Scientist, Drug Product Operations and Pilot Plant
Posted 06 Oct 2023
Guidonia Montecelio, Rome - Italy
Req Id 268763
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:
As Scientist, you are expected to develop robust processes for parenteral formulations for NBEs and Biosimilars within the Global Parenterals Development Group including scale-up, process characterization and tech transfer to commercial manufacturing sites. 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 scale 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 Global Parenterals Development Group, evaluate data, write study protocols 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 Healthcare Operations 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, foster strong team spirit and promote knowledge exchange within and between teams.
Who you are:
- Degree in Engineering, 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. Experience with techniques aimed at determining optimal freeze-drying conditions (e.g, Freeze-drying microscope, Differential scanning calorimetry)
- Familiarity with formulation and process development of parenteral dosage forms
- 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) 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
- Good communication skills and proven problem solving ability
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!