Senior Formulation Scientist

Senior Formulation Scientist

Pharmaceuticals

Location Chippenham

Salary Up to £50,000

Contract Permanent

Reference HMSNRFormSc

Date Posted

Consultant

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A rapidly growing pharmaceutical company is looking for a highly experienced Senior Formulation Scientist to join their Respiratory R&D facilities in Wiltshire. The role will involve working on New Chemical Entities and Novel Formulations for Phase I Clinical Studies, Late Phase Projects and Lifecycle Management.

Role Responsibilities:

  • Lead project-specific respiratory formulation development
  • Support the Unit Manager as a technical resource for projects involving Early Product Development, external Contract Management, and analytical, formulation and process activities coordination
  • Design appropriate formulation and stability studies including the use of QbD where appropriate
  • Ensure Quality and Productivity targets are achieved through continuous improvement and efficient use of resources
  • Be primary point of contact for external CROs/CDMOs, suppliers and global CMC Project Teams
  • Lead and manage the project team in drug substance micronisation, formulation feasibility, scale-up, tech transfer, specifications setting, filling studies, packaging, and device selection support
  • Provide technical leadership regarding cGMP compliance and improvements
  • Design and execute experimental protocols in a timely manner and in compliance with company requirements including the interpretation and reporting of results and findings
  • Organisation and scheduling of work and resources to timescale and budget
  • Conduct necessary safety assessments and qualification plans according to current procedure, authoring, reviewing and managing the execution of IQ/OQ/PQ protocols
  • Writing, Reviewing and Approval of SOPs and Risk Assessments

Ideal Skills & Qualifications:

  • PhD in Life Sciences
  • Significant proven experience in respiratory/inhalation formulation, as well as range of other dosage types
  • Experience with testing of inhalation products
  • Working knowledge of powder mixing (DPI), pMDI nebulized formulations, particle engineering, solid-state characterisation, formulation feasibility, scale-up & tech transfer
  • Experience in managing external CROs, CDMOs and suppliers; Tox Batch Manufacture; Phase I and II Stability Studies as well as Clinical Trials Supply
  • Knowledge of inhalation devices, experience in selection and handling
  • Flexible and adaptable with an open-minded view and creative problem-solving skills
  • Knowledge of GMP and pharmaceutical regulations
  • Excellent communication skills across all departments

If you are interested or have any questions about this role, feel free to contact Harriet (07851 246 846) at CY Partners.

Due to the current Covid-19 crisis, many sites will be limiting visitors, including for interviews. The next steps in this process will be a video call interview, with an on-site visit to follow when restrictions are lifted.

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Senior Formulation Scientist

Pharmaceuticals

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