Senior Research Scientist

2 weeks ago

Athlone, County Westmeath, Ireland beBeeBiopharmaceutical Full time €94,441 - €113,728
About the Role

We are seeking a skilled Technical Lead to oversee regulatory and scientific development and stability projects in our Biopharmaceutical Laboratory.

  • This is a technical leadership position based at our Analytical GMP facility in Athlone, Ireland.

Key Responsibilities:

  • Independently conducts analytical testing, method optimization/validation, and/or speciality technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in various formulations and/or delivery systems.
  • Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
  • Prepares and reviews study protocols, project status reports, final study reports and other project-related technical documents.
  • Communicates data and technical issues to clients on a weekly basis (or as needed).
  • Provides technical mentorship and training to staff.
  • Leads analytical (procedural and instrumental) troubleshooting sessions.
  • Assists in preparation and implementation of SOPs and quality systems.
  • Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP).
Requirements

To be successful in this role, you will require:

  • A degree or equivalent in Chemistry or Biochemistry.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
  • Knowledge of general chemistry, biochemistry techniques (Western Blot, total protein by BCA or micro BCA assay, ELISA, HPLC/UPLC).
  • Proven experience of method development of identity and purity assays by Western Blot.
  • Ideally experience in leading CMC studies for biopharmaceutical products including method validation.
  • Proficiency on technical operating systems (including Image Lab software).
  • Proven problem solving and troubleshooting abilities.
  • Ability to independently perform root cause analysis for method investigations.
  • Proven ability in technical writing skills.
  • Time management and project management skills.
  • Good written and oral communication skills.
  • Ability to work in a collaborative work environment with a team.
  • Ability to train junior staff.
Working Environment

This role involves:

  • Communication with diverse groups of people in a comprehensible and reasonable manner.
  • Working upright and stationary and/or standing for typical working hours.
  • Lifting and moving objects up to 25 pounds.
  • Working in non-traditional work environments.
  • Using and learning standard office equipment and technology with proficiency.
  • Exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

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