JOB PURPOSE

• The Stability Hub lead is responsible for fostering a culture of collaboration, empowerment, and shared accountability within the Stability Hub.
• This role is instrumental in defining and testing the composition and physical attributes of new products and plays a critical part for the stability for all products developed and manufactured by BCH.

YOUR TASKS AND RESPONSIBILITIES

• Perform stability testing on products to assess their shelf-life and performance characteristics.  
• Lead the design and execution of stability studies, monitoring product stability and providing stability reports for regulatory submissions, ensuring compliance and adherence to industry standards.
• Establish and maintain stability testing programs to evaluate the shelf-life and performance of our products.
• Perform maintenance and calibration of laboratory instruments and equipment, ensuring proper functionality and accuracy.
• Ensure proper documentation, data integrity, and timely completion of stability studies, and associated reports, overseeing the implementation of robust documentation practices and adherence to data integrity principles.
• Monitor and ensure compliance with relevant safety guidelines and regulations within the analytical development and lab stability areas.
• Ensure compliance with regulatory requirements, industry guidelines, and Good Manufacturing Practices (GMP) in all stability testing activities, driving a culture of compliance and quality throughout the lab.
• Stay updated with regulatory changes, the latest advancements in stability techniques and technologies, and contribute to their implementation within the organization.
• Collaborate closely with cross-functional teams, including Research & Development, Quality Assurance, and Manufacturing, to drive alignment, coordination, and shared responsibility for product development, quality, and continuous improvement initiatives.
• Manage relationships with external vendors and contract research organizations, ensuring effective collaboration and timely delivery of services.
• Establish and maintain relationships with external partners, contract research organizations (CROs), and regulatory agencies, representing the Stability Hub and actively engaging in industry forums and collaborations.
• Drive innovation and the adoption of advanced technologies, analytical techniques, and best practices within the lab, leveraging external partnerships and collaborations to enhance capabilities and stay at the forefront of industry advancements.
• Guide, coach and support a team of analytical scientists and technicians, and other lab personnel, to achieve departmental goals and objectives, fostering a culture of ownership, excellence, collaboration and continuous improvement.

WHO YOU ARE

• Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, with +8 years of prior experience in analytical development, stability testing, and laboratory management within the pharmaceutical or biotechnology industry.
• Master’s degree or higher, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, with +6 years of proven experience in analytical development, stability testing, and laboratory management within the pharmaceutical or biotechnology industry.
• Ph.D. degree, in a relevant scientific field (e.g., Chemistry, Biochemistry, Biotechnology), or international equivalent, with +3 years of proven experience.
• Expert knowledge of regulatory guidelines (e.g., FDA, EMA), industry guidelines (e.g., ICH) and industry best practices pertaining to analytical development and stability testing studies.
• Expert knowledge of laboratory safety practices and procedures.
• Proficiency knowledge in analytical techniques such as HPLC, GC, dissolution testing, and spectroscopy.
• Expert knowledge in analytical instruments usage, statistical analysis software and data management systems.
• Strong knowledge of regulatory requirements and quality standards related to analytical development and stability testing is a plus.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively across global teams, to foster collaboration, open communication, and shared ownership among team members and stakeholders.
• Excellent English communication skills, both written and verbal. Other languages are a plus.
• Strong strategic thinking. Excellent problem-solving and decision-making abilities, with a focus on quality, compliance, and shared accountability.
• Strong attention to detail and project management skills, including the ability to prioritize, plan, and execute multiple projects simultaneously in a collaborative environment.