Senior Transfer & Stability Manager

K-Recruiting Life Sciences; Bayern; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading life sciences firm in Bayern is hiring a Senior Transfer & Stability Manager. This role involves creating and reviewing transfer plans and reports, supporting transfer partners, and performing risk assessments. The ideal candidate holds a relevant university degree and has several years of experience in a GMP environment, especially within Quality Control. Strong analytical skills and proficiency in English are essential. The position is vital in ensuring compliant product transfers and stability studies.

Qualifikationen

• University degree in a scientific field (Chemistry, Pharmacy, Biochemistry, or equivalent preferred).
• Several years of experience in a GMP environment, ideally in Quality Control (QC).
• Strong knowledge of analytical methods (e.g., HPLC, GC, spectroscopy) and transfer requirements.

Aufgaben

• Create or review transfer plans for analytical method and product transfers.
• Create or review transfer reports, including support with data evaluation.
• Perform and review risk assessments in the context of analytical transfers.

Kenntnisse

Analytical methods

Risk assessments

GMP compliance

Stability studies

Quality Control (QC)

English (spoken and written)

Ausbildung

University degree in Chemistry, Pharmacy, Biochemistry or equivalent

Jobbeschreibung

Senior Transfer & Stability Manager (m/f/d)

Job responsibilities

• Create or review transfer plans for analytical method and product transfers (national and international)
• Create or review transfer reports, including support with data evaluation, GMP-compliant documentation, and final assessment
• Perform and review risk assessments in the context of analytical transfers
• Participate in and contribute to the preparation of transfer and project meetings
• Collect and provide relevant information for transfer partners
• Create or review plans and reports for special stability studies (e.g., in the context of regulatory submissions)
• Support preparation of the “Bulk Stability Studies” project
• Coordinate stability studies together with site personnel

Professional and personal requirements

• University degree in a scientific field (Chemistry, Pharmacy, Biochemistry, or equivalent preferred)
• Several years of experience in a GMP environment, ideally in Quality Control (QC)
• Strong knowledge of analytical methods (e.g., HPLC, GC, spectroscopy) and transfer requirements
• Strong knowledge of stability studies
• Experience in GMP-compliant documentation, deviations, and risk assessments
• Very good English skills (spoken and written)