Manufacturing Scientist - API Specialist

Manufacturing Scientist - API Specialist

Galderma

Uppsala, Sweden

Job description:

You will enable and maintain robust and reliable manufacturing through right first-time technology transfers, process validations, and new product implementation (NPI) with a focus on milling and sieving manufacturing processes; strong process ownership by turning technologies into manufacturing capabilities by applied science and technical investigations, ensuring continuous process improvements, through consistent methodology.

Key responsibilities:

• Implement plans and programs and support policies and practices related to the end-to-end manufacturing processes of new product introduction (NPI) projects at all stages, from prototyping to final stage, within API process chemistry.
• Enable smooth transition of products from R&D into full production readiness, representing MS&T in Tech Transfer projects.
• Ensure suggested design made by engineering optimizes the production process in terms of process efficiency, cycle time, reliability, and serviceability.
• Support day-to-day operation ensuring continuous improvements.
• Experience with process development and DoE (Design of Experiments). Performing experiments and analysis including gathering and preparing samples. Lead and participate in investigations into deviations, incidents, and anomalies within the API manufacturing process.
• Conduct in-depth root cause analysis to identify the underlying reasons for deviations and incidents, focusing on process improvement.
• Collect and analyze data from various sources, including quality control reports, production logs, and other relevant documents, to support investigations and continuous process verification.
• Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards, including process descriptions and master batch records. Write technical manufacturing documentation and dossier sections.
• Coordinate with other experts and collaborate with cross-functional teams, including quality assurance, regulatory affairs, and process development, to ensure thorough investigation and timely issue resolution. Gather information to support research studies and claims, perform risk assessments/FMEAs. Team management experience.
• Identify opportunities for process enhancement, cost reduction, and efficiency gains, proactively driving necessary changes.
• Write validation documentation and execute process validations.

Skills & Qualifications:

• BSc, MSc, or PhD in a relevant scientific or engineering field, such as Chemistry, Biochemistry, Chemical Engineering, or a related discipline.
• Prior manufacturing process experience within the biopharmaceutical industry with a minimum of 6 years of experience in a biopharmaceutical or manufacturing environment.
• Experience with API and raw material handling would be a strong advantage.

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