Position: Director of Analytical Development and Quality Control A clinical-stage biotechnology company pioneering the development of oligonucleotide drugs with a patient-focused and research & development-led approach is currently seeking a Director of Analytical Development and Quality Control in the Suzhou City, Jiangsu Province, China. The company has a rich and diversified pipeline of programs across infectious diseases, immuno-oncology, cardiovascular diseases, rare diseases, and inflammatory diseases. With recent strong growth, they are looking to add more key contributors to collaborate with the team. The individual will lead the team of Analytical Development and Quality Control, provide support for process development and formulation development, and closely collaborate with other CMC team members. The individual should be proactive in identifying potential issues, develop effective solutions to technical challenges, and lead team members in the execution of analytical development. Responsibilities: • Lead and manage the analytical teams. • Provide technical leadership in execution of analytical development, process development/engineering, drug substance and drug product manufacturing support, raw materials testing, as well as facility support testing. • Serve as the primary Analytical Development technical expert of the company, internally, within collaboration and with CMO’s and to regulatory agencies to ensure the company is appropriately represented in technical and compliance matters • As a key CMC member, author and review IND/NDA submission documents and support regulatory responses • Ensure adherence to GMPs, GLPs, GCPs and GDPs • Build, coach, mentor and assure appropriate management development for key personnel in his/her department
Requirements: • Ph. D. in analytical chemistry or related pharmaceutical science field and 10+ years of related experience. • Extensive knowledge of Analytical Development and Quality Control for active pharmaceutical ingredients and drug products under cGMP • Successful experience in working in a multi-disciplinary team environment.
This is a unique opportunity to grow your career with a company dedicated to its employees and its patients. If you are interested in the Director of Analytical Development role, please contact 984-464-2946 for further information.
Position: Director of Analytical Development and Quality Control
A clinical-stage biotechnology company pioneering the development of
oligonucleotide drugs with a patient-focused and research & development-led approach is currently seeking a Director of Analytical Development and
Quality Control in the Suzhou City, Jiangsu Province, China. The company has a rich and diversified pipeline of programs across infectious diseases,
immuno-oncology, cardiovascular diseases, rare diseases, and inflammatory
diseases. With recent strong growth, they are looking to add more key
contributors to collaborate with the team. The individual will lead the team of Analytical Development and Quality Control, provide support for process development and formulation development, and closely collaborate with other CMC team members. The individual should be proactive in identifying
potential issues, develop effective solutions to technical challenges, and
lead team members in the execution of analytical development.
Responsibilities:
• Lead and manage the analytical teams.
• Provide technical leadership in execution of analytical
development, process development/engineering, drug substance and drug
product manufacturing support, raw materials testing, as well as facility
support testing.
• Serve as the primary Analytical Development technical expert of
the company, internally, within collaboration and with CMO’s and to
regulatory agencies to ensure the company is appropriately represented in
technical and compliance matters
• As a key CMC member, author and review IND/NDA submission
documents and support regulatory responses
• Ensure adherence to GMPs, GLPs, GCPs and GDPs
• Build, coach, mentor and assure appropriate management
development for key personnel in his/her department
Requirements:
• Ph. D. in analytical chemistry or related pharmaceutical science field and 10+ years of related experience.
• Extensive knowledge of Analytical Development and Quality Control for active pharmaceutical ingredients and drug products under cGMP
• Successful experience in working in a multi-disciplinary team
environment.
This is a unique opportunity to grow your career with a company dedicated to its employees and its patients. If you are interested in the Director of
Analytical Development role, please contact 984-464-2946 for further
information.