Process Development Associate Director
6 giorni 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.ResponsibilitiesLead 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.QualificationsAdvanced degree (Master's or Ph. D.) in Pharmaceutical Sciences, Chemical Engineering, Biotechnology, or related field.Required SkillsLanguages : 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.#J-*****-Ljbffr
-
Process Development Associate Director
4 giorni fa
Lazio, Italia Altro A tempo pienoProcess Development Associate DirectorAt 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...
-
Process Development Associate Director
6 giorni fa
Lazio, Italia Dompé A tempo pienoAbout the RoleThe 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.ResponsibilitiesLead technology transfer activities for drug product from laboratory to pilot / industrial scale...
-
Associate Director M&A
11 ore fa
Lazio, Italia Altro A tempo pienoSeeking an Associate Director M&A to launch and grow a local office.Focus on business development, partnerships, and team building.High commission with partnership potential.
-
Senior Process Development
6 giorni fa
Lazio, Italia Dompé A tempo pienoA 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...
-
Process Development Associate Director
4 giorni fa
Lazio, Italia Altro A tempo pienoLeads technology transfer projects from development to clinical manufacturing, ensuring compliance with GMP and regulatory standards.
-
Emea Regulatory Compliance Lead
6 giorni fa
Lazio, Italia Fitch Ratings A tempo pienoA leading financial services provider is seeking an Associate Director based in Milan.Responsibilities include ensuring compliance with regulatory obligations in EMEA and managing relationships with ESMA.The ideal candidate is highly organized, has excellent drafting and communication skills, and is fluent in English.This position offers a hybrid work model,...
-
Business Development Associate
1 settimana fa
Lazio, Italia Altro A tempo pienoThe Business Development Associate will engage with clients, manage CRM data, and build relationships, requiring fluency in Italian and English.
-
Associate Director, Healthcare
2 giorni fa
Lazio, Italia Apco A tempo pienoThe Associate Director, Healthcare, is a strategic account leader responsible for managing and growing client relationships within the healthcare and pharmaceutical sectors and can work from our office in Rome or Milan.This role focuses on leading integrated scientific and corporate communications activities and multistakeholder and advocacy campaigns...
-
Project Development Director
2 giorni fa
Lazio, Italia Altro A tempo pienoProject Development Director -Fully Remote, ItalyFrom Taylor Hopkinson, we ´re hiring for a fastly growing global IPP.The company develops, finances, builds and operates renewable energy projects across a diverse portfolio, including solar, wind and energy storage solutions, with a strong track record and a growing presence across Europe.In Italy, the...
-
Associate Director
1 settimana fa
Lazio, Italia Apco A tempo pienoAssociate Director needed for regulatory compliance in EMEA, managing compliance and working with regulators in a hybrid work environment.
