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 levelMid-Senior levelEmployment typeFull-timeJob functionResearchIndustriesPharmaceutical Manufacturing, Chemical Manufacturing, and Biotechnology Research

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