Biologics Manufacturing Specialist

5 days ago


Uppsala, Uppsala, Sweden Galderma Full time

Galderma, the emerging leader in dermatology, operates in over 90 countries. We deliver a portfolio of premium brands and services across the full spectrum of the fast-growing dermatology market through Injectables, Skincare, and Therapeutic Dermatology.

Job Title: Senior Manufacturing Scientist, BiologicsAbout the Role:

This position is responsible for implementing new product manufacturing processes and supporting commercial production within the Biologics team.

Key Responsibilities:
  1. Develop a comprehensive strategy for new product implementation, encompassing process validation, documentation, execution, data review, risk management, and change implementation.
  2. Serve as a subject matter expert representing MS&T in Technology Transfer projects, ensuring seamless transition of knowledge and expertise.
  3. Process owner to support day-to-day operations with a focus on continuous improvements, identifying opportunities for enhancement, cost reduction, and efficiency gains, driving necessary changes proactively.
  4. Lead and participate in investigations of deviations, incidents, and anomalies within the manufacturing process, conducting root cause analysis to identify underlying reasons, focusing on process improvement.
  5. Collect and analyze data from various sources, including quality control reports, production logs, and relevant documents, to support investigations and continuous process verification.
  6. Design and execute technical runs/design of experiments (DoE) with data analysis and recommendations.
  7. Maintain detailed records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards.
  8. Develop and provide technical manufacturing documentation and dossier sections, responding to regulatory authorities as needed.
  9. Coordinate and collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and process development, to ensure thorough investigation and timely issue resolution.


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