Principal Scientist, Formulation Development
A truly global player in the discovery of new molecules are looking to expand their team by recruiting a Principal Scientist, Formulation Development. The company prides itself on its significant presence in the branded generics market across emerging economics, including parts of Asia. This role will be based at their site in Switzerland, offering an exciting opportunity to work with an international team of over 9,000 employees based in over 80 countries.
- Conceptualize and lead early and late stage formulation development (liquid, lyophilized, high concentration etc.) for the company's NBE and Biosimilar products.
- Develop and optimize processes (UFDF concentration, lyophilization) for the company's NBE and Biosimilar products.
- Manage activities relevant to drug product development (mixing studies, filtration studies, extractable/leachable studies etc.) for the company's NBE and Biosimilar products.
- Responsible for technology transfer from the Formulation Development group to Technical Operations team in the company or to external CROs/CMOs during different phases of product development.
- Manage Formulation Development team including overseeing professional development, education, coaching and training, with continuous focus on improving working processes.
- Manage long-term stability studies. Oversee day-to-day laboratory management.
- Actively contribute to relevant part of section 3 of IND/IMPD's.
- Interpret and report results of work carried out in written and verbal format both internally and externally.
- Evaluate external developments in the area of formulation development and make recommendations based on their applicability for the company's projects.
Skills and Requirements:
- PhD in analytical, pharmaceutical, chemistry, engineering, or biochemistry with at least 3 years of industrial experience; MSc or equivalent in analytical, pharmaceutical, chemistry, engineering, or biochemistry with at least 6 years industrial experience.
- Significant experience in protein/monoclonal antibodies/bispecific formulation for both early and late phase development.
- Experience in process development related to drug products (lyophilization, high concentration) manufacturing.
- Knowledge of technology transfer and regulatory submissions in USA/EU for sections relevant to drug product development/manufacturing.
- Exposure to the principles of QBD (Quality By Design) and DOE (Design of Experiment).
- Fluency in English, both written and verbal; French is a plus.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Chidozie Orji at +44 207 440 0671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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