Senior Aseptic Scientist: Contamination & Process Lead

SallyQ AB

Uppsala kommun

On-site

SEK 900,000 - 1,200,000

Full time

14 days+
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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

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

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