Chemistry Project Leader

4 settimane fa

Provincia di Verona, Italia Gruppo Proper Transearch A tempo pieno

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 fortechnology transfer activities from lab to industrial scale;
  • Develop relatedcost sheets and supports the Portfolio manager in creating business cases for both new and consolidated generics;
  • Provide detailsfor 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&Dexperience 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.

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