Process development associate director

Dompé; Roma; In loco; EUR 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company in Italy is looking for a Process Development Associate Director to oversee technology transfer projects from development to clinical manufacturing. This role requires expertise in regulatory compliance, project management, and cross-functional team coordination. Candidates should possess an advanced degree in a relevant field and be fluent in both Italian and English. The position offers a chance to drive operational excellence and improve tech transfer processes.

Competenze

• An advanced degree in a relevant field is required.
• Fluency in both Italian and English is essential.
• Strong knowledge of GMP and regulatory requirements is crucial.

Mansioni

• Lead technology transfer activities for drug product from lab to pilot scale.
• Support late-phase development and transfer of new products to commercial sites.
• Ensure compliance with regulatory requirements during transfer.

Conoscenze

Fluent in Italian

Fluent in English

Knowledge of productivity and collaboration tools

Strong knowledge of GMP

Expertise in process development

Familiarity with aseptic processing

Proficiency in project management tools

Formazione

Master's or Ph.D. in Pharmaceutical Sciences, Chemical Engineering, Biotechnology

Strumenti

Google Workspace

MS Office

Descrizione del lavoro

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.