Technical Lead

5 days ago

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

We are seeking a highly skilled 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.
  • 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.
  • Lead/participate in project meetings as required.
  • Provide technical input and evaluation for the establishment of specifications for new products.
  • Identify and implement continuous improvements within the pharmaceutical development department.
  • Ensure all equipment is adequately maintained and to carry out qualification, cleaning, and calibration of equipment as required.
  • Ensure compliance with EHS policy, cGMP, and other business regulations and participate in risk assessments, audits, and incident investigations.
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.
  • 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.
  • Enthusiastic and hard-working individual, highly motivated to achieve technical targets with an ability to multitask.
  • Strong problem-solving and troubleshooting skills.
  • Strong communication skills with a demonstrable record of working as a team and cross-functionally.
Desirable Criteria:
  • Masters or PhD in Chemistry, pharmaceutical sciences.
  • Working knowledge of GMP and (V)ICH requirements.
  • Knowledge/experience of Mass spectrophotometry, NMR.
  • Experience of supporting ANDA regulatory submission.
  • Ability to critically review scientific literature.
  • Excellent report writing and presentation skills.
  • Working knowledge of Quality by Design principles.

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