Senior Pharmaceutical Process Specialist

10 hours ago

Sligo, Sligo, Ireland beBeeTechnicalTransferScientist Full time €70,000 - €90,000
Job Description">

Our organization is seeking a skilled professional to fill the role of Technical Transfer Scientist. As a key member of our team, you will be responsible for coordinating and executing technical transfer activities.

The successful candidate will have experience in new product introductions (NPI) and production support within the biotechnology and/or pharmaceutical sector. A strong understanding of process validation, particularly in the authoring, reviewing, and execution of reports, is essential.

About the Role

  • Plan and coordinate technical transfer activities to ensure seamless transition of processes and technology.
  • Focus on assigned technical transfer activities for new products and filling and inspection processes being transferred into the site.
  • Develop collaborative relationships with site business units to address technical transfer activity-related issues.
  • Provide on-site process support and enhanced support during engineering runs.
  • Establish statistically based tracking metrics.
  • Investigate and close out non-conformances, planned deviations, and change control requests.
  • Perform sample analysis according to standard operating procedures (SOPs) when required.
  • Coordinate the use of external test laboratories when necessary.
  • Present technical transfer and routine process monitoring findings to cross-functional teams and contribute to developing business cases for courses of action as needed.
Required Skills and Qualifications
  • A Master's degree in a relevant technical discipline, such as biochemistry, chemistry, or biotechnology, is required. A PhD is desirable.
  • Experience in the biotechnology and/or pharmaceutical industry, with operational experience of NPI and product support is essential.
  • Knowledge of manufacturing processes and equipment for pharmaceuticals, including oral solid dose, parenterals, and biologicals.
  • Proven ability in authoring, reviewing, and executing process validation studies and reports.
  • Experience with vaccines is preferable, particularly in product development and stewardship.
  • Cleaning validation experience is desirable.

Benefits

As a valued member of our team, you will enjoy opportunities for professional growth and development. Our organization offers a dynamic work environment that encourages collaboration, innovation, and excellence in all aspects of our operations.

Others

This role requires a flexible and adaptable individual who can thrive in a fast-paced environment. If you are a motivated professional with a passion for scientific excellence, we encourage you to apply for this exciting opportunity.

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