Senior Transfer & Stability Manager

R&D Partners; Pfaffenhofen an der Ilm; Vor Ort; EUR 65.000 - 85.000; Vollzeit

Zusammenfassung

A leading biotechnology firm in Germany is looking for a Senior Transfer & Stability Manager to oversee analytical method transfers and stability studies. This role demands a strong background in natural sciences and experience with GMP environments. Responsibilities include preparing transfer plans, risk assessments, and collaborating with partners on regulatory approvals. Excellent English skills are essential, and candidates must possess relevant analytical method expertise. This position offers an opportunity to significantly impact pharmaceutical breakthroughs.

Qualifikationen

• Background in natural sciences, chemistry, pharmaceutical sciences, biochemistry, or a related field.
• Familiarity with GMP environments, particularly in Quality Control.
• Strong knowledge of analytical methods like HPLC, GC, and spectroscopy.
• Proficiency in handling deviations and conducting risk analyses.
• Excellent English communication skills.

Aufgaben

• Prepare or review plans and reports for transferring analytical methods and products.
• Evaluate data and ensure GMP-compliant documentation.
• Conduct and review risk assessments related to analytical transfers.
• Coordinate and support special stability studies for regulatory approvals.
• Oversee stability studies.

Kenntnisse

Analytical methods knowledge (HPLC, GC, spectroscopy)

Familiarity with GMP environments

Risk analysis proficiency

Excellent English communication skills

Ausbildung

Background in natural sciences or related field

Jobbeschreibung

Are you ready to oversee cutting-edge stability that accelerates pharma breakthroughs in biotech?

R&D Partners is seeking a Senior Transfer & Stability Manager to support analytical method and product transfers, as well as stability studies. This role involves preparing and reviewing transfer plans, reports, and risk assessments while ensuring compliance with GMP standards. You will collaborate with transfer partners, coordinate stability studies, and contribute to regulatory approval processes.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities

• Prepare or review plans and reports for transferring analytical methods and products.
• Evaluate data and ensure GMP-compliant documentation.
• Conduct and review risk assessments related to analytical transfers.
• Participate in and prepare for project and transfer meetings.
• Collect and share information with transfer partners.
• Coordinate and support special stability studies for regulatory approvals.
• Assist in bulk stability study projects and oversee stability studies.

Key Skills and Requirements

• Background in natural sciences, chemistry, pharmaceutical sciences, biochemistry, or a related field.
• Familiarity with GMP environments, particularly in Quality Control.
• Strong knowledge of analytical methods like HPLC, GC, and spectroscopy, including their transfer requirements.
• Understanding of stability studies and related documentation.
• Proficiency in handling deviations and conducting risk analyses.
• Excellent English communication skills, both written and spoken.