Full-Time Associate Director, Formulation Science

Role purposeReporting into the Director of Formulation Science the Associate Director, Formulation Science is a remote role (based in the UK) and will be responsible for supporting the formulation science activities to take BicycleTx projects from candidate selection through to registration and product launch.

Key Responsibilities:

• Responsible for design, development, phase appropriate qualification and validation of the formulated product activities for assigned projects from the BicycleTx portfolio, including radiopharmaceutical products.
• 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, isotope chelation, manufacturing and radiopharmaceutical pack assembly 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 for formulations and radiopharmaceuticals 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, formulation manufacturing, isotope chelation development, radiopharmaceutical manufacturing and pack assembly activities at CDMOs, including the review and approval of manufacturing records, forms, methods, protocols and reports.

Essential skills:

• Exceptionally strong and wide-ranging understanding of contemporary formulation science, including radiopharmaceuticals.
• Wide ranging experience of working with complex organic molecules from early formulation and formulation process development through to regulatory submission and subsequent commercial launch.
• Proven experience in the development and manufacture of lyophilized parenteral products.
• Experience of working with synthetic peptides / PEGylated materials to include formulation strategies for improving API dissolution and product stability.
• Experience of working with highly potent API would be an advantage.
• Sterile drug product manufacturing experience, including master and executed batch record review and sign off, QBD including quality-based manufacturing risk assessments and process validation.
• Strong grasp of related disciplines including discovery chemistry, process chemistry, analytical science, intellectual property and regulatory.

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