R&D Formulation Scientist

hace 2 días


León, España PCI Pharma Services A tiempo completo

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI.Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.JOB SUMMARYThe Formulation Scientist under the direction of Process Development Director is responsible for the development and optimization of product formulations and the implementation of manufacturing processes. They perform this function in accordance with the GMP and FDA standards applicable to the target market and the quality criteria established by the company.JOB DUTIESDevelopment of product formulations in solution, suspension, emulsion and lyophilized forms for small molecules and biological products (mAb: monoclonal antibodies; ADC: antibody drug conjugate; proteins, peptides, oligonucleotides and high potency products).Define and update the QTPPs and CQAs of the formulation: efficacy, safety, stability, purity and potency, etc.In partnership with the client aid in the selection of suitable form of API for final drug product through pre‑formulation and formulation techniques e.g. polymorph, isomeric conformation, melting point, hygroscopicity, pH and logP, particle size.Evaluation and selection of excipients according to QTTP. Selection and concentration of the formulation excipients and definition of the CMA of the selected excipients.Design of tests to evaluate the behavior of excipients and APIs: characterization studies, compatibility, solubility, dissolution, physico‑chemical stability, etc.Application of DoE methodology to design, perform and analyze laboratory scale experiments for the optimization of formulations and their manufacturing processes.Selection, design and execution of supporting studies and documentation for the development of the project: general studies such as characterization, compatibility, robustness, stability, etc. and specific biological products studies such as freeze‑thaw, shear stress, protein content, silicone compatibility, etc.Selection of appropriate equipment, manufacturers and technologies for technical and manufacturing



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