Drug Substance Analytical Lead

3 settimane fa

Parma, Italia Chiesi Group A tempo pieno
Who we are looking for Purpose

Support the analytical activities required for producing information and documentation suitable for preclinical and clinical development, and registration of new drug substances, including starting materials and intermediates, with particular focus on risk quality management in accordance with GMP/cGMP

Main Responsibilities

•    Supervise the testing activities on materials for non-clinical and clinical use
•    Study Monitor of analytical method development/validation/transfer studies
•    Study Monitor of stability studies
•    Study Monitor of drug substances characterization studies (e.g. forced degradation studies, solubility profiles, pKa, Log P/D,…)
•    Characterization of materials to support drug substance synthesis and process development studies
•    Critical quality attributes identification and control strategy definition
•    Contribute to select and qualify possible partners through appropriate technical/scientific evaluation
•    CROs/CDMOs management of the outsourced activities
•    Design and integrate analytical development strategy on new drug substances through a scientific risk-based approach to support non-clinical and clinical development
•    Collaborate to define the budget (costs and resources) of the assigned project
•    Promote the technological innovation, scientific understanding and best practices
•    Supervise the activities performed by laboratory technicians including any analytical non-confomity (deviations, OOS, OOT, OOE)
•    Preparation, revision and approval of technical, regulatory and GMP documentation
•    Promote operational excellence (processes/best practices) and continuous quality improvement
•    May contribute to scientific publications and presentations at conferences    
 

Experience Required

5-10 years as Analytical Scientist in manufacturing or pharmaceutical companies (new drug substances development)

Education

Scientific degree in Chemistry or a related field

Languages

Good English

Technical Skills

•    Knowledge of lean six-sigma methodology
•    Knowledge of the solid-state characterization of materials
•    Advanced knowledge of the spectrophotometric, diffractometric, calorimetric, potentiometric, mass spectrometry and chromatographic techniques
•    Advanced knowledge of the univariate statistics
•    Good knowledge of multivariate (PCA, DoE) statistics
•    Good knowledge of the standard informatic tools
•    Advanced documentation editing skills
•    Good knowledge of the business context in the pharmaceutical sector
•    Advanced knowledge of GMP/cGMP and guidelines (ICH, EMEA, FDA) related to the development of new drug substances
•    Advanced knowledge of problem solving, decision making and risk-management techniques

Soft Skills
  • Creative/innovative mindset
  • Decision making
  • Leadership and social influence
  • Goal orientation
  • Learning agility

What we offer

You would join a dynamic, fast-growing, challenging and friendly environment.
In Chiesi we firmly believe that our people are our most valuable asset , that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.
We want our people to come to work happy every day , and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relo

  • Senior DP Analytical Scientist

    1 mese fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose Design, monitor and data elaboration of analytical development studies relevant to inhalation (pMDIs/DPI) and/or biological drug products  Main Responsibilities - Support to CTS release. - Study Monitor of analytical method development studies. - Study Monitor of analytical method...

  • Senior DP Analytical Scientist

    4 settimane fa

    Parma, Italia Chiesi A tempo pieno

    About usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group...

  • Device Lead

    1 mese fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**: Feb 22, 2024 **Department**: GTD Global Technical Development **Job Type**: Direct Employee **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Contract Type**: Permanent **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience,...

  • Etmf and Data Archiving

    1 mese fa

    Parma, Italia Novasyte A tempo pieno

    On behalf of our Client a global pharmaceutical company, IQVIA is looking for a eTMF and Data Archiving who can join an exciting working environment in a dynamic atmosphere. JOB DESCRIPTION: - To ensure data management and statistics trial documentation is managed according to internal standards and regulatory requirements - To oversee activities to ensure...

  • Global Pricing Analyst

    3 settimane fa

    Parma, Italia Chiesi Group A tempo pieno

    Who we are looking for Purpose The Global Pricing Analyst for Care franchise is a highly accountable professional that works cross-functionally with teams across therapeutic areas. His/her main objective is to provide a single point of contact for specific operational pricing/pricing governance matters, as well as to support the development...

