Jobs, fresher vacancy - Associate Director, Formulation Science • Cambridgeshire

Company: Bicycle Therapeutics

Cambridgeshire

Job DescriptionReporting into the Director of Formulation Science, the Associate Director is a remote role and will be responsible for supporting the formulation and process development 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 phase appropriate formulation development, scale up and drug product manufacturing at Contract Development & Manufacturing Organization’s (CDMO’s) through a period of significant growth. This role requires an ambitious scientist with experience of leading the formulation science elements of integrated CMC programs that deliver high quality, cost effective and robust medicines for patients. Leading formulation development and drug product manufacturing through CDMOs and a track record of innovation are key elements of the role. A broad experience of formulation including product and process design, technology transfer, phase appropriate qualification and process validation is essential.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 design, development, phase appropriate qualification and validation of the formulated product activities for assigned projects from the BicycleTx portfolio.Identify opportunities to improve productivity and efficiency in projects within formulation science.Responsible for working as an integral part of diverse teams including CDMO formulation science and drug product manufacturing teams.Represent formulation science in project teams ensuring project alignment and fostering productive relationships with other core functions across the organization.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 patents, scientific reports and global regulatory submissions.Contribute to product stability study programs.Lead the development of scientifically sound and data driven formulations and drug products.Oversee formulation and formulation manufacturing activities at CDMOs, including the review and approval of manufacturing records, forms, methods, protocols and reports.