Physico-Chemical Methods Unit Head

Posted 11 Oct 2023

Guidonia Montecelio, Rome - Italy

Req Id 268837

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 


 

Your role:  

 

An exciting new opportunity has arisen at our State-Of-The-Art Biotech Development Facility in Guidonia, company's reference site for the development of new chemical entities (NCEs) and new biological entities (NBEs) including analytical, pharmaceutical development and centralized QC&Stability. Reporting to the “Head of Analytical Development & Innovation NBEs” in the Global Analytical Development organization, this role represents an opportunity to significantly contribute to E2E CMC development of company's biotech programs as Analytical Methods Development and Validation, Tech Transfer and LCM leader of a team of scientists devoted to advanced innovative Analytics such as QbD approaches and state of the art techniques. You will provide strong scientific leadership in analytical development and validation of physico-chemical methods (Chromatographic, Electrophoretic, Spectrophotometric, and Generic Compendial) through the overall lifecycle of biotech products, from early phases up to market and post-market with main focus on late stages and PAC; you will be responsible with his/her/their team for the successful and timely delivery of submission analytical work packages to support non GMP and GMP testing of Biologics DS, DP and IPCs for development, clinical and commercial scopes; you will nsure application of appropriate GxP standards in the team as defined in Quality Manuals, GMP procedural landscape, EHS and ethical guidelines assuming influential role; you will act as main interface for inspections with HAs and partners on areas of PCM Unit Accountability; you will drive scouting and implementation of innovative analytical approaches through QbD and with focus on digital systems and high throughput analyses, automation and ready-to-use in QC environment for late stage development; you will be responsible of budget and resource forecast, ensuring cost awareness and tracking for his/her/their Unit; you will recommend and drive improvements to existing systems, processes, techniques, or programs to reach operational efficiency and cost effectiveness; maintain and foster strong and positive relationship with the other teams of the Company network, especially within QC network and Regulatory, with HAs and collaborate with other experts in the context of Scientific Community of Practices, keeping up-to date knowledge of literature and technology associated with the field of expertise; manage effectively outer stakeholders i.e. company group and external Partners; manage team by behavioral leadership built on company's behavioral model, fostering team member’s development , empowerment and engagement, leading and mentoring lab managers, scientists and compliance specialists. 

 

  

Who you are:  

 

  • Graduate degree in Chemistry, Pharmacy, Biology, Biotechnology or related field - ideally a PhD or equivalent experience in analytical development.  
  • Deep analytical background (+10 yrs experience) and bold leadership in biotech industry, with not less than 5 yrs in managerial positions.  
  • Knowledge of process and product critical quality attributes 
  • Strong GMP know-how and regulated environments management experience, including audits and HAs inspection readiness
  • Knowledge of international guidelines (e.g. ICH) and main Pharmacopeias and good understanding of regulatory expectations for biopharmaceuticals; knowledge of Data generation, data processing, data Quality principles, Quality by Design (e.g., DoE)
  • Preferred previous hands-on experience with laboratory information systems, digital tools and lean principles
  • Proven leadership and managerial experience of analytical development&validation and/or QC teams in biotech company
  • Resilient to work under pressure and in matrix environments with great networking skills and proven ability to negotiate effectively with internal stakeholders and external organizations, including conflicts management
  • Excellent communication, problem-solving, organizational skills, highly motivated, people oriented and collaborative mindset
  • A true people developer, empowering the Team and growing in your own role as competitive advantages for the organization
  • English fluent

 



What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

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