Senior/Principal Formulation Scientist
South West of England
Attractive salary & package
Reporting to the Unit Manager, the Senior/Principal Formulation Scientist will:
- Be a technical resource to ensure the pharmaceutical development (formulation and process) of New Chemical Entities for inhalation from the candidate selection for the clinical phase to the full development phase.
- Will be involved in the development of novel formulation platforms and lifecycle management activities.
- Will lead formulation, technical innovation and continuous improvement ensuring that all quality and productivity targets are achieved through the optimum use of resources.
- Have effective communication skills with all team members and are required to ensure completion of the product development for their intended use in accordance with the project deliverables, and in being the primary point of contact for external CROs/CDMOs, suppliers and the project teams.
- Working with the project team and external contractors, the ability to manage a range of activities including drug substance micronisation, formulation feasibility, process development, scale-up, tech transfer, specifications setting, filling studies, packaging, device selection support; is essential.
- These activities will be carried out supporting Tox batch manufacture; Phase I and Phase II batch manufacture for stability studies and clinical trials supplies.
- Will also provide overall technical leadership and supervision of EPD formulation activities, including cGMP compliance and improvements, as well as manage CAPEX and efficiency improvements (i.e. lean).
- Life Sciences degree required.
- Significant experience and able to demonstrate knowledge in the development of pharmaceutical dosage forms in R&D departments of pharmaceutical companies; experience in the inhalation products field.
- Complete understanding and application of principles, concepts, practices, and standards for pharmaceutical formulation development.
- Experience in all aspects of external contractor management (CROs/CDMOs).
- Good knowledge and experience in formulation and process development of medicinal products, including development of inhalation products (DPI, pMDI, nebulised product).
- Experience with testing of inhalation products.
- Excellent knowledge of manufacturing process development, definition of CPP (Critical Process Parameters) and formulation robustness.
- Experience in process validation and technology transfer activities.
- Knowledge of solid-state chemistry and powder physical properties.
- Basic knowledge of inhalation devices.
- Experience in dry powder formulation development and processing, including particle size reduction and particle engineering processes.
- Experience in MDI and liquid formulation development and processing.
- Experience in a wide range of technical aspects related to formulation needs for drug substance, formulation feasibility, scale-up, tech transfer, specifications setting, filling studies, packaging, device selection support.
- Experience in GMP documentation technical writing and review such as: protocols, reports, batch manufacturing record, robustness studies, IND/IMPD.
- Excellent written and verbal communication, interpersonal and leadership skills.
- Working knowledge of Six Sigma and/or Lean tools.
- Ability to coach, mentor and teach.
- Excellent decision making, prioritisation, time management, problem solving and analytical skills.
- Detail-oriented with the ability to work globally and under tight deadlines.
- Proven to be innovative and creative with an appreciation of new technologies and the reasons that drive innovative thinking.
- 50% normal office and meeting room conditions.
- 50% laboratory and manufacturing environment including exposure to active raw materials and finished products.
- Must be able to wear the required Personal Protective Equipment (PPE) as deemed necessary by current company and site Health and Safety procedures.
- Some off shift and weekend work will be expected if required; there are requirements for occasional travel within the UK and abroad to support projects.
If you have the skills/experience required and are interested in the role please apply online, if you have any questions please call on 0121 728 8455.
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