Business Services & Consulting • all cities, NY 35
Chiesi is an international biopharmaceutical group focused on research, with 90 years of experience and present in over 30 countries, headquartered in Parma, Italy.More than 8,000 collaborators in the group are united by a single objective: to promote a healthier world for people, patients, and the planet.This is what guides us in the research, development, and commercialization of innovative drugs in our main therapeutic areas.Learn more here.At Chiesi, we think about future generations, promoting sustainable and purpose-driven innovation.
This fuels a culture of reliability, transparency, and ethical behavior at all levels.As a Benefit Corporation and certified B Corp, we have integrated sustainability into our charter and constantly measure our impact.Diversity and inclusion are at the heart of our identity.We believe that our differences make us stronger.We are a dynamic ecosystem of passionate and talented people, united by strong values, each one bringing unique perspectives that help us continuously challenge the status quo for the better.
Global Technical Operations & Supply The Chiesi Group has three production facilities: Parma (Italy), the strategic hub for the production and distribution of our products, serving as an international sourcing center with exports to over 80 countries.Solid medicines such as tablets and dry powder inhalers, solutions and suspensions for inhalations, and sterile vials for endotracheal administration are produced here.Blois-La Chaussée Saint Victor (France), a center of excellence specialized in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs).
The site manages direct distribution to customers in the French market and export to other markets, responding effectively to both local and international needs.Santana de Parnaíba (Brazil), specialized in the production of pressurized solutions for inhalation therapy (pMDI).It also has an area dedicated to nasal sprays for the European market.In 2024, the Biotech Center of Excellence was inaugurated in Parma, a new center of excellence for the research, development, and production of biologics.
The Biotech Center of Excellence focuses on biotechnological innovation, with particular attention to the development of monoclonal antibodies, enzymes, and other complex proteins.
Here's what you'll do: The Biotech SME – Sterile DP is the expert in the scientific and technological aspects of the manufacturing process (MS&T) in the production of sterile liquid and lyophilized products at the Parma plant. Its main role is to demonstrate the process's ability to produce a medicinal product that is reproducible and reliable, in accordance with quality requirements and regulatory standards. Its contribution is fundamental within the entire Process Validation cycle, providing technical and scientific support from the process definition phase to the commercial production control phase.
Context – Where you'll work The Parma plant has recently inaugurated the Biotech Center of Excellence, a state-of-the-art production facility to cover the entire production process of biologics from Drug Substance to Drug Product.As a Biotech SME – Sterile DP, you will be involved in activities related to the production process of the finished product, from the formulation of the solution to its packaging.You will join a group of passionate professionals, a multidisciplinary team that works every day to bring innovation, quality, and reliability to sterile production processes.
You will be surrounded by curious, competent, and continuous improvement-oriented people, with whom you can share ideas, grow, and make a real difference.
You will be responsible for: Convalida and process technology Participate in the Performance Qualification activities of the main equipment in the department and in the Process Design of the manufacturing process Define, coordinate, and oversee in-field the activities of Process Performance Qualification Contribute to process control during Continued Process Verification by ensuring statistical control and process performance.Technology transfer Take part in the end-to-end process of technology transfers of sterile products (liquids and lyophilized) at the Parma site, collaborating with R&D, Production, Quality Assurance, Quality Control, and Regulatory Affairs functions.
Technical troubleshooting and continuous improvement Support investigations in case of deviations.Collaborate in the definition and implementation of effective CAPAs.Propose solutions for process improvement and optimization.Risk assessment Draft risk assessment documents (GAP analysis, FMEA).Regulatory support and audit readiness Support as a process SME during regulatory body audits (AIFA, FDA, EMA).Ensure compliance with GMP requirements and international guidelines.
You will need to have: Degree in scientific disciplines (CTF/Pharmacy, Biotechnology, Chemistry, Chemical Engineering, Biology) 3–5 years of experience in the pharmaceutical production field. In-depth knowledge of technologies for sterile liquid and lyophilized products. Quality by Design (QbD) and Quality Risk Management (QRM) approach. Familiarity with equipment/plants and PAT methodologies. Mastery of Lean Six Sigma principles. It would be considered an added value in the selection process if you have worked in international contexts and in the development and/or validation of injectable sterile products.
Soft skills Continuous learning, communication skills, problem solving, planning and organizational skills, teamwork.
Location Parma
What we offer Wherever you start your journey with Chiesi, it will lead to stimulating possibilities.Your future is at the center, and we are committed to supporting your development in a dynamic and friendly environment, with access to resources and training at every stage.We offer top-level benefits, including comprehensive health care programs, work-life balance initiatives, and robust relocation support.The compensation package is competitive and includes base salary, performance bonuses, and market-aligned benefits.
Additionally, we offer work flexibility, remote work options, and tax services for international colleagues, designed to help you thrive.Chiesi is an equal opportunity employer and is committed to hiring a diverse workforce at all levels.All qualified applicants will be considered for employment based on aptitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other legally protected status.
