• Cork

R.T. Lane Recruitment

Initial 12 month contract.

Report to: Scientist, Late Development and Stability Sciences dept.

Analytical Development, Cork is a department of BioTherapeutics Development. The department is responsible for Clinical Stability Management and Clinical Release/Stability testing of drug substance and drug product and is responsible for the large molecule scope of the R&D product portfolio.

Position Summary:

Reporting to Scientist, the person represents AD Cork in the Global Analytical Forums and will participate and lead on various projects, analytical techniques and testing issues in support of clinical release and stability testing.

Main duties and responsibilities:

  • Apply analytical knowledge to interpretation of generated stability and release data and ensure high quality of the delivered results working with senior colleagues in AD.
  • Overall release and stability management of product(s) according to portfolio: Evaluate chemical and physical trends. Assist in drawing conclusions on shelf-life, retest period and storage instructions under the guidance of the Scientific Integrator.
  • Participate in projects as single point of contact building product stability expertise.
  • Takes Lead on critical Lab Continuous Improvement projects and/or serve as representative on cross functional/Process teams.
  • Write SOP’s, protocols, reports and IMPD/IND regulatory filing documents.
  • Proactively identifies and drives process improvements.
  • Acts as subject matter expert on assigned analytical techniques.
  • Keeps abreast of analytical technology and compliance trends.
  • Execute assigned NME transfer programs and related projects.

Key Skills and Competencies required:

  • Strong competency in stability sciences and knowledge of regulatory stability guidelines (ICH/WHO) Innovative solutions/technical skills to troubleshoot laboratory issues.
  • Ability to work well within team structures and provide leadership.
  • Solid knowledge of physical, chemical and biological techniques is required.
  • Excellent communication skills
  • Good scientific and technical writing skills

Education and Experience:

  • A minimum of a Bachelor’s level 8 degree in Biology, Pharmacy or related scientific field is required
  • At least 3 years’ experience or related post graduate academic experience is required.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
  • Practical analytical laboratory experience in a GMP environment is required.

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