Senior Manufacturing Scientist Position for Regulatory Compliance and Process Optimization

3 days ago

Uppsala, Uppsala, Sweden SallyQ Full time

About the Role:

The position of Senior Manufacturing Scientist at Galderma involves serving as a subject matter expert (SME) responsible for new product implementation into a manufacturing facility, and for support of upstream processes and assembly and packaging processes during commercial manufacturing.

You will be part of a team and collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and process development, to ensure thorough investigation and perform risk assessments.

Key Responsibilities:
  • Process Validation: Develop NPI strategy and support all aspects of process validation, including writing process validation documentation, executing process validation, performing process data reviews, investigations, risk management, and change implementation.
  • SME Representation: Serve as SME representing MS&T in Technology Transfer projects.
  • Process Ownership: Process owner to support day-to-day operations with a focus on continuous improvements. Identify opportunities for process enhancement, cost reduction, and efficiency gains, proactively driving necessary changes.
  • Investigation and Root Cause Analysis: Lead and participate in investigations of deviations, incidents, and anomalies within the manufacturing process. Conduct in-depth root cause analysis to identify the underlying reasons for deviations and incidents, focusing on process improvement. Provide SME assessments in investigations and change controls as required. Prepare detailed investigation reports, conveying findings and recommendations to management and relevant stakeholders.
  • Data Collection and Analysis: Collect and analyze data from various sources, including quality control reports, production logs, and other relevant documents, to support investigations and continuous process verification (CPV).
  • Maintenance of Records: Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards.
  • Technical Documentation: Write technical manufacturing documentation and dossier sections and provide responses to regulatory authorities as needed.

This is a permanent position with a 6-month probation period based in Uppsala. The employment contract will be directly with Galderma.

To succeed in this role, you need a BSc or MSc in a relevant scientific or engineering field and solid experience from relevant work. We work in a fast-paced environment where proactivity and taking responsibility are essential.

Requirements:

  • Bachelor's or master's degree in a relevant scientific or engineering field
  • Approximately 6 years of experience in a biopharmaceutical or medical device
  • Knowledge of regulatory requirements related to investigations and cGMP
  • Strong knowledge of investigative methodologies and root cause analysis techniques
  • Experience from either downstream packaging manufacturing environment or upstream manufacturing environment, preferably with sterilization knowledge
  • Proficiency in data collection, analysis, and reporting
  • Proficient in English, with Swedish as a plus

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