Associate Director CMC Excellence & Strategy (Remote)

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This is a highly visible position with significant interaction with senior leadership and programme teams.

Key Responsibilities • Develop and implement CMC strategies across a portfolio of biologics programmes from early development through commercial readiness • Partner with Technical Development teams to establish robust development plans that align with regulatory expectations and business objectives • Drive CMC operational excellence initiatives, improving consistency, governance, and decision-making across the organisation • Lead cross-functional CMC strategy discussions involving Process Development, Analytical Development, Manufacturing, Regulatory Affairs, Quality, Clinical Supply, and Supply Chain • Evaluate development risks and create mitigation strategies to support successful programme execution • Build CMC roadmaps covering process development, analytical strategy, comparability, control strategy, validation, and lifecycle management • Support selection, oversight, and strategic management of CDMOs and external manufacturing partners • Develop governance frameworks, stage-gate processes, and best practice methodologies for CMC execution • Ensure alignment of technical activities with global regulatory requirements including FDA, EMA, MHRA, and ICH guidelines • Provide strategic input into regulatory submissions including INDs, IMPDs, BLAs, and MAAs • Support due diligence activities, business development initiatives, and portfolio assessments where required • Drive continuous improvement initiatives across CMC functions and promote a culture of technical excellence Experience • Bachelor's, Master's or PhD in Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline • Significant experience within CMC, Technical Development, Pharmaceutical Development, Process Development, or Manufacturing Sciences • Experience developing CMC strategies for biologic products • Strong understanding of biologics development from preclinical or clinical stages through commercialisation • Experience working within multidisciplinary project teams • Excellent understanding of global CMC regulatory requirements • Proven ability to influence senior stakeholders and drive strategic initiatives • Strong programme management and organisational skills Key Competencies • Strategic thinking with a strong scientific foundation • Cross-functional leadership • CMC programme planning • Technical decision-making • Regulatory strategy • Risk management • Stakeholder engagement • Change management • Operational excellence • Continuous improvement Associate Director CMC Excellence & Strategy (Remote) This role must be located in Germany About the Opportunity We are partnering with an innovative biopharmaceutical organisation to appoint a Associate Director CMC Excellence & Strategy.

This is a highly strategic role that will shape the company's Chemistry, Manufacturing and Controls (CMC) capabilities across a diverse biologics portfolio.

Rather than owning day-to-day manufacturing operations, you will be responsible for defining and driving CMC strategy, establishing best practices, improving operational excellence, and ensuring programmes are positioned for successful clinical development and commercialisation.

We are open to candidates from any biologic modality, including monoclonal antibodies, recombinant proteins, antibody-drug conjugates (ADCs), cell therapy, gene therapy, mRNA, viral vectors, vaccines, oligonucleotides, or other advanced therapeutics.

The Role As the CMC Excellence & Strategy lead, you will work across Technical Development, Pharmaceutical Development, Manufacturing, Regulatory Affairs, Quality, Supply Chain, and external CDMO partners to develop robust CMC strategies that support pipeline progression and long-term business objectives.

You will identify opportunities to standardise processes, strengthen governance, optimise development strategies, and improve execution across multiple programmes.