Associate Director, Analytical Science

Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.Cultureis key and all Bicycle employees actively embrace and role model our company values: We areAdventurous. We believe it's the way to deliver extraordinary results for our patients.We areDedicated to our Mission. You can't change the world if you don't have determinationWe areOne Team. We only succeed when we work together.Job DescriptionReporting 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 advisorsSupport 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 systemExperience of various cultures, as Bicycle’s CDMO’s are global, with potential for global travel.QualificationsWide ranging 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 would be an advantage.Experience of working in a GMP environment, requiring the review and upkeep of GMP documentation.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.Additional InformationState-of-the-art campus environmentwith on campus restaurant and Montessori nurseryFlexible working environmentCompetitive reward including annual company bonusEmployee recognition schemes28 days annual leave in addition to bank holidays+ option to buy up to 5 additional days annuallyEmployer contribution to pension (employee does not have to contribute)Life assurance cover 4x basic salaryPrivate Medical Insurance, including optical and dental cover.Group income protectionEmployee assistance programHealth Cash PlanAccess to company subsidized gym membership.Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.Cycle to work schemeBicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.