Principal Scientist, Preformulation and Biopharmaceutics

Principal Scientist, Preformulation and Biopharmaceutics

Jazz Pharmaceuticals

Sittingbourne, United Kingdom

Brief Description

The Discovery and Medicinal Chemistry Department at Jazz Pharma is seeking an enthusiastic scientist to join the Preformulation & Biopharmaceutics at the Kent Science Park site in Sittingbourne. You will work together with other CMC scientists to advance drug candidates from lead optimization to proof of concept. This role designs and executes elaborate experiments for pharmaceutical sciences projects and demonstrates resourcefulness in running multiple activities concurrently, all related to achievement of goals/objectives.

Essential Functions/Responsibilities

  • Collaborate within CMC and cross-functional teams as the pre-Formulation lead and actively contribute to deliverables and engage in cross-functional technical review and troubleshooting;
  • Deliver and oversee the optimization of pre-clinical and clinical formulations through rational experimental design, thoughtful execution, and clear data interpretation;
  • Carry out solubility and dissolution experiment to assess the stability and predict the bio-performance of our internal formulations;
  • Identify gaps in internal formulation/biopharmaceutics capabilities and where appropriate lead an effort to implement suitable technologies;
  • Independently set up solid-form and/or drug product related specifications for CoA;
  • Manage, coach and mentor more junior members of staff. Provide clear scientific and technological leadership to direct reports;
  • Comply with all relevant safety and GxP procedures;
  • Plan and prioritise own, and team’s work with input from senior manager when required;
  • Involve in CRO’s selection process. Provide an oversight of the partnership.

Required Knowledge, Skills, and Abilities

  • Keep updated of current literature and recent advancements in Biopharmaceutics and Formulation technologies and instrumentation;
  • Knowledge of the interlink between drug substance crystallisation process, material characteristics and impact on drug product development;
  • Good knowledge of pharmacology/DMPK/Tox principles and able to support these areas from drug product perspective;
  • Able to interpret complex technical data;
  • Good knowledge of statistical design of experiments;
  • Team player, able to communicate clearly (excellent writing and presentational skills);
  • Strong knowledge and hands-on experience in drug substance/ drug product characterization is a plus;
  • Knowledge in in silico physiologically-based pharmaceutical models to predict in vivo performance of intravenous and oral formulations is a plus;
  • Knowledge of relevant FDA and EMA regulations is a plus.

Required/Preferred Education and Licenses

  • PhD/Master’s/Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Material Sciences or Chemical Engineering, with 4- 6 years relevant industrial experience.

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