QC Development Scientist – Transfers & Validation (Remote)

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 900,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Massage & physiotherapy

Health check

Fitness center

Friday brunch & canteen

Job summary

FUJIFILM Biotechnologies Denmark ApS is seeking a scientist for the QC Analytical Development team in Hillerød. The role focuses on implementing and transferring analytical methods to support technology transfer programs between customers and FUJIFILM Biotechnologies, including cGMP release testing for DS/DP products.

The ideal candidate holds an MSc or PhD in Pharmaceutical Sciences and has at least 5 years in pharma/biotech, with strong knowledge of analytical techniques (UV, icIEF, CE-SDS,

Qualifications

• MSc or PhD in Pharmaceutical Sciences or related field and at least 5 years in pharma/biotech, preferably QC
• Solid understanding of GXP guidelines (US Pharmacopeia, European Pharmacopoeia, ICH)
• Broad analytical background with experience in multiple methods (UV, SDS-PAGE, icIEF, CE-SDS, SEC, CEX, U/HPLC) and data analysis tools
• Experience with method transfers and validations is a clear advantage
• Proficient in written and spoken English

Responsibilities

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

Skills

Analytical methods

English proficiency

GXP knowledge

Method transfer experience

QC environment experience

Education

MSc or PhD in Pharmaceutical Sciences

Tools

JMP

Statistical software

Job description

FUJIFILM Biotechnologies Denmark ApS is seeking a scientist for the QC Analytical Development team in Hillerød. The role focuses on implementing and transferring analytical methods to support technology transfer programs between customers and FUJIFILM Biotechnologies, including cGMP release testing for DS/DP products.

The ideal candidate holds an MSc or PhD in Pharmaceutical Sciences and has at least 5 years in pharma/biotech, with strong knowledge of analytical techniques (UV, icIEF, CE-SDS,