Process development associate director
2 settimane fa
About the Role
The Process Development Associate Director leads technology transfer projects from development to clinical manufacturing, ensuring compliance with GMP and regulatory standards while driving operational excellence and timely delivery.
Responsibilities
Lead technology transfer activities for drug product from laboratory to pilot / industrial scale for clinical production.
Support late-phase development and transfer of new product / processes to commercial manufacturing sites.
Ensure compliance with GMP, ICH guidelines, and global regulatory requirements throughout the transfer process.
Support manager in develop and implement transfer strategies, including timelines, resource planning, and risk mitigation plans.
Coordinate cross-functional teams (R& D, Manufacturing, Quality Assurance, Regulatory Affairs) to guarantee seamless execution.
Identify and activate new CDMO for clinical batch production.
Oversee scale-up and process validation (where required) ensuring robust and reproducible manufacturing processes.
Manage technical documentation, including protocols, reports, and knowledge transfer packages.
Act as primary liaison between internal stakeholders and external partners / CDMOs for project alignment and issue resolution.
Support CMC team in preparing documentation for IND, BLA, or NDA submissions.
Drive continuous improvement initiatives to optimize tech transfer processes and reduce operational risks.
Support global supply chain objectives, ensuring timely delivery and cost efficiency.
Qualifications
Advanced degree (Master's or Ph. D.) in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.
Required Skills
Languages : Italian & English (fluent);
Knowledge of the main productivity and collaboration tools (Google Workspace, MS Office);
Strong knowledge of GMP, ICH guidelines, and global regulatory requirements.
Expertise in process development, scale-up, and validation for drug substance and drug product.
Familiarity with aseptic processing, biologics manufacturing, and analytical methods.
Proficiency in project management tools and risk assessment methodologies.
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