Principal Scientist Technical Operations - Drug Product Manufacturing (m/f)

REFERENCE NUMBER:

382250/4

MY DUTIES:

-Provide expertise to support the selection process of drug product CMO
-Lead interaction with CMOs for drug product manufacturing during different phases of product development
-Lead and manage the technology transfer between teams, and external CMOs for phase I, phase II and phase III production
-Evaluate drug product development studies and make recommendations based on their applicability
-Manage externalized manufacturing enabling activities relevant to drug product (mixing studies, filtration studies, extractable/leachable studies)
-Collaborate with process sciences and provide input to ensure transferability to early (phase I, phase II) and late stage manufacturing activities (phase III and BLA)
-Manage external developments in the area of drug product manufacturing in collaboration with process sciences
-Provide documentation and operational input to facilitate IMP management for clinical trials
-Lead process improvement and process characterization of late drug product processes, in collaboration with process sciences
-Define the planning and organization of tech transfer activities with the CMC project leaders
-Interpret and report results of work carried out in written and oral format both internally and externally
-Perform technology watch in the field of drug product manufacturing and monitor innovative technology development

MY QUALIFICATIONS:

-PhD in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 3 years of industrial experience or MSc or equivalent in analytical, pharmaceutical, chemistry, engineering or biochemistry with at least 6 years industrial experience
-Experience in technology transfer and management of drug product manufacturing
-Experience with monoclonal antibodies
-Knowledge of process control methods and process validation
-Strong knowledge of GMP
-Experience in protein formulation and drug product development for both early and late phase development
-Excellent planning and organization skills
-Active and independent problem solving capabilities
-Exposure to the principles of QBD (Quality By Design)
-Experience in team management within a matrix organization
-Highly developed team spirit and ability to work with flexibility and independence in a changing and demanding environment
-Fluency in English, both written and verbal; French is a plus
-Excellent communication skills and strong diplomacy skills required
-Ability to travel abroad several weeks per year

MY BENEFITS:

-Good infrastructure
-Interesting tasks in a multinational environment
-Support throughout the entire application process

ABOUT HAYS:

With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Veronika Walz

Reference number
382250/4

Contact
E-Mail: [email protected]
Phone: +41-(0)44-2255201