  • Sustainability Operations Project Manager

    1 mese fa

    Parma, Italia Davines Italia spa A tempo pieno

    Davines Group is recognized for formulating and manufacturing sustainable high-end hair and skin care products with two specific brands: Davines and [ comfort zone ]. We are a B Corp and our purpose is to do our best for the world, creating good life for all, through beauty, ethics and sustainability. **Sustainability Operations Project Manager**: JOB...

  • Buyer/planner I

    4 settimane fa

    Parma, Italia Thermo Fisher Scientific A tempo pieno

    Here at Thermo Fisher Scientific, our industry-leading scale means unparalleled commercial reach, unique customer access and a global footprint. Our broad customer base, from research, clinical to commercial production means you can have a broad and significant impact. All while working in an environment where you will be supported, valued and rewarded for...

  • Gra Eu Regulatory Affairs Junior Specialist

    4 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**: 30-Mar-2023 **Department**: Global Regulatory Affairs **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Job Type**: Direct Employee **Contract Type**: Permanent **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience,...

  • Equipment Pricing Director

    6 giorni fa

    Parma, Italia Sidel A tempo pieno

    We are looking after a Pricing Director (M/W) for our Capital Equipment Business. You will be responsible for developing and implementing pricing strategies to maximize profitability and market share. You will collaborate closely with cross-functional teams to analyze market dynamics, competitor pricing, and customer value drivers. You will play a critical...

  • Equipment Pricing Director

    6 giorni fa

    Parma, Italia Sidel A tempo pieno

    We are looking after a Pricing Director (M/W) for our Capital Equipment Business. You will be responsible for developing and implementing pricing strategies to maximize profitability and market share. You will collaborate closely with cross-functional teams to analyze market dynamics, competitor pricing, and customer value drivers. You will play a critical...

  • Global Pricing Analyst

    3 settimane fa

    Parma, Italia Chiesi A tempo pieno

    About usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group...

  • Clinical Compliance Specialist

    4 settimane fa

    Parma, Italia Chiesi Farmaceutici A tempo pieno

    **Date**: 30-Mar-2023 **Department**: Global Clinical Development **Team**: R&D, Pharmacovigilance & Regulatory Affairs **Job Type**: Direct Employee **Contract Type**: Temporary **Location**: Parma, IT About us Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience,...

  • Equipment Pricing Director

    2 giorni fa

    Parma, Italia Sidel A tempo pieno

    We are looking after a Pricing Director (M/W) for our Capital Equipment Business. You will be responsible for developing and implementing pricing strategies to maximize profitability and market share. You will collaborate closely with cross-functional teams to analyze market dynamics, competitor pricing, and customer value drivers. You will play a critical...

  • Equipment Pricing Director

    7 giorni fa

    Parma, Italia Sidel A tempo pieno

    We are looking after a Pricing Director (M/W) for our Capital Equipment Business. You will be responsible for developing and implementing pricing strategies to maximize profitability and market share. You will collaborate closely with cross-functional teams to analyze market dynamics, competitor pricing, and customer value drivers. You will play a critical...

  • Equipment Pricing Director

    7 giorni fa

    Parma, Italia Sidel A tempo pieno

    Equipment Pricing Director (M/W) Contract Type Permanent Country ITALY Location Parma Your opportunity We are looking after a Pricing Director (M/W) for our Capital Equipment Business. You will be responsible for developing and implementing pricing strategies to maximize profitability and market share. You...

  • Trainee Area Manager

    1 mese fa

    Parma, Italia Amazon A tempo pieno

    ****Please note that this position could be based in any Amazon Operations center across Emilia - Romagna Region, depending on availability and business needs. Relocation support will be provided as needed.****Would you like to work as part of an innovative, fast-paced, and motivated team?Are you up for creating solutions and solving tomorrow’s operational...

  • Supply Chain Internship

    3 giorni fa

    Parma, Italia Barilla Group A tempo pieno

    Barilla Worldwide Barilla is an Italian family-owned food company. Our story begins in Parma in 1877, and today, we are an International Group present in more than 100 countries. Thanks to our 29 production facilities and more than 8,700 employees, each year we provide over 2,109,000 tonnes of products to people, being the world leader in the markets...