• Understanding of the aseptic techniques would be a plus.
• Self-motivated, organized, detailed-oriented, independent and enthusiastic.
• Have a can-do attitude and strong sense of team spirit.
• Proficiency in spoken and written English and Chinese.
• Fresh graduate welcome.
• Candidate with more experience will be considered as Senior Research Technician.

• Perform protein characterization tests, chemical analysis, routine animal measurements, dosing and assessment.
• Conduct laboratory report, data analysis and presentation.
• Report to team leaders on experimental set up and data analysis.

• Bachelor or MPhil in Biochemistry, Chemistry, Biotechnology or other related fields.
• Hands-on experience with protein and chemical analysis, animal handling and injection.
• Knowledge in IHC and cell culture is an advantage.
• Strong analytical, problem-solving, communication and inter-personal skills.
• Proficiency in spoken and written English & Chinese.
• Good command in Putonghua is an advantage.
• Fresh graduate welcome.
• Candidate with more experience will be considered as Senior Research Technician.