Chemistry Project Leader Verona

Chemistry Project Leader
Verona
Veneto, Verona

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.

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 R&D 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 package - Support 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 (R&D, 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 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; - 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.