Chiesi is an international biopharmaceutical group focused on research, with 90 years of experience and present in over 30 countries, headquartered in Parma, Italy.More than 8,000 collaborators in the group are united by a single objective: to promote a healthier world for people, patients, and the planet.This is what guides us in the research, development, and commercialization of innovative drugs in our main therapeutic areas.Learn more here.At Chiesi, we think about future generations, promoting sustainable and purpose-driven innovation.
This fuels a culture of reliability, transparency, and ethical behavior at all levels.As a Benefit Corporation and certified B Corp, we have integrated sustainability into our charter and constantly measure our impact.Diversity and inclusion are at the heart of our identity.We believe that our differences make us stronger.We are a dynamic ecosystem of passionate and talented people, united by strong values, each one bringing unique perspectives that help us continuously challenge the status quo for the better.
Global Technical Operations & Supply The Chiesi Group has three production facilities: Parma (Italy), the strategic hub for the production and distribution of our products, serving as an international sourcing center with exports to over 80 countries.Solid medicines such as tablets and dry powder inhalers, solutions and suspensions for inhalations, and sterile vials for endotracheal administration are produced here.Blois-La Chaussée Saint Victor (France), a center of excellence specialized in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs).
The site manages direct distribution to customers in the French market and export to other markets, responding effectively to both local and international needs.Santana de Parnaíba (Brazil), specialized in the production of pressurized solutions for inhalation therapy (pMDI).It also has an area dedicated to nasal sprays for the European market.In 2024, the Biotech Center of Excellence was inaugurated in Parma, a new center of excellence for the research, development, and production of biologics.
The Biotech Center of Excellence focuses on biotechnological innovation, with particular attention to the development of monoclonal antibodies, enzymes, and other complex proteins.
Here's what you'll do: The Biotech SME – Sterile DP is the expert in the scientific and technological aspects of the manufacturing process (MS&T) in the production of sterile liquid and lyophilized products at the Parma plant. Its main role is to demonstrate the process's ability to produce a medicinal product that is reproducible and reliable, in accordance with quality requirements and regulatory standards. Its contribution is fundamental within the entire Process Validation cycle, providing technical and scientific support from the process definition phase to the commercial production control phase.
Context – Where you'll work The Parma plant has recently inaugurated the Biotech Center of Excellence, a state-of-the-art production facility to cover the entire production process of biologics from Drug Substance to Drug Product.As a Biotech SME – Sterile DP, you will be involved in activities related to the production process of the finished product, from the formulation of the solution to its packaging.You will join a group of passionate professionals, a multidisciplinary team that works every day to bring innovation, quality, and reliability to sterile production processes.
You will be surrounded by curious, competent, and continuous improvement-oriented people, with whom you can share ideas, grow, and make a real difference.
You will be responsible for: Convalida and process technology Participate in the Performance Qualification activities of the main equipment in the department and in the Process Design of the manufacturing process Define, coordinate, and oversee in-field the activities of Process Performance Qualification Contribute to process control during Continued Process Verification by ensuring statistical control and process performance.Technology transfer Take part in the end-to-end process of technology transfers of sterile products (liquids and lyophilized) at the Parma site, collaborating with R&D, Production, Quality Assurance, Quality Control, and Regulatory Affairs functions.
Technical troubleshooting and continuous improvement Support investigations in case of deviations.Collaborate in the definition and implementation of effective CAPAs.Propose solutions for process improvement and optimization.Risk assessment Draft risk assessment documents (GAP analysis, FMEA).Regulatory support and audit readiness Support as a process SME during regulatory body audits (AIFA, FDA, EMA).Ensure compliance with GMP requirements and international guidelines.
You will need to have: Degree in scientific disciplines (CTF/Pharmacy, Biotechnology, Chemistry, Chemical Engineering, Biology) 3–5 years of experience in the pharmaceutical production field. In-depth knowledge of technologies for sterile liquid and lyophilized products. Quality by Design (QbD) and Quality Risk Management (QRM) approach. Familiarity with equipment/plants and PAT methodologies. Mastery of Lean Six Sigma principles. It would be considered an added value in the selection process if you have worked in international contexts and in the development and/or validation of injectable sterile products.
Soft skills Continuous learning, communication skills, problem solving, planning and organizational skills, teamwork.
Location Parma
What we offer Wherever you start your journey with Chiesi, it will lead to stimulating possibilities.Your future is at the center, and we are committed to supporting your development in a dynamic and friendly environment, with access to resources and training at every stage.We offer top-level benefits, including comprehensive health care programs, work-life balance initiatives, and robust relocation support.The compensation package is competitive and includes base salary, performance bonuses, and market-aligned benefits.
Additionally, we offer work flexibility, remote work options, and tax services for international colleagues, designed to help you thrive.Chiesi is an equal opportunity employer and is committed to hiring a diverse workforce at all levels.All qualified applicants will be considered for employment based on aptitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other legally protected status.
