1. Implement and maintain a high standard quality assurance procedure according to current ICH guidance including China, EU and US GMP regulations. Ensure the compliance of GCP, GMP and other GxP regulatory been always met during the clinical trial, commercial manufacturing and post marketing;
2. Monitor all production and QC test process, perform necessary on-site inspections and batch records reviews to make sure all the manufacturing and QC tests meet the predefined process specification and compliance requirements for data integrity prior to the final release of the product;
3. Lead and monitor the deviation investigations, CAPAs, risk management, self- inspections, change controls, and other quality activities. Prepare and lead all regulatory audit/inspection. Be ready to address all quality related issues and take the responsibility of corrective actions and continuous improvement of the performance of quality system within the company;
4. Review and approve the quality system procedures and documentations which covering the life cycle of drug product, from clinical trials, commercial production and post-marketing monitoring;
5. Prepare the regulatory audits and inspections according to product submission progress and other triggers, responsible for corrective actions and continuous improvement of QA procedures;
6. Conduct and lead the investigations, CAPAs, deviations and Quality Risk Management and other activities during the GxP operations. Responsible for the other quality related tasks assigned to Quality Head by management team as per urgent needs or company strategy;
7. Ensure the implementation of effective business processes, procedures and practices in alignment with regulatory expectations and company policies for data integrity through its lifecycle, including GxP computer systems, hybrid systems and manual/paper systems;
8. The Job Title will be assigned by company management according to candidates experience and capability.
1. Graduate Degree (or above) in Pharmaceutical related majors including pharmaceutical sciences, medicines, biochemistry, biological sciences, etc;
2. Minimum 12 years’ working experience in Pharmaceutical industry, 8 years’ experience in Quality assurance of GMP or GxP environment. Experience of sterile manufacturing quality management is a plus;
3. Familiar with quality assurance procedures according to Chinese cGMP, EU/US GMP, GxP, GCP, ChP, EP and USP, and other applicable international guideline such as ISPE, PDA, ICH, etc;
4. Good oral and written English required, must be able to read English protocols/reports, articles, etc;
5. Overseas working experience is a plus.
1.Lead and grow a team of scientists and engineers for process development with focusing in upstream processes for antibody therapeutics using sound scientific and engineering principles to design robust and scalable upstream processes, in consideration of various bioreactor configurations and process formats.
2.Lead tech transfer to GMP manufacturing including risk assessment and mitigation strategy development. Lead and take part in cross-functional collaborations to meet project timelines and DS supply requirements.
3.Ensure all experiments and activities are documented appropriately; lead in preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA)
4.Design, manage and support process characterization studies and develop control strategies for process validation. Provide direction, support, and corrective action as needed.
5.Present scientific and technical findings in conferences or publish in journals.
1.Ph.D. in chemical engineering, bioengineering, or relevant disciplines, with more than 10 years of industrial experiences in antibody drug upstream process development and biomanufacturing.
2.With a proven track record of accomplishments in the design, development, and implementation of bioreactor cell culture processes including trouble-shooting and decision making.
3.with hands-on experience with upstream development laboratory activities. Knowledge of upstream process equipment at development and pilot scales; proven technology transfer and scale-up experience.
4.Demonstrated ability to simultaneously manage multiple projects, and to function in a collaborative/team oriented environment.
5.Demonstrated ability in leading the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA); Good verbal and written communication skills.
6.Experience in working effectively in multicultural environments is a plus. The company is headquartered in Guangzhou, China, and the position is full-time. Bio-Thera provides competitive compensation package including company stock.