Qilu Pharmaceutical Co., Ltd. is one of the largest Chinese pharmaceutical enterprises focused on developing, manufacturing and marketing of drugs and therapeutic APIs. To build up a world-class Chinese Pharmaceutical enterprise, Qilu is looking for exceptional individuals (director level) who share our passion for the treatment of diseases with significant impacts on human health.
Position 1: Head of cGMP Monoclonal Antibody Manufacture at Qilu Pharmaceutical Co., Ltd.
at Jinan, Shandong Province, China
Job Summary
Contribute technical leadership, management and oversight for the development and scale up of robust mammalian cell culture/purification processes based upon quality by design (QBD) concepts that address critical quality attributes and process parameters. Ensure the responsible cGMP manufacturing operations in the highest quality standards with cost effective manner. Establish and maintain an understanding of current trends and emerging processes in both upstream and downstream technologies to ensure that the team is at forefront of biologics development.
Responsibilities:
· Responsible for daily manufacture operation and management of monoclonal antibody products, including but not limited to, manufacture work quality assurance, task completion assurance, workers management, assets management as well as safety assurance;
· Responsible for process optimization and refinement geared towards manufacturing compatibility and capacity by emphasizing on the existing processes robustness improvement and closely cooperating with R&D department for new products process efficiently transferred to trail/commercial manufacturing process;
· Responsible for organizing and establishing cGMP compliance monoclonal antibody oriented biologics product manufacturing systems, and other quality and cost effectiveness related managing systems in order to maintain overall company’s biologics manufacture running in the highest cost effective manner without compromises of the highest product quality standards;
· Ensure well-organized, clear and complete records of all manufacturing activities across areas of the responsibilities.
· Develop and maintain SOPs, policies and guidance documents relevant to the areas of the responsibilities.
· Apply innovative technical ability and knowledge to critically analyze experimental data and results.
Qualifications:
· Ph.D. or MS degree in chemistry, biochemistry, (bio) chemical engineering (or other relevant physical or life sciences discipline) or MS with equivalent education or experience is required.
· Over 5 years of experience in biologics drug development and cGMP manufacture in biotech or Pharma. with significant experience in the areas of protein/monoclonal antibody expressions, purification and characterization and the experiences guiding/mentoring team in a fast pace environment;
· Experience with Design of Experiments (DOE) approach for process development and characterization
· Excellent management, communication, coordination and overall planning skills.
Position 2: Head of QA of Monoclonal Antibody Biologics Manufacture in Qilu Pharmaceutical Co., Ltd. Jinan, Shandong Province, China
Position Summary
This position will provide technical, operational and strategic leadership and expertise in the development and implementation of GMP quality systems to ensure that all antibody based biologics products in company are in compliance with Chinese and international regulations, laws, and guidelines (e.g. US FDA, EU Directives, ICH, and National regulations) governing the manufacturing and testing of both investigational clinical trial materials and commercial drug products.
Responsibilities:
· •Interfaces and oversee Qilu’s monoclonal antibody biologics manufacture operations in compliance with cGMP standards and maintain the continuous efforts in improving biologics product qualities.
· Perform real-time batch record reviews as assigned
· Support quality systems QI(deviation), CAPA, Change Control, Environmental Monitoring, etc. to support lot release and continuous improvement
· Performs walkthroughs and audits as required
· Review and approve of, SOPs, Process Descriptions and validation protocols and reports as assigned
Qualifications:
· Ph.D. or MS degree, preferably in Biology or Chemistry
· Minimum 5+ years Quality Assurance GMP experience in the pharmaceutical/ biotechnology industry (commercial experience preferred);
· A thorough understanding of FDA, EMA and ICH quality regulations in regards to monoclonal antibody based biologics products’ manufacture process;
Position 3: Head of QA of Monoclonal Antibody Biologics Manufacture in Qilu Pharmaceutical Co., Ltd. Jinan, Shandong Province, China
Position Summary
As a QC head of monoclonal antibody product cGMP manufacture, this incumbent will provide technical, operational and strategic leadership and expertise in the development and implementation of GMP quality systems to ensure that Qilu’s monoclonal antibody products manufacture is in compliance with US and international regulations, laws, and guidelines
Responsibilities:
· Working closely with Analytical Development, build a sustainable cGMP Quality Control platform to support Qilu’s growing portfolio of therapeutic monoclonal antibody product manufactures.
· Oversee and provide crucial cGMP QC overviews on QC vendor management, cGMP sample handling & testing, QC stability program, QC release, stability data analysis, trending out of specification investigations, issuing Certificates of Analysis, and the support on quality agreements writing and internal and external audits.
Qualifications:
· BS/MS in a scientific field of study with 5+ years of relevant experience working in Quality Control in the Pharmaceutical/ biotech industry for manufacturing biologics products at cGMP environment;
· In-depth technical and regulatory understanding of cGMP biologics manufacture and QC, as well as applicable international regulations and standards in all phases of clinical development and commercial manufacture.
· Proven leadership experience and people management skills with the desire and ability to work in a fast-paced manufacturing environment
· A conscientious, rigorous and down-to-detail worker, a strong analyzer and problem solver
Contact Information:
Applicants should send your updated CV and cover letter to John Zhang, Ph.D. via for consideration.