Analytical Research Leader

3 days ago

Hyderabad Secunderabad Telangana, India beBeeScientific Full time

**Senior Analytical Expert**

Your responsibilities will include:

  • Design, plan and interpret complex scientific experiments for projects at different clinical phases of drug substance and drug product development with minimal guidance. You will be well-versed in regulatory guidelines, scientific literature, technology transfer and interpretation of results to draw conclusions in reports.
  • Provide scientific guidance to laboratory associates.
  • Write, review and/or approve analytical documentation, such as releases, analytical batch records, method validations, stability, technical reports and SOPs, ensuring compliance with health authorities guidelines.
  • Help define the overall analytical control strategy.
  • Contribute to scientific exchange groups within your organization.
  • Report and present scientific/technical results internally and contribute to publications, presentations and patents.
  • Manage interactions and contribute to a high level of collaboration with internal and external stakeholders.
  • Adhere to Quality metrics, Compliance and Good Documentation Practices following ALCOA+ principles, GLP, OQM, HSE and ISEC guidelines.

**Key Requirements**

  • PhD in analytical chemistry or equivalent and a minimum 6 years experience, or M. Pharma/M. Sc with a minimum of 12 years experience in the pharmaceutical industry in analytical research and development.
  • Experience in driving analytical activities in NCE across various phases of drug development, complex injectables, parenteral, oligonucleotides, peptides and late phase method validation.
  • Good knowledge of software and computer tools such as Office package, LIMS, chromatography data-evaluation software etc.
  • Fluent English (oral and written).
  • GMP experience in an analytical laboratory.
  • Successfully demonstrated expertise in a specific scientific/technical area.
  • Good presentation skills and scientific/technical writing skills.
  • Good communication skills.

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