Senior Manufacturing Scientist – Aseptic Processing, Galderma (Uppsala)

SallyQ AB; Uppsala kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Galderma is seeking a Senior Manufacturing Scientist – Aseptic Processing to lead aseptic operations at our Uppsala site. You will oversee media fills, contamination control, and risk-based improvement programs while ensuring EU GMP Annex 1 compliance.

This role requires on-site presence up to four days per week and collaboration across cross-functional teams. You bring advanced degrees in a related field and a proven track record in regulated manufacturing, with strong analytical and technical

Qualifications

• Bachelor's, Master's, or PhD in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field with several years of experience in a biopharmaceutical or other highly regulated manufacturing environment.
• Strong expertise in aseptic processing, contamination control, media fills, and sterility assurance principles within GMP-regulated operations.
• Experience with EU GMP, Annex 1 requirements, and regulatory expectations for sterile manufacturing.
• Proven track record leading deviation investigations, root cause analyses, and CAPA implementation.
• Excellent analytical, problem-solving, and technical writing skills.
• Strong stakeholder management and collaboration across multiple functions.
• Ability to independently manage complex projects and drive continuous improvement initiatives.

Responsibilities

• Provide scientific oversight and technical expertise across aseptic manufacturing operations, including compounding, filtration, and filling processes.
• Lead the site's media fill / Aseptic Process Simulation (APS) program: design, execution, evaluation, reporting, and timely CAPA implementation to strengthen sterility assurance.
• Lead and support the Contamination Control Strategy (CCS) through scientific risk assessments spanning facility design, HVAC, environmental monitoring, cleaning and disinfection, and aseptic practices.
• Lead complex deviation investigations, root cause analyses, and CAPA activities related to aseptic processes.
• Design and evaluate smoke studies to verify airflow performance and first-air protection.
• Act as a trusted SME in audits, inspections, technology transfers, process improvements, and the implementation of new manufacturing technologies.
• The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week.

Skills

Aseptic processing

Contamination control

Media fills

CAPA

Root cause analysis

GMP regulations

Stakeholder management

Technical writing

Project management

Education

PhD/Master's/Bachelor's in Chemistry/Pharmac Sciences/CE/Biochemistry

Job description

We’re looking for a passionate and driven Senior Manufacturing Scientist – Aseptic Processing to join our Manufacturing Science & Technology (MS&T) team in Uppsala and play a critical role in ensuring the robustness, compliance, and continuous improvement of our aseptic manufacturing processes. At Galderma, we’re not just offering a job, we’re inviting you to be part of something bigger.

About the Role

You serve as the site's subject matter expert for aseptic manufacturing and contamination control, providing scientific and technical leadership across critical aseptic operations. You work cross-functionally to support routine operations, troubleshoot complex process challenges, lead investigations, and drive continuous improvement. A key part of the role is leading the site's media fill program and contamination control strategy, and ensuring compliance with evolving regulatory expectations, including EU GMP Annex 1 and global health authority requirements.

Key Responsibilities

• Provide scientific oversight and technical expertise across aseptic manufacturing operations, including compounding, filtration, and filling processes.
• Lead the site's media fill / Aseptic Process Simulation (APS) program: design, execution, evaluation, reporting, and timely CAPA implementation to strengthen sterility assurance.
• Lead and support the Contamination Control Strategy (CCS) through scientific risk assessments spanning facility design, HVAC, environmental monitoring, cleaning and disinfection, and aseptic practices.
• Lead complex deviation investigations, root cause analyses, and CAPA activities related to aseptic processes.
• Design and evaluate smoke studies to verify airflow performance and first-air protection.
• Act as a trusted SME in audits, inspections, technology transfers, process improvements, and the implementation of new manufacturing technologies.
• The role is based at Galderma's production site in Uppsala and requires on-site presence up to four days per week.

Your Profile

You’re a curious, proactive, and scientifically minded professional who enjoys solving complex challenges and driving improvement in highly regulated manufacturing environments. You take ownership naturally, influence stakeholders with confidence, and navigate complexity while keeping compliance and continuous improvement front of mind.

Qualifications

• Bachelor's, Master's, or PhD in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline, with several years of experience in a biopharmaceutical or other highly regulated manufacturing environment.
• Strong expertise in aseptic processing, contamination control, media fills, and sterility assurance principles within GMP-regulated operations.
• Experience with EU GMP, Annex 1 requirements, and regulatory expectations for sterile manufacturing.
• Proven track record leading deviation investigations, root cause analyses, and CAPA implementation.
• Excellent analytical, problem-solving, and technical writing skills.
• Strong stakeholder management and collaboration across multiple functions.
• Ability to independently manage complex projects and drive continuous improvement initiatives.