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JOB SUMMARY The 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 DUTIES
- Development 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, robustn

📌 R&D Formulation Scientist (España)
🏢 PCI TRGR Penn Pharmaceutical Services
📍 España