MSAT Project Lead – Operational Readiness (Drug Substance Facility) (m/f/d)

Overview

We are seeking an experienced MSAT Project Lead to oversee the transition from Commissioning & Qualification (CQ) through Facility Start-up and Operational Readiness at a world-class Drug Substance (DS) manufacturing facility. This multi-year project covers Media/Buffer preparation, Fermentation, Downstream Processing, and associated unit operations—culminating in a seamless, compliant move into GMP production.

This role demands deep, hands-on technical expertise, a strong quality mindset, and proven cross-functional leadership and coaching abilities. You’ll be the bridge between engineering, QA, and broader project stakeholders, ensuring successful operational readiness for large-scale DS manufacturing.

Key Responsibilities

• Lead planning, scheduling, and execution of Facility Start-up & Operational Readiness—from CQ transition to GMP handover
• Oversee qualification and operational readiness for all DS facility processes, with focus on Media/Buffer Preparation, Fermentation, Downstream Processing units, and related equipment
• Prepare, review, and approve all technical quality documents (IQ/OQ/PQ, SOPs, CAPAs, deviations, validation protocols)
• Align and coordinate diverse cross-functional teams on technical and QA priorities
• Act as a hands-on technical expert, troubleshooting complex process and equipment issues
• Proactively engage with stakeholders, listen to requirements, and devise practical solutions
• Foster a collaborative, respectful, and high-performance project environment

Qualifications & Expertise

• Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biotech, or related field)
• Minimum 10 years’ practical experience in MSAT, CQV, QA, or pharmaceutical manufacturing (Drug Substance facility experience required)
• Proven leadership of large, complex, multi-year projects
• Deep technical competence in Media/Buffer Preparation, Fermentation, Downstream Processing, and associated process equipment
• Strong skills in process flow, P&IDs, troubleshooting, and operational readiness
• Experience in technical documentation in GMP settings
• Excellent coaching, communication, and stakeholder management abilities
• Fluent in English; German is a plus but not required

How to Apply

Ready to shape the operational success of a state-of-the-art DS manufacturing facility? Click “Apply” with your CV or LinkedIn profile. Only candidates with directly relevant experience in Drug Substance facility start-up and operational readiness will be considered. For questions, contact