Senior Team Manager, Analytical Chemistry
hace 1 día
Witney
Reporting to the Testing and Analytical Manager, you will lead the Analytical Chemistry laboratory responsible for supporting the release, stability testing, and lifecycle management of innovative combination products that integrate both pharmaceutical and medical device components. The laboratory will play a critical role in ensuring the quality, compliance, and timely release of products used by millions of people worldwide Initially leading a growing team, you will have responsibility for building, developing, and scaling the organisation as product volumes increase. This role offers a unique combination of scientific leadership, operational management, and strategic influence. You will be the site's analytical chemistry authority, providing technical direction while ensuring robust laboratory operations, regulatory compliance, and continuous improvement., • Ensure timely execution of product release, stability, and investigative testing, • Plan and prioritise workloads to meet business and regulatory commitments, • Maintain compliance with GMP, ISO 13485, and global regulatory requirements, • Lead complex investigations, including OOS, OOT, and deviation management, • Serve as the analytical chemistry subject matter expert for HPLC assay and impurity testing, Dissolution testing, Total drug content analysis, Method troubleshooting and problem solving, • Support method development, transfer, validation, and lifecycle management activities, • Provide technical guidance to Quality, Manufacturing, Regulatory Affairs, and R&D teams, • Develop long-term laboratory capability and technology strategies, • Lead laboratory modernisation and continuous improvement initiatives, • Support new product introduction and combination product programmes, • Represent the site during audits, inspections, and divisional technical forums, • Degree in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific discipline, • Significant experience leading teams within a GMP-regulated analytical laboratory, • Strong technical expertise in analytical chemistry techniques, including HPLC and dissolution testing, • Experience supporting analytical method validation, transfer and life cycle management, • Strong understanding of GMP, data integrity, and regulated laboratory environments, • Proven ability to lead, coach, and develop technical teams, • Excellent problem-solving, communication and stakeholder management skills, • Experience supporting pharmaceutical, medical device, or combination product testing programmes, • Understanding of regulatory requirements applicable to drug-device combination products, • Knowledge of ICH analytical validation requirementsExperience supporting regulatory inspections and audits, • MSc or PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline, • Experience supporting new product introductions and technology transfer activitiesundefined, • You may already have experience working with combination products or drug-device systems and understand the unique analytical, quality, and regulatory challenges these products present. However, we also welcome applications from experienced analytical chemistry leaders from pharmaceutical, medical device, biotechnology, or related regulated industries who are eager to develop expertise in this exciting and growing area Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries., This role offers the opportunity to lead a critical function supporting the release of innovative products that improve lives globally. You will have the chance to build and shape a high-performing analytical team, influence technical strategy, and contribute to the future of combination product development at Abbott. • Competitive compensation and benefits package, • Structured development and career growth opportunities, • A collaborative, innovative environment with real impact on patient outcomes #J-18808-Ljbffr