descrizione del lavoro

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 LEADERReporting directly to RD Unit Head and working within cross-functional Corporate teams, the candidate will play a key role and actively contribute to the future APIs pipeline.Responsabilities:Identify reliable and competive route of synthesis for the production of new intermediates and API (small molecules) in agreement with the business strategy and IP freedom to operate;Leads and coordinates external RD team through the chemical process definition stages, from route selection, development and optimazation to deliver robust and reliable technical packages ready for industriallization 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 packageSupport internal/external process improvement activities on consolidated APIs;Define and monitor challenging project plans, with progression milestones, KPI’s and related deliverables;Responsible for technology transfer activities from lab to industrial scale;Develop related cost sheets and supports 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 (RD, QA, Regulatory).Key Qualifications / Requirements:Bachelor’s degree in Chemistry, Industrial chemistry, CTF or similar, PhD in relavent fields will be considered a plus;5+ years of RD 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;Italian and English fluent.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;Understands quotations process.Office location: Veneto Region, northern Italy.The position requires a regular presence in the Head Quarters (3 days per week) and is eligible for smart working policy. Some international mobility is required.