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Aseptic Process Specialist

2 weeks ago

Uppsala, Uppsala, Sweden Galderma Full time

We are seeking a highly skilled Aseptic Process Specialist to join our Biologics team within Manufacturing Science and Technology. In this role, you will be responsible for developing and implementing aseptic process simulation (APS) and aseptic process validation, ensuring seamless integration of new products into our manufacturing processes.

Key Responsibilities:

  • Develop and implement APS strategies, ensuring efficient and effective transfer of aseptic processes from development to manufacturing.
  • Collaborate with cross-functional teams to ensure process validation, including documentation, execution, and review of process validation data.
  • Serve as a technical subject matter expert (SME) representing MS&T in Technology Transfer projects.
  • Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards.

Requirements:

  • Bachelor's degree in a relevant scientific or engineering field, such as Chemistry, Biochemistry, Chemical Engineering, or a related discipline.
  • Prior manufacturing experience within the biopharmaceutical industry, with a minimum of 6 years of experience in a biopharmaceutical or manufacturing environment.
  • Experience in drug substance and/or drug product manufacturing within a GMP environment.
  • Previous experience of aseptic filling and visual inspection.

About Us:

At Galderma, we are committed to delivering high-quality products and services that meet the evolving needs of consumers and patients worldwide. Our portfolio includes a range of innovative dermatological products and services, designed to address various skin-related conditions and improve patient outcomes.