Director, MSAT Antibodies (Manufacturing Science & Technology)
Location: Can be based in Munich, Berlin or Frankfurt
Can support relocation for EU permit holders only
Overview
This Director-level MSAT role provides technical leadership across late-stage development and commercial manufacturing, acting as a key technical authority for complex biologic products. The position plays a critical role in ensuring robust process performance, regulatory alignment, and effective lifecycle management from launch through post-approval.
The role operates in a matrix environment, partnering closely with Quality, Regulatory Affairs, Supply Chain, and external manufacturing partners to support successful commercialization and ongoing compliance of biologic products, including Nucleic Acid and antibody based modalities.
Key Responsibilities
* Act as the technical voice of the product within MSAT, ensuring alignment with regulatory filings and commercial manufacturing strategies.
* Define and execute MSAT strategies supporting late-stage development, technology transfer, and commercial manufacturing.
* Ensure technical approaches align with global regulatory expectations and quality standards
* Lead late-stage and commercial technology transfers to internal and external manufacturing sites.
* Drive process validation, control strategy implementation, and launch readiness activities.
* Support preparation and execution of late-stage regulatory submissions and manufacturing readiness activities.
* Provide technical oversight of commercial manufacturing, including process monitoring and performance trending.
* Lead or support GMP investigations, deviations, and root cause analyses, ensuring timely and compliant resolution.
* Oversee Annual Product Reviews and contribute to responses to regulatory questions.
* Lead post-approval lifecycle activities, including technical change assessments and implementation of change management plans.
* Identify opportunities for process improvements while maintaining regulatory compliance.
* Act as a matrix product lead within MSAT, providing technical direction, coaching, and mentorship to MSAT teams.
* Ensure effective communication and alignment across MSAT, Quality, Regulatory, and Supply organizations.
* Serve as a technical interface with external manufacturing and development partners.
* Support governance and alignment with strategic partners on technical, quality, and regulatory topics.
* Proactively identify and mitigate technical and product risks across the manufacturing lifecycle.
* Drive continuous improvement initiatives to enhance process robustness and manufacturing performance.
Candidate Profile
* Advanced degree (Master’s or PhD) in Biotechnology, Biochemistry, Chemical Engineering, or a related scientific discipline.
* Extensive experience in MSAT, late-stage development, and commercial biologics manufacturing.
* Proven leadership in technology transfer, process validation, and commercial manufacturing support.
* Strong understanding of biologic modalities, control strategies, and regulatory expectations.