Expertise in Process Development and Transfer

1 day ago

Dublin, Dublin City, Ireland beBeeBioprocessing Full time €70,000 - €105,000
Job Title: Technical Process Specialist

The Technical Process Team is seeking a skilled professional with expertise in process development, late-stage characterization, and technical transfer. This role will be responsible for supporting commercial manufacturing and technology transfers to our drug substance manufacturing facility.

Key Responsibilities:

  • Support commercial manufacturing by investigating, improving, and scaling up processes.
  • Perform and execute facility fits, mass balance generation, equipment sizing, and gap assessments to ensure seamless process transfers.
  • Provide strategic input into facility and equipment design, and prepare, review, and execute technology transfer protocols.
  • Author and review regulatory documents, including health authority query responses.

Requirements:

  • Minimum 3-6 years of experience in process development, late-stage characterization, and technical transfer.
  • Proven knowledge of technical transfer, facility fit, equipment sizing, and mass balance generation.
  • Knowledge of cGMP regulatory requirements and regulatory submissions.

Skills:

  • High technical capability and problem-solving skills.
  • Excellent interpersonal and communication skills.
  • Ability to work in a multi-disciplinary team environment.

Keywords: Bioprocessing, Drug Substance, Proteins, Vaccines

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