Biologics Development Specialist

2 days ago


Dublin, Dublin City, Ireland beBeeBiologics Full time €60,000 - €85,000
Biologics Development Specialist

This role requires a skilled professional with extensive experience in biologics drug substance manufacturing and microbiological testing techniques.

Key Responsibilities:
  • Oversee laboratory operations, including equipment qualification, documentation generation, and SME review of SOPs and work instructions.
  • Lead trending and reporting of laboratory data to support batch release and maintain oversight of review metrics.
  • Maintain and release laboratory stock, ordering laboratory consumables as needed.
  • Participate in functional meetings, leading departmental and cross-functional meetings as required.
  • Support internal and external audit and inspection activities, ensuring permanent inspection readiness.
  • Perform supporting GMP activities and troubleshooting for general lab operations, EM, and facility testing.
  • Execute in-process and drug substance analysis studies and lead/participate in laboratory projects.
  • Collaborate with the global Microbiology Center of Expertise and participate in lean lab methodologies.
Requirements:
  • Relevant degree qualification (Biological Sciences/Engineering) preferably with a background in microbiology.
  • Advanced Degree (e.g., MSc) qualification desirable.
  • Extensive experience working in a relevant industry field.
  • Ability to work as part of a team and on own initiative in a constructive manner.
  • Technical knowledge with biologics drug substance manufacturing and microbiological testing techniques.
  • Logical thinking and ability to be proactive under pressure.
  • Effective communicator.


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