Formulation Development Scientist
6 days ago
Ruislip
We are looking for a skilled and driven Formulation Development Scientist to join our UK manufacturing site. This role acts as the critical technical bridge between our India-based R&D centre and the UK Technology Transfer (TT) department, supporting the seamless transition of liquid products from development through to commercial manufacturing. Key Responsibilities • Lead and support pilot batch manufacturing, scale-up batches, and troubleshooting of commercial batch failures at the UK site., • Serve as the primary technical liaison between the India R&D team and the UK TT department, ensuring effective knowledge transfer and alignment on formulation strategies., • Execute and oversee technology transfer activities for oral liquid and suspension products, ensuring compliance with regulatory requirements and internal quality standards., • Develop and optimize homogenisation processes for large-volume liquid products, ensuring product uniformity, stability, and consistency at scale., • Prepare and review technical documents including batch manufacturing records, technology transfer reports, process descriptions, and deviation investigations., • Identify root causes of manufacturing issues and implement robust corrective and preventive actions (CAPAs)., • Collaborate cross-functionally with QA, QC, Regulatory Affairs, and Manufacturing teams to support product lifecycle activities., • Contribute to process validation, equipment qualification, and process analytical technology (PAT) initiatives as applicable., • Stay current with regulatory guidelines (ICH, MHRA, EMA) relevant to liquid dosage form development and manufacturing. Qualifications & Experience Education • M.Pharm / M.Sc. in Pharmaceutics, Pharmaceutical Sciences, or a closely related discipline., • Ph.D. is an advantage but not mandatory. Experience • 6-12 years of hands-on experience in pharmaceutical formulation development, with a focus on oral liquids and suspensions., • Demonstrated experience in scale-up and technology transfer of liquid dosage forms., • Practical experience with homogenisation equipment (high-shear mixers, rotor-stator homogenisers) at pilot and commercial scale., • Prior exposure to a cross-site or cross-functional TT role is highly desirable. Technical Skills • Strong understanding of formulation principles for oral liquids and suspensions (rheology, particle size, physicochemical stability)., • Familiarity with ICH Q8/Q9/Q10 guidelines and QbD principles., • Experience with GMP manufacturing environments and documentation practices., • Working knowledge of relevant regulatory frameworks (MHRA, EMA, ANDA/CTD as applicable). Soft Skills • Strong communication skills — able to operate effectively across geographies and functions., • Analytical and structured problem-solving mindset., • Self-driven with the ability to manage multiple priorities independently., • Collaborative team player with a proactive approach