AGC Biologics

Teamlead (f/m/d) - MSAT / Process Validation

Stellenbeschreibung:

Overview

In this role, you lead the MSAT Process Development team to enable technology transfer and GMP manufacturing at our Heidelberg site. You drive scientific excellence, oversee lifecycle management of bioprocesses, and guide client projects from transfer to market. You’ll act as a technical bridge to clients and regulators, ensuring robust, compliant processes and continuous improvement. You’ll thrive in a collaborative, international environment that values impact and professional growth.

Leistungen / Benefits
  • competitive compensation package
  • significant opportunities for professional development
  • collaborative, international work environment
  • opportunity to shape and grow a leading team
  • focus on life-changing therapies
  • core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork
Verantwortungsbereiche
  • Lead and develop a high-performing MSAT team and drive continuous improvement of operations
  • Serve as the primary technical lead for technology transfer of complex bioprocesses and assess manufacturability and facility fit
  • Oversee PV activities and CPV programs, support process characterization and ongoing optimization
  • Act as technical point of contact for clients, support regulatory dossiers, and participate in health authority audits
  • Collaborate with Business Development to assess feasibility of new client proposals; support GMP manufacturing through deviation investigations, change controls, and equipment user requirements
Zentrale Anforderungen
  • Master's degree in a relevant scientific discipline with ≥5 years in industry, or PhD with ≥3 years in a cGMP environment
  • Strong GMP knowledge and understanding of ICH Q7A, 21 CFR Part 211
  • Hands-on PV and CPV experience; background in bioprocess engineering (design, fermentation, chromatography)
  • Proven track record with GMP documentation; leadership and project management experience
  • Excellent communication and stakeholder management; ability to coordinate across departments and with external partners
  • Proficiency with MS Office and JMP; regulatory filings knowledge is preferred
  • leadership & talent development
  • cross-functional collaboration
  • strong communication
  • Process Validation (PV)
  • Continued Process Verification (CPV)
  • bioprocess engineering (fermentation, chromatography)
NOTE / HINWEIS:
EnglishEN: Please refer to Fuchsjobs for the source of your application
DeutschDE: Bitte erwähne Fuchsjobs, als Quelle Deiner Bewerbung

Stelleninformationen

  • Veröffentlichungsdatum:

    14 Sep 2026
  • Standort:

    Heidelberg
  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt

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