What are the responsibilities and job description for the Cell and Gene Therapy Specialist position at Novartis?
As a Senior Manager, you will be responsible for leading our Cell and Gene Therapy Analytical Operations Bioanalytics group. In this pivotal position, you will serve as a crucial link among Analytical Operations, Analytical Development, Pilot Plant manufacturing, Quality Assurance, Instrument Validation, and Technical Operations. Your expertise in quality control and management will enable you to make informed decisions, drive process improvements, and ensure compliance with regulatory requirements.
You will have the opportunity to work closely with cross-functional teams, including Quality Assurance, Instrument Validation, and Technical Operations. You will be responsible for coordinating and supervising all clinical testing and method validation activities of the assigned team. You will provide guidance and technical support to team members, ensuring efficiency and accountability within the group. Additionally, you will mentor and coach team members to foster career development and advancement.
This is a unique opportunity to join a dynamic and innovative company and contribute to the development of life-changing therapies. The ideal candidate will have a Bachelor's degree with a minimum of 6 years of quality control experience in biotech or pharmaceutical companies, including at least 2 years of direct people management experience. They must also possess knowledge of cGMP, ICH guidelines, USP/EP/JP, and 21CFR Part 11. Strong communication, writing, and presentation skills are essential for success in this position.
You will have the opportunity to work closely with cross-functional teams, including Quality Assurance, Instrument Validation, and Technical Operations. You will be responsible for coordinating and supervising all clinical testing and method validation activities of the assigned team. You will provide guidance and technical support to team members, ensuring efficiency and accountability within the group. Additionally, you will mentor and coach team members to foster career development and advancement.
This is a unique opportunity to join a dynamic and innovative company and contribute to the development of life-changing therapies. The ideal candidate will have a Bachelor's degree with a minimum of 6 years of quality control experience in biotech or pharmaceutical companies, including at least 2 years of direct people management experience. They must also possess knowledge of cGMP, ICH guidelines, USP/EP/JP, and 21CFR Part 11. Strong communication, writing, and presentation skills are essential for success in this position.
