Sr Manufacturing Scientist, Device Injectables

Sr Manufacturing Scientist, Device Injectables

Galderma

Uppsala, Sweden

Job description :

We are looking for a new member to the Device Injectables within Manufacturing Science and Technology. The senior manufacturing scientist is a subject matter expert (SME) responsible for new product implementation (NPI) into a manufacturing facility, and for support of upstream processes during commercial manufacturing.

Key responsibilities:

• 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.
• Serve as SME representing MS&T in Technology Transfer projects.
• 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.
• 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.
• 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).
• Develop and lead execution of technical runs with DoE studies, data analysis and recommendations.
• Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards
• Write technical manufacturing documentation and dossier sections and provide responses to regulatory authorities as needed.
• Coordinate and collaborate with cross-functional teams, including production, quality assurance, regulatory affairs, and process development, to ensure thorough investigation and timely issue resolution. Gather information to support research studies and claims, as well as perform risk assessments/FMEAs.

Skills & Qualifications

• Bachelor’s or master’s degree in a relevant scientific or engineering field
• Minimum 6 years of experience in a biopharmaceutical or medical device upstream manufacturing environment, preferably with sterilization knowledge
• Knowledge of regulatory requirements related to investigations and cGMP
• Strong knowledge of investigative methodologies and root cause analysis techniques.
• Proficiency in data collection, analysis, and reporting

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