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Senior Manager Bio-Analytical Development

Location: Dublin, Republic of Ireland
Salary: Negotiable
Posted: 4 months ago
Role type: Permanent
Industry: Science, Technology and Operations Practice (STO), Science Leaders & Specialists
Contact name: Shane Browne
Contact email: shane.browne@hrmrecruit.com

Job description

This innovative global biotech organisation is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. A biotechnology pioneer since 1980, this business has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Due to continued expansion a new position has arisen at the site for a individual contributor sitting at Senior Manager providing bioanalytical expertise to the site with regards to method transfer, troubleshooting, investigations and some method development.

 

The Role

  • Technical leadership in support of troubleshooting method related issues, incoming method transfer and commercial investigations
  • Independent authorship technical reports and answers to analytical questions from health authorities
  • Implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterisation/optimisation, investigations, and regulatory submissions
  • Generating, analysing, and critical evaluation of analytical data to support product development investigations, and regulatory submissions
  • May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by providing analytical updates, analytical documentation and data interpretation
  • Provides mentoring and expertise to less-experienced staff
  • Duties may include establishing timelines, milestones, methodological approaches, expected results, and necessary resources
  • Keeping current in the analytical development field including literature and technology development for cutting edge and regulatory driven activities

 

The Person

  • Doctorate degree in life sciences or related discipline and 2 years of scientific experience OR master's degree in life sciences or related discipline and 5 years of scientific experience OR bachelor's degree in life sciences or related discipline and 7 years of scientific experience
  • Proven technical leader with advanced understanding and experience with various analytical platforms such as chromatography, CE, general assays (e.g. pH, osmolality, Karl Fisher titration, etc.), gels, bioassays and immunoassays
  • Experience in developing, implementing and commercialising methods for in-process, process characterisation, and release testing
  • Experience with method qualification/validation

 

To learn more about this role apply online or call Shane Browne on + 353 1 6321865 for a confidential discussion.

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Shane Browne

Director - Science & Engineering

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