Associate Director CMC Excellence & Strategy

About the Role

We are collaborating with a pioneering biopharmaceutical company to appoint an Associate Director for CMC Excellence & Strategy based in Germany. This pivotal strategic role will define and propel the Chemistry, Manufacturing, and Controls (CMC) framework across a broad biologics portfolio. The primary focus is not on daily manufacturing operations but on shaping CMC strategy, instituting standard practices, enhancing operational efficiency, and guiding clinical development and commercialization efforts.

The role welcomes candidates experienced with various biologic modalities such as monoclonal antibodies, recombinant proteins, antibody-drug conjugates (ADCs), cell and gene therapies, mRNA, viral vectors, vaccines, oligonucleotides, and other advanced therapeutics.

Key Responsibilities

• Create and enforce CMC strategies for a diverse biologics pipeline from early-phase through to commercial launch readiness.
• Collaborate with Technical Development teams to craft comprehensive development plans aligned with regulatory frameworks and business goals.
• Lead initiatives to elevate operational efficiency in CMC functions, bolstering governance and decision-making consistency across the organization.
• Steer cross-functional CMC strategic deliberations encompassing Process Development, Analytical Development, Manufacturing, Regulatory Affairs, Quality Assurance, Clinical Supply, and Supply Chain functions.
• Analyze development risks and formulate mitigation strategies for seamless programme execution.
• Develop comprehensive CMC roadmaps addressing process and analytical development, comparability, control strategies, validation, and lifecycle management.
• Oversee selection and strategic management of Contract Development and Manufacturing Organizations (CDMOs) and external manufacturing collaborators.
• Establish governance frameworks, stage-gate processes, and best practice models for CMC execution.
• Ensure technical activities meet global regulatory standards, including FDA, EMA, MHRA, and ICH guidelines.
• Provide strategic contributions to regulatory submissions like INDs, IMPDs, BLAs, and Marketing Authorization Applications (MAAs).
• Support business development, due diligence, and portfolio evaluation initiatives as necessary.
• Champion continuous improvement and foster a culture of technical excellence within CMC functions.

Qualifications & Experience

• A degree in Biochemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or related scientific disciplines (Bachelor's, Master's, or PhD).
• Extensive background in CMC, Technical Development, Pharmaceutical Development, Process Development, or Manufacturing Sciences.
• Proven experience in designing CMC strategies specifically for biologics products.
• In-depth understanding of biologics development stages, spanning preclinical and clinical through to commercialization.
• Experience working effectively within multidisciplinary project teams.
• Comprehensive knowledge of international CMC regulatory requirements.
• A demonstrated track record influencing senior leadership and steering strategic initiatives.
• Strong organizational and program management capabilities.

Core Skills & Competencies

• Strategic and scientific thinking.
• Leadership in cross-functional environments.
• Experienced in planning and managing CMC programmes.
• Technical decision-making proficiency.
• Expertise in regulatory strategy formulation.
• Risk assessment and management.
• Engagement with diverse stakeholders.
• Capability in change and operational excellence management.
• Drive for continuous process improvement.