MSAT Director

Discover International; Frankfurt; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

A leading biotechnology firm is seeking a Director of Manufacturing Science & Technology (MSAT) in Frankfurt, Berlin, or Munich. This senior role demands robust oversight of late-stage development and commercial manufacturing for biologic products, ensuring compliance and process robustness. Ideal candidates will have an advanced degree, extensive experience in MSAT, and a proven track record in technology transfer and regulatory-aligned support. Relocation support is available for EU work permit holders.

Qualifikationen

• Significant experience in MSAT and commercial biologics manufacturing is essential.
• Strong track record in technology transfer and regulatory compliance.

Aufgaben

• Own the MSAT technical strategy for assigned products.
• Lead technology transfer and process validation activities.
• Provide technical oversight of commercial manufacturing operations.
• Support regulatory submissions and inspections.

Kenntnisse

Technology transfer

Process validation

Regulatory-aligned manufacturing support

Ausbildung

Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline

Jobbeschreibung

Director, Manufacturing Science & Technology (MSAT)

Location: Munich, Berlin, or Frankfurt

Relocation support: Available for EU work permit holders

Role Overview

This Director-level MSAT role provides senior technical leadership across late-stage development and commercial manufacturing for complex biologic products. The position acts as a key technical authority, ensuring process robustness, regulatory alignment, and effective lifecycle management from launch through post-approval.

The role operates in a matrix environment, working closely with Quality, Regulatory, Supply Chain, and external manufacturing partners to support successful commercialization of biologic modalities, including nucleic acid- and antibody-based products.

Key Responsibilities

• Own the MSAT technical strategy for assigned products across late-stage development and commercial manufacturing.
• Lead technology transfer, process validation, control strategy implementation, and launch readiness activities.
• Provide technical oversight of commercial manufacturing, including performance monitoring and issue resolution.
• Support regulatory submissions, inspections, Annual Product Reviews, and responses to health authority questions.
• Lead post-approval lifecycle activities, including change management and continuous improvement initiatives.
• Act as a technical interface with internal teams and external manufacturing partners, proactively identifying and mitigating product and process risks.

Candidate Profile

• Advanced degree (Master’s or PhD) in a relevant scientific or engineering discipline.
• Significant experience in MSAT, late-stage development, and commercial biologics manufacturing.
• Strong track record in technology transfer, validation, and regulatory-aligned manufacturing support.

If this role seems interesting, please send your CV to [e-mail]