Associate Director, Formulation Science

Company Description

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.

Culture is key and all Bicycle employees actively embrace and role model our company values:

• We are Adventurous. We believe it's the way to deliver extraordinary results for our patients.
• We are Dedicated to our Mission. You can't change the world if you don't have determination.
• We are One Team. We only succeed when we work together.

Job Description

Reporting 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.

Qualifications

Essential:

• Exceptionally strong and wide-ranging understanding of contemporary formulation science.
• 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, including experience in registration batch manufacture and PPQ batch manufacturing.
• 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.
• Technologically savvy, with a keen interest in evidence in driving value and building capability through automation and innovation.
• Highly collaborative communicator with strong relationship building skills and a high level of integrity.
• First class communication and influencing skills to with the ability to manage multiple stakeholders.
• Resilient and able to work effectively in a demanding and fast-paced environment.

Additional Information

• State-of-the-art campus environment with on campus restaurant and Montessori nursery.
• Flexible working environment.
• Competitive reward including annual company bonus.
• Employee recognition schemes.
• 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually.
• Employer contribution to pension (employee does not have to contribute).
• Life assurance cover 4x basic salary.
• Private Medical Insurance, including optical and dental cover.
• Group income protection.
• Employee assistance program.
• Health Cash Plan.
• Access to company subsidized gym membership.
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
• Cycle to work scheme.

Bicycle 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.