Full-Time Associate Director, Analytical Science

Reporting into the Senior Director of Analytical Science, the Associate Director can be a remote based role ( ideally 1 day onsite per month, open to 1 day per quarter), and will be responsible for leading the analytical science activities to take BicycleTx projects from candidate selection through to registration and product launch.

Key responsibilities:

1. Responsible for the design, development, phase appropriate qualification and verification/validation of the analytical methodologies of BicycleTx projects.
2. Identify opportunities to improve productivity and efficiency in projects and analytical science.
3. Responsible for working as an integral part of diverse teams including CDMO analytical science teams.
4. Lead the analytical science in project teams ensuring project alignment and fostering productive relationships with other core functions across the organisation.
5. Ensure data integrity and foster an environment of knowledge sharing throughout the medicine development lifecycle process.
6. Ensure compliance with regulatory standards including GMP, ICH, EMA and FDA guidelines.
7. Play an active role in developing content and engagement with academic collaborators and advisors.
8. Support the preparation of global regulatory submissions, scientific reports and patents.
9. Develop phase‐appropriate quality control strategies for drug substance and drug product.
10. Manage the drug substance and drug product stability study programs.
11. Lead development of scientifically sound and data driven specifications.
12. Oversee analytical and QC activities at CDMOs and Contracting Testing Laboratories, including the review and approval of test records, forms, methods, protocols and reports.
13. 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.
14. Ensure documentation is maintained within the quality management system.

Essential skills:

• Extensive understanding of contemporary analytical science
• Wide ranging experience of working with complex organic molecules from candidate selection through to regulatory submission and subsequent commercial launch
• Previous experience of working with peptide drug substances
• Experience of working in a GMP environment, requiring the review and upkeep of GMP documentation
• Previous experience of radiopharmaceuticals
• Strong grasp of related disciplines including discovery chemistry, process chemistry, formulation science, intellectual property and regulatory
• Highly collaborative, strong relationship building skills with a high level of integrity
• First class communication and influencing skills to with the ability to manage multiple stakeholders

Company benefits:

• State-of-the-art campus environment
• Flexible working environment
• Competitive reward including annual company bonus
• Employee recognition schemes
• 28 days annual leave + option to buy up to 5 additional days annually
• Employer contribution to pension
• Life assurance cover
• Private Medical Insurance, including optical and dental cover
• Group income protection
• Employee assistance program
• Health Cash Plan
• Company subsidized gym membership
• Option grant to subscribe to shares in Bicycle Therapeutics plc
• Cycle to work scheme
• Building a diverse workforce

What is the last date for applying to the job?

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