Associate Director, Process Chemistry
1 week ago
Reporting 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 responsibilities
- Responsible for design, development and phase appropriate execution of manufacturing for assigned BicycleTx projects
- Oversee 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 activities
- Responsible for working as an integral part of diverse teams including CDMO process chemistry teams
- Lead process chemistry activities within assigned 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
- Contribute to the preparation of patents, scientific reports and global regulatory submissions.
- Contribute to the development of phase‐appropriate control strategies for drug substance
- Contribute to the development of scientifically sound and data driven specifications.
Qualifications
Essential
- Wide ranging understanding of contemporary organic chemistry and data driven process development
- Wide ranging experience of working with complex organic molecules from candidate selection through to regulatory submission and subsequent commercial launch
- Managing technical execution of manufacture at CDMOs
- Strong grasp of related disciplines including discovery chemistry, analytical chemistry, formulation science, intellectual property and regulatory affairs
- Technologically savvy, with a keen interest in driving value and building capability
- 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
Desirable
- Characterisation and Validation of manufacturing processes
- Experience in peptide manufacturing
- Experience in HPAPI manufacturing
- Experience in statistical analysis software (e.g. JMP)
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.
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