Sr Manufacturing Scientist

Sr Manufacturing Scientist

Galderma

Uppsala, Sweden

Job Description

As a Senior Manufacturing Scientist-Aseptic Process, you will serve as a subject matter expert for aseptic manufacturing processes and contamination control. You will provide scientific and technical leadership across critical aseptic operations.

You will work cross-functionally to support routine operations, troubleshoot complex process challenges, lead investigations, and drive continuous improvement initiatives. A key part of the role will be leading the site's media fill program, supporting contamination control strategies, and ensuring compliance with evolving regulatory expectations, including EU GMP Annex 1 and global health authority requirements.

Key Responsibilities

• As the technical expert for aseptic manufacturing, you will provide scientific oversight and support aseptic manufacturing operations, including compounding, filtration, and filling processes.
• You will lead and drive the site's media fill or Aseptic process simulation (APS) program, including design, execution, evaluation, and reporting, ensuring timely investigation and implementation of effective CAPAs to strengthen sterility assurance.
• You will lead and support the Contamination Control Strategy (CCS) by performing scientific risk assessments and ensuring alignment across facility design, HVAC, environmental monitoring, cleaning and disinfection, and aseptic practices.
• You will lead and support complex deviation investigations, root cause analyses, and CAPA activities related to aseptic processes.
• In addition, you will design and evaluate smoke studies to verify airflow performance and first-air protection.
• As a trusted SME, you will collaborate extensively with cross-functional stakeholders and support audits, inspections, technology transfers, process improvements, and implementation of new manufacturing technologies.

Key Requirements & Qualifications

You hold a Bachelor's, Master's, or PhD degree in a relevant scientific or engineering discipline such as Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field. In addition, you bring several years of experience working within a biopharmaceutical or highly regulated manufacturing environment.

You have strong expertise in aseptic processing, contamination control, media fills, and GMP-regulated manufacturing operations. You are comfortable leading investigations, performing risk assessments, and solving complex manufacturing challenges.

To be successful in this role, you should also possess:

• Strong knowledge of aseptic manufacturing processes, contamination control, and sterility assurance principles.
• Experience working with EU GMP, Annex 1 requirements, and regulatory expectations for sterile manufacturing.
• Proven experience leading deviation investigations, root cause analyses, and CAPA implementation.
• Excellent analytical, problem-solving, and technical writing skills.
• Strong stakeholder management and collaboration abilities across multiple functions.
• The ability to independently manage complex projects and drive continuous improvement initiatives.

Experience with Lean, Six Sigma, process optimization, automation, validation activities, or technology implementation projects will be considered highly advantageous.