Senior QC Analytical Scientist – Remote/Hybrid

FUJIFILM Biotechnologies; Hillerød; Presencial; DKK 800.000 - 1.100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Massage and physiotherapy

Health check

Fitness center

Work from home

Canteen and Friday brunch

Descripción de la vacante

FUJIFILM Biotechnologies Denmark in Hillerød is seeking a scientist for the QC Analytical Development team to lead the implementation and transfer of analytical methods in support of tech transfer and release. You will author and review protocols, validate methods, and support audits.

Candidates hold MSc or PhD in Pharmaceutical Sciences with 5+ years in pharma/biotech, strong GMP knowledge, experience with JMP and method transfers, and excellent English.

Formación

• MSc or PhD degree within Pharmaceutical Sciences, Biochemistry, Biotechnology, or other relevant fields with at least 5 years of pharma/biotech experience, preferably QC
• Familiar with GXP guidelines, USP, EP and ICH guidelines
• Broad analytical background and experience with several analytical methods; knowledge of JMP or other statistical software
• Experience with method transfers and validations is a clear advantage
• Proficiency in written and spoken English

Responsabilidades

• Author and review transfer, qualification and validation protocols, reports and SOPs
• Data analysis and data evaluation, including method troubleshooting
• Handing over transferred and validated methods to QC testing teams
• Analytical method support to QC testing teams, including OOS investigations
• Change control assessments for method or specification changes
• Support validation and implementation of new instruments with QC Instrument Supporting team
• Ensure compliance with cGMP and participate in audits/inspections as needed

Educación

MSc or PhD in Pharmaceutical Sciences

Herramientas

JMP

Descripción del empleo

FUJIFILM Biotechnologies Denmark in Hillerød is seeking a scientist for the QC Analytical Development team to lead the implementation and transfer of analytical methods in support of tech transfer and release. You will author and review protocols, validate methods, and support audits.

Candidates hold MSc or PhD in Pharmaceutical Sciences with 5+ years in pharma/biotech, strong GMP knowledge, experience with JMP and method transfers, and excellent English.