Associate Director, Process Chemistry

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 Process Chemistry the Associate Director can be a remote based role and will be responsible for leading process chemistry 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 process development and cGMP manufacturing through early development through to process validation at Contract Development & Manufacturing Organization’s (CDMO’s).This role requires an ambitious scientist with experience of leading process chemistry activities within integrated CMC programs that deliver high quality, cost effective and robust medicines for patients. A track record of innovation in process development and manufacturing are key elements of the role. A broad experience of drug substance process development, manufacturing, validation and registration is desirable.You will be excellent at stakeholder communication, building effective relationships and managing multiple demands and shifting priorities. You are flexible, 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 responsibilitiesResponsible for design, development and phase appropriate execution of manufacturing for assigned BicycleTx projectsOversee process chemistry activities at CDMOs, including the review and approval of MBR’s, EBR’s and campaign reports Identify opportunities to improve productivity and efficiency in drug substance manufacturing activitiesResponsible for working as an integral part of diverse teams including CDMO process chemistry teamsLead process chemistry activities within assigned project teams ensuring project alignment and fostering productive relationships with other core functions across the organizationEnsure data integrity and foster an environment of knowledge sharing throughout the medicine development lifecycle processEnsure compliance with regulatory standards including GMP, ICH, EMA and FDA guidelines.Play an active role in developing content and engagement with academic collaborators and advisorsContribute to the preparation of patents, scientific reports and global regulatory submissions.Contribute to the development of phase‐appropriate control strategies for drug substanceContribute to the development of scientifically sound and data driven specifications.QualificationsEssentialWide ranging understanding of contemporary organic chemistry and data driven process developmentWide ranging experience of working with complex organic molecules from candidate selection through to regulatory submission and subsequent commercial launchManaging technical execution of manufacture at CDMOsStrong grasp of related disciplines including discovery chemistry, analytical chemistry, formulation science, intellectual property and regulatory affairsTechnologically savvy, with a keen interest in driving value and building capabilityHighly collaborative, strong relationship building skills with a high level of integrity.First class communication and influencing skills to with the ability to manage multiple stakeholdersDesirableCharacterisation and Validation of manufacturing processesExperience in peptide manufacturingExperience in HPAPI manufacturingExperience in statistical analysis software (e.g. JMP)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.