Process Development Associate Director

5 giorni fa

L'Aquila, Abruzzo, Italia Dompé A tempo pieno

At Dompé Farmaceutici, we are not just a pharmaceutical company, we are an innovation-driven organization with over 130 years of experience, committed to advancing science and improving human health.

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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