Analytical QC Analyst / Technology Transfer

Fastnet

Munster

On-site

EUR 60,000 - 85,000

Full time

8 days ago

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Benefits offered by this job

Health insurance

Job summary

Fastnet is seeking an experienced QC Analytical Technology Transfer Analyst with hands-on testing of biologics and large-molecule products within a GMP pharmaceutical environment. The role combines routine QC analytical testing with analytical method transfer, verification and associated technical documentation.

You will collaborate with sending-site QC teams to obtain method packages, reference standards and comparator data, while supporting the planning and coordination of transfer activities.

Qualifications

  • Degree in Biochemistry, Biotechnology, Chemistry, Pharmaceutical Science or related discipline.
  • Approximately 5 years' experience in a GMP-regulated QC laboratory.
  • Experience with biologics or large‑molecule testing and data integrity.

Responsibilities

  • Perform hands-on QC analytical testing of biologics and large‑molecule products per GMP.
  • Prepare, execute and review transfer/verification protocols and reports.
  • Collaborate with sending-site QC teams to obtain method packages and data.
  • Review results, support investigations and contribute to risk assessments and FMEA.

Education

Degree in Biochemistry / Biotechnology / Chemistry / Pharmaceutical Science

Job description

Summary:

We are seeking an experienced QC Analytical Technology Transfer Analyst with strong hands-on experience in biologics and large-molecule testing within a GMP pharmaceutical environment. The role combines routine QC analytical testing with analytical method transfer, verification and associated technical documentation.

Responsibilities:

  • Perform hands-on QC analytical testing of biologics and large-molecule products, including routine testing and analytical method transfer/verification activities, in accordance with GMP requirements.
  • Prepare, execute and review analytical method transfer/verification protocols and reports, ensuring accurate documentation and data integrity.
  • Collaborate with sending-site analytical/QC teams to obtain method packages, reference standards and comparator data, while supporting the planning and coordination of transfer activities.
  • Review analytical results, support investigations into testing discrepancies and contribute to risk assessments and FMEA activities associated with product transfers.

Requirements:

  • Degree in Biochemistry, Biotechnology, Chemistry, Pharmaceutical Science or a related discipline, with approximately 5 years' experience in a GMP-regulated QC laboratory.
  • Strong hands-on analytical testing experience with biologics or large-molecule products, including knowledge of GMP, laboratory documentation and data integrity requirements.
  • Experience supporting analytical method transfer, verification or validation activities, including protocol execution, analytical data review and technical documentation.
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