Pharmaceutical Development Consultant

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 Pharmaceutical 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 Pharmaceutical Development Consultant will provide expert scientific and technical support across the development lifecycle for small-molecule drug products. The role involves senior-level advisory input, oversight of formulation and manufacturing process development, and direct contribution to technology transfer, clinical supply and commercial manufacturing readiness.

Key Responsibilities:

• Provide expert pharmaceutical development advice and strategic input across small-molecule programmes, translating initial formulations into stable, reproducible drug products suitable for clinical supply and commercial manufacture.
• Develop and optimise formulations, selecting appropriate excipients and their proportions based on API properties, compatibility, intended route of administration and required product performance.
• Develop dosage forms within the relevant area of expertise, including tablets, capsules, powders, syrups, other oral liquids or aerosols, considering patient and dose requirements as well as delivery characteristics.
• Develop and optimise manufacturing processes such as mixing, compounding, granulation, drying, compression, coating and filling, identifying critical process parameters and appropriate controls to ensure consistent product quality.
• Assess product performance and stability in collaboration with analytical teams, evaluating dissolution, drug release, dose uniformity and physical and chemical stability to support formulation selection and shelf-life proposals.
• Plan and oversee scale-up from laboratory formulations to clinical and commercial production, assessing equipment suitability, process robustness and manufacturing performance, and troubleshooting issues during development and supply campaigns.
• Support CDMO selection and technical oversight, reviewing formulation proposals, development data, manufacturing capabilities and project deliverables to ensure alignment with client requirements, timelines and clinical supply needs.
• Lead or support product and process transfer to manufacturing teams and CDMOs, preparing and reviewing formulation specifications, process descriptions, development reports, batch instructions and transfer documentation.
• Contribute to drug product sections of regulatory submissions and responses to agency questions, providing technical justification for formulation composition, manufacturing processes, packaging selection and proposed product control strategies.
• Collaborate closely with chemical development, analytical development, quality assurance and regulatory teams to align product development activities with GMP requirements, relevant ICH guidance and overall project objectives.

Requirements:

• Degree or equivalent in pharmaceutics, pharmaceutical sciences, chemistry or a related discipline.
• Demonstrated experience delivering small-molecule formulation and drug product process development within pharmaceutical or CDMO environments.
• Strong working knowledge of relevant dosage forms, excipient selection, product performance, stability and manufacturing process scale-up.
• Proven experience in technology transfer, GMP manufacturing support and contribution to drug product regulatory submissions.
• Comfortable operating in senior advisory or consultancy roles, with the ability to communicate complex pharmaceutical development concepts clearly to multidisciplinary teams.