About AGC Biologics
AGC Biologics is a leading global biopharmaceutical contract development and manufacturing organization (CDMO). Our global network spans three continents, with cGMP-compliant facilities in Denmark, U.S., Italy, Germany, and Japan. We currently employ more than 2500 team members worldwide. We collaborate with some of the world's leading and most innovative pharmaceutical companies to develop and manufacture life-changing treatments. We are dedicated to bringing products to market that turn possibilities into reality and bring hope to life for patients around the world. To do so, we provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells.
Your Mission
We are seeking a passionate and experienced leader to join our Process Development team as the MSAT Team Lead. In this pivotal role, you will be the driving force behind bringing new client projects to life, guiding them from technology transfer to successful GMP manufacturing at our Heidelberg site. You will champion scientific excellence, lead a talented team, and ensure our processes are robust and continuously improved throughout their entire lifecycle.
- Team Leadership & Development: Lead, mentor, and develop a high-performing team of MSAT specialists. Drive the efficiency, structure, and continuous improvement of the group's operations.
- Technology Transfer & Process Introduction: Act as the primary technical lead for transferring complex bioprocesses from clients or other AGC sites. Conduct thorough manufacturability assessments, including process design, facility fit, and risk analysis, to ensure seamless integration.
- Process Excellence & Lifecycle Management: Oversee all Process Validation (PV) activities, from planning and execution to final reporting. Champion Continued Process Verification (CPV) and process optimization initiatives, and provide scientific expertise for process characterization studies.
- Client & Regulatory Partnership: Serve as a key technical point of contact for our clients, confidently leading communications and supporting on-site visits. You will prepare and support the technical sections of regulatory dossiers and actively participate in health authority audits and inspections.
- Cross-Functional Collaboration: Partner with the Business Development team to assess the feasibility of new client proposals. Support GMP manufacturing by leading deviation investigations, providing scientific assessments for change controls, and defining user requirements for new process equipment.
- A Master's degree in a relevant scientific discipline with a minimum of 5 years of industry experience, or a PhD with a minimum of 3 years of experience in a cGMP environment.
- Extensive leadership experience, with a proven track record of successfully leading and developing teams.
- Deep expertise in Good Manufacturing Practices (GMP) and a thorough understanding of applicable regulations (e.g., ICH Q7A, 21 CFR Part 211).
Core Technical Competencies:
- Extensive hands-on experience in Process Validation (PV) and Continued Process Verification (CPV).
- Strong background in bioprocess engineering, including process design, fermentation, and chromatography.
- Proven track record of authoring, reviewing, and approving formal GMP documentation.
Leadership & Project Management:
- Demonstrated success in leading technical teams and a passion for developing talent.
- Exceptional ability to manage multiple complex projects simultaneously, coordinating across departments to meet ambitious deadlines.
- Excellent communication and stakeholder management skills, with a proven ability to build effective working relationships with both internal teams and external partners.
- Proficiency with MS Office and statistical software (e.g., JMP) is required.
- Preferred: Knowledge in regulatory filings and submissions.
- A chance to make a tangible impact on bringing life-changing therapies to patients worldwide.
- A key leadership role with strategic responsibility and the opportunity to shape and grow a critical team.
- A collaborative, dynamic, and international work environment where you can live the AGC Biologics Core Values.
- Significant opportunities for professional development and career growth within a leading global Contract Development and Manufacturing Organization (CDMO).
- A competetive compensation package with a base salary of around 80.000 - 100.000 EUR depending on relevant qualification and experience excluding bonuses and other benefits.
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