Technical Lead

7 days ago

Newry, United Kingdom Norbrook Full time
Job Title: Technical Lead

We are seeking a highly skilled and experienced Technical Lead to join our Pharmaceutical Development team at Norbrook. As a Technical Lead, you will be responsible for leading and providing technical support to the team in relation to the design, execution, and reporting of reverse engineering studies for new products.

Key Responsibilities:
  • Lead the design and execution of reverse engineering studies to support the development process for pharmaceutical equivalence projects.
  • Develop and validate analytical methods, where required, to support reverse engineering studies in accordance with relevant guidelines.
  • Lead and support the development and validation of dissolution studies within the department.
  • Provide technical support to the pharmaceutical development team to aid in troubleshooting of analytical methods.
  • Compile and review protocols and reports in line with both industry standard and company procedures.
  • Support the preparation of documentation and responses to regulatory submissions and queries.
  • Maintain an awareness of current guidelines in UK/Ireland, EU, US, and ROW in relation to industry best practice for reverse engineering studies, dissolution studies, method development, and validation.
Requirements:
  • Bachelor's Degree in a chemistry, analytical, or pharmacy-related discipline.
  • At least 5 years of relevant, post-graduate qualification experience in a pharmaceutical development role.
  • Extensive experience in the development and validation of methods for APIs and excipients in finished products using a wide range of techniques.
  • Expertise in dissolution method development and application.
  • Experience in the field of reverse engineering.
  • Excellent computer skills, including Microsoft Office suite, particularly the ability to trend data using an appropriate statistical package.
Desirable Criteria:
  • Masters or PhD in Chemistry, pharmaceutical sciences.
  • Working knowledge of GMP and (V)ICH requirements.
  • Knowledge/experience of Mass spectrophotometry, NMR.
  • Ability to critically review scientific literature.
  • Excellent report writing and presentation skills.

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