AGC Biologics
biopharmaceutical
Teamlead(f/m/d)MSAT/ProcessValidation
“Teamlead (f/m/d) - MSAT / Process Validation at AGC Biologics. Skills: MSAT Team Lead, Process Validation (PV), Continued Process Verification (CPV), Technology Transfer, bioprocess engineering, Team Leadership. Lead, mentor, and develop a high-performing team of MSAT specialists. Drive the efficiency, structure, and continuous improvement of the group's operations”
What You'll Achieve.
bringing new client projects to life, guiding them from technology transfer to successful GMP manufacturing; ensure our processes are robust and continuously improved throughout their entire lifecycle; Drive the efficiency, structure, and continuous improvement of the group's operations; ensure seamless integration; meet ambitious deadlines
Industry & Context.
risk analysis; deviation investigations; scientific assessments for change controls
What They're Looking For.
Must Have
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, Deep expertise in Good Manufacturing Practices (GMP), Thorough understanding of applicable regulations (e. g. , ICH Q7A, 21 CFR Part 211), Extensive hands-on experience in Process Validation (PV) and Continued Process Verification (CPV), background in bioprocess engineering, including process design, fermentation, and chromatography, Proven track record of authoring, reviewing, and approving formal GMP documentation, Demonstrated success in leading technical teams, 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, Proficiency with statistical software (e. g. , JMP)
Nice to Have
Knowledge in regulatory filings and submissions
What You'll Do.
and develop a high-performing team of MSAT specialists
and continuous improvement of the group's operations
Act as the primary technical lead for transferring complex bioprocesses from clients or other AGC sites
Conduct thorough manufacturability assessments
including process design
to ensure seamless integration
Oversee all Process Validation (PV) activities
from planning and execution to final reporting
Champion Continued Process Verification (CPV) and process optimization initiatives
Provide scientific expertise for process characterization studies
Serve as a key technical point of contact for our clients
confidently leading communications and supporting on-site visits
Prepare and support the technical sections of regulatory dossiers
Actively participate in health authority audits and inspections
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
How You'll Work.
Team & Collaboration
Partner with the Business Development team; coordinating across departments; build effective working relationships with both internal teams and external partners
Communication Scope
Excellent communication and stakeholder management skills; leading communications
Process & Methodology
manage multiple complex projects simultaneously, coordinating across departments, meet ambitious deadlines
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