Chemistry Project Leader Ne

Chemistry Project Leader
Ne
Liguria, Ne

Our client is a global CDMO player , facing a strong growth into the development and production of APIs and advanced intermediates for custom and generic manufacturing. It has a long history of innovation in the pharmaceutical sector and is recognized worldwide for its high level specialization, competencies and strong know-how, which allowed it to become the partner of the most important pharmaceutical companies worldwide. To enable the Group's continuous growth and mission, we are currently looking for the: CHEMISTRY PROJECT LEADER Reporting directly to R&D Unit Head and working within cross-functional Corporate teams, the candidate will play a key role and actively contribute to the future APIs pipeline. Responsibilities: Identify reliable and competitive route of synthesis for the production of new intermediates and API (small molecules) in agreement with the business strategy and IP freedom to operate; Lead and coordinate external R&D team through the chemical process definition stages, from route selection, development and optimization to deliver robust and reliable technical packages ready for industrialization and process validation; Work in coordination and alignment with Analytical project leader for the co-development of associated analytical methods for raw materials, intermediates, potential genotox or nitrosamine impurities and the final API as an integrated part of the final technical package; Support internal/external process improvement activities on consolidated APIs; Define and monitor challenging project plans, with progression milestones, KPIs and related deliverables; Responsible for technology transfer activities from lab to industrial scale; Develop related cost sheets and support the Portfolio manager in creating business cases for both new and consolidated generics; Provide details for preparing RFP to be submitted to external contractors or to internal units; Coordinate responses to Deficiency Letters and related requests for technical support from business functions (R&D, QA, Regulatory). Key Qualifications / Requirements: Bachelor's degree in Chemistry, Industrial chemistry, CTF or similar; PhD in relevant fields will be considered a plus; 5 years of R&D experience as organic chemist and chemical lead in the development of API in well-established CDMO; Demonstrated successful experience with scale-up and optimization of lab procedures up to commercial scale under GMP conditions, including knowledge and application of Pharmaceutical Quality by Design (QbD) principles; Excellent knowledge of GMP, and ICH guidelines related to commercial Drug Substance manufacturing; Good knowledge of Microsoft Office; MS Project is a plus; Good knowledge of Project Management practices; Fluency in Italian and English. Soft Skills: Well organized and detail oriented; Ability to prioritize multiple tasks; Problem solving, decision making, negotiation and influencing capacity; Strong ability to establish meaningful connections: attentive listening, impactful message delivery, understanding, proactive approach; Location: Veneto Region, northern Italy. The position requires a regular presence in the Headquarters (3 days per week) and is eligible for a smart working policy. Some international mobility is required. Seniority level Mid-Senior level Employment type Full-time Job function Research Industries Pharmaceutical Manufacturing, Chemical Manufacturing, and Biotechnology Research J-18808-Ljbffr