We are partnering with an established and growing biotechnology consultancy that supports innovative organisations across the life sciences sector. As they continue to grow, they are looking to appoint a Chemical Development Consultant on an ad hoc basis to support projects as they come in. This position is fully remote and outside of IR35 for UK candidates.
The Chemical Development Consultant will provide expert scientific and technical support across the development lifecycle for small-molecule active pharmaceutical ingredients (APIs). The role involves senior-level advisory input, oversight of process development and scale-up, and direct contribution to technology transfer, clinical supply and commercial manufacturing readiness.
Key Responsibilities:
Provide expert chemical development advice and strategic input across small-molecule programmes, translating laboratory syntheses into robust, scalable API manufacturing processes suitable for clinical supply and commercial manufacture.
Evaluate and develop synthetic routes, selecting appropriate starting materials, reactions, reagents and solvents, and assessing technical feasibility, supply chain risks and suitability for manufacture.
Optimise reaction conditions and process operations to improve yield, purity, reproducibility, cost and environmental performance, using structured experimentation and process understanding to support development decisions, including Quality by Design approaches and use of Design of Experiment (DoE).
Develop impurity control strategies, identifying sources and fate of process impurities, residual solvents and potentially mutagenic impurities, and working with analytical and toxicology specialists to establish appropriate controls.
Develop and review purification, isolation, crystallisation and drying processes to achieve required API purity, solid form and physical properties in collaboration with solid-state and formulation specialists.
Plan and oversee scale-up from laboratory to pilot and commercial manufacture, assessing reaction safety, equipment suitability and process performance, and troubleshooting technical issues during manufacturing campaigns.
Support CDMO selection and technical oversight, reviewing development proposals, experimental data, manufacturing capabilities and project deliverables to ensure alignment with client requirements, timelines and supply needs.
Support technology transfer to manufacturing teams and CDMOs, preparing and reviewing process descriptions, development reports, batch instructions and transfer documentation to enable reliable process reproduction.
Contribute to API sections of regulatory submissions and responses to agency questions, providing technical justification for starting material selection, manufacturing processes, impurity controls and proposed control strategies.
Collaborate closely with analytical development, formulation, quality assurance and regulatory teams to align chemical development activities with GMP requirements, relevant ICH guidance and overall project objectives.
Requirements:
Degree or equivalent in organic chemistry, process chemistry or a related discipline.
Demonstrated experience delivering small-molecule API process development within pharmaceutical or CDMO environments.
Strong working knowledge of synthetic chemistry, impurity control, purification, crystallisation and process scale-up.
Experience in technology transfer, GMP manufacturing support and contribution to regulatory submissions.
Comfortable operating in senior advisory or consultancy roles, with the ability to communicate complex chemical development concepts clearly to multidisciplinary teams.