AGC Biologics
Contract Development and Manufacturing Organization
SeniorScientist,QCStability
“Senior Scientist, QC Stability at AGC Biologics. Skills: stability expertise, scientific expert, customer collaboration, stability strategies. designing and delivering high-quality stability programs tailored to their products and regulatory needs. act as a scientific expert/SME and trusted partner, helping customers navigate stability strategies across the product lifecycle”
What You'll Achieve.
high-quality stability programs; timely stability programs; high-quality, compliant, and timely stability programs; timely delivery of stability data and reports
Industry & Context.
solving complex challenges
What They're Looking For.
Must Have
stability studies in a GMP-regulated environment, knowledge of stability requirements for DS/DP, knowledge of relevant guidelines (ICH, EU, FDA)
Nice to Have
experience working in a CRO, CDMO or other customer-facing environments, ability to manage multiple projects and stakeholders simultaneously, demonstrated experience in driving continuous improvement and/or productivity programs
What You'll Do.
designing and delivering high-quality stability programs tailored to their products and regulatory needs, act as a scientific expert/SME and trusted partner, helping customers navigate stability strategies across the product lifecycle, Leading the design, planning and execution of customer-specific stability programs for drug substance (DS) and drug product (DP), Acting as a scientific advisor to customers on stability strategies, study design, and regulatory expectations, Writing and reviewing stability protocols, reports and quality documentation (e.
CRs, deviations, CAPAs), Managing customer interactions, including meetings, scientific discussions and expectation alignment, Ensuring timely delivery of stability data and reports in line with agreed timelines and quality standards, Overseeing testing at external laboratories, Ensuring cGMP compliance with relevant guidelines (ICH, EU, FDA) across all activities, Represent stability during audits and inspections and support response to health authority queries (e.
FDA, EMA), Drive continuous improvement initiatives within stability processes, Mentoring junior scientists and contributing to a scientific team environment.
How You'll Work.
Team & Collaboration
ongoing collaborations with stakeholders such as customers, project managers, management, your own department, and QA; collaborative and supportive QC team; knowledge sharing; team sparring and supporting each other
Communication Scope
excellent communication skills in English, both written and spoken
Process & Methodology
manage multiple projects and stakeholders simultaneously
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