Scientist, Drug Product process development

Posté 22 juil. 2022

Guidonia Montecelio, Rome - Italy

Demander un identifiant 253040

Détails

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 

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


As a Scientist you are expected to lead Process Development activities for NBEs and Biosimilars within the Pharmaceutical Development Group. Must have technical skills for this position include theoretical knowledge and hands-on experience with Lyophilization operations at laboratory scale (development of lyophilization cycles), with following scale up to pilot as well as support to manufacturing sites for full scale manufacturing. With minimal supervision from Manager, you will design experiments to support program strategy, coordinate execution of activities carried out by personnel within the Pharmaceutical Development Group, evaluate data, write study protocol and reports in support of technical programs as they progress from early development into clinical phases. You will take on an active role as reference, expert person for your assigned area of responsibility, you will participate to core project meetings and work closely with colleagues from the Global Development and Launch network (Manufacturing, Regulatory, Quality Control, Analytical Development, CMC Teams) in order to support technical transfers and process validation activities for drug product. You will comply with quality standards and health and safety procedures, support innovation and improvement initiatives within the Department.

 

 

Who you are

 

  • Degree in Chemistry, Biotechnology or Biology, CTF. PhD and/or specializations like Masters in Pharmaceutical Development highly desired
  • Minimum 5 – year experience in Drug Product Development of biopharmaceutical products (research and/or industrial environment)
  • Sound knowledge and hands-on experience in manufacturing techniques of biologics with focus on lyophilization operations and relevant support to manufacturing sites, even in the frame of investigations
  • Good theoretical and practical knowledge on techniques aimed at the characterization of physico-chemical state of proteins (e.g Chromatography, SDS-Page, Capillary Isoelectrofocusing Electrophoresis, particles counting by light obscuration or MFI). Additional theoretical and practical knowledge of protein higher order structure analysis (by mean of orthogonal techniques including circular dichroism (CD), infrared spectroscopy (FT-IR), fluorescence spectroscopy, DSC) and of techniques for fluidic characterization of solutions (rheology, density)
  • Project management experience is a plus
  • Good knowledge of spoken and written English
  • Good knowledge of statistics and statistical tools and proficiency in Office tools

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. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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