Reporting into the Director of Analytical Science the Associate Director can be a remote based role, and will be responsible for leading the analytical science activities to take BicycleTx projects from candidate selection through to registration and product launch. A key aspect of the role will be leadership and technical expertise in analytical method development, verification and validation for release and stability testing of drug substance, raw materials, intermediates and drug product at Contract Development & Manufacturing Organisation’s (CDMO’s) through a period of significant growth. 

This role requires an ambitious scientist with experience of leading the analytical science elements of  integrated CMC programs that deliver high quality, cost effective and robust medicines for patients. Leading analytical development projects through CDMOs and a track record of innovation are key elements of the role. A broad experience of analytical science in both drug substance and drug product development, validation and registration is desirable.

You will be excellent at stakeholder communication, building effective relationships and managing multiple demands and shifting priorities.   You are organized, and excel at developing plans, managing progress, and delivering results.  This position will collaborate with other members of CMC, Quality Assurance, Regulatory Affairs, Commercial, and Finance teams to enable product development.

Key responsibilities:

• Responsible for the design, development, phase appropriate qualification and verification/validation of the analytical methodologies of BicycleTx projects.
• Identify opportunities to improve productivity and efficiency in projects and analytical science.
• Responsible for working as an integral part of diverse teams including CDMO analytical science teams.
• Lead the analytical science in project teams ensuring project alignment and fostering productive relationships with other core functions across the organisation.
• Ensure data integrity and foster an environment of knowledge sharing throughout the medicine development lifecycle process.
• Ensure compliance with regulatory standards including GMP, ICH, EMA and FDA guidelines.
• Play an active role in developing content and engagement with academic collaborators and advisors
• Support the preparation of global regulatory submissions, scientific reports and patents.
• Develop phase‐appropriate quality control strategies for drug substance and drug product.
• Manage the drug substance and drug product stability study programs.
• Lead development of scientifically sound and data driven specifications.  
• Oversee analytical and QC activities at CDMOs and Contracting Testing Laboratories, including the review and approval of test records, forms, methods, protocols and reports.
• Identification and development of suitable analytical methods to allow comprehensive characterisation of both the quantitative and qualitative attributes of drug substance and drug product, associated impurities and excipients.
• Ensure documentation is maintained within the quality management system
• Experience of various cultures, as Bicycle’s CDMO’s are global, with potential for global travel.