Senior Analytical Scientist within biologics to Chiesi

Are you an expert in HPLC and method development of chromatographic methods? Do you have experience from working with larger molecules/biologics?
Chiesi is now recruiting a senior Scientist within analytical development to their Biotech Unit in Sweden, based at Campus Solna/Stockholm. We are reaching out to find a new colleague with proven industrial experience from developing and performing analytical methods for biologics in a R&D setting meeting GxP requirements.
Chiesi is an international, research-focused pharmaceutical company that has established a strong heritage in developing innovative pharmaceutical solutions to improve the life of patients with high unmet medical needs. The Biotech Research and Product Development (BRPD) unit in Sweden is a crucial part of Chiesi´s strategy for bringing new innovative medicines to the patients. This is an excellent opportunity for you to join a great team with an exciting biopharmaceutical product pipeline and to focus on meaningful scientific contributions in a collaborative environment.

We would be happy to receive your application as soon as possible. From January interviews and presentation of candidates will take place on an ongoing basis.

RESPONSIBILITIES

You will be a part of the Chemistry Manufacturing and Control (CMC) group in the BRPD organization which belongs to Chiesi’s Global Rare Disease Unit.
You will be employed at Chiesi and be part of an organization working on developing biological drugs. The pipeline includes product in all development phases including marketed products. You will play an essential role in leading analytical activities for biologics like method development, qualifications, method transfer, and analysis. In addition, you will be engaged in regulatory activities such as compiling data for submissions and being part of internal response teams to regulatory questions.

Your main responsibilities will include:
- Development of analytical methods to characterize Drug Substance and Drug Product
- Characterization of Drug Substance and Drug Product stand-alone or in collaboration with relevant CRO or collaboration partner
- Data analysis and interpretation
- Responsible for the technology transfer of analytical methods to CRO and CMO
- Prepare written documentation of the final analytical methods as well as analytical development reports
- To assure that methods are developed to meet the project timelines and requirements
- Take active part in writing and compiling data for regulatory submissions and in reviewing as related to analytical development and characterization



QUALIFICATIONS
The right candidate has preferably a PhD or a MSc or BSc in relevant scientific discipline and a minimum of at least five years of experience from the pharmaceutical industry working with analytical development and characterization of biological drugs.
You have expert knowledge within the field of protein analysis and characterization and solid practical experience of chromatographic methods with HPLC or UPLC such as SEC, RP, HIC and IEC. You also have experience of development in the methods mentioned and experience of transfer of methods to QC lab. Fluent in English, both speaking and in writing is required. If you speak Swedish it is an advantage.

Further desirable experiences:
- Knowledge of GMP compliance
- Experience form regulatory activities related to analytical methods development and characterization

To be successful in this role you have a genuine scientific interest. Further you are analytical, responsible and thorough and it is important that you are team oriented, social and enjoy working in a global environment. Further you are meticulous, flexible, and not afraid to help-out in other areas if required. You enjoy working hands-on in the laboratory but also to support out-sourced activities and collaborations.




ABOUT CHIESI PHARMA
A GLOBAL FAMILY DEDICATED TO PEOPLE AND PATIENTS
In Chiesi our approach as a Benefit Corporation is a way of being as well as a way of thinking. We redefine the way to do our business, to create a positive impact on people, environment and our global Chiesi Community, acting as a force for good.
We are passionate and committed to improving and raising the quality of human life and making meaningful contributions that will have a positive long lasting impact. Our entrepreneurial thinking, our sustainable and innovative ideas, transformative solutions and our personal chemistry are the key elements that bonds us and make us grow as one cohesive global Chiesi family.
EVERYONE OF US IS DIFFERENT, EVERYONE OF US IS CHIESI
For information about Chiesi, please visit www.chiesi.com



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