Senior Analytical Scientist to Chiesi

Chiesi is now recruiting a Senior Analytical Scientist to their Biotech Unit in Sweden. The position is based at KI Campus Solna/Stockholm and we are reaching out to find a new colleague with industrial experience from drug substance development. The candidate should preferably have a strong technical background within analytics and/or process development for biologics in a R&D setting.

Chiesi is an international, research-focused family-owned 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 international environment.

We will interview candidates continuously and welcome your application today!

About the position
You will be a part of the Chemistry Manufacturing and Control (CMC) group in the Biotech Research and Product Development (BRPD) organization which belongs to the Global Rare Diseases (GRD) Unit. You will report to the Head of CMC, R&D, GRD and will work together with the CMC team, BRPD team and multinational project teams.

Main responsibilities include:
- Analytical method development for biological product CQA’s
- Validation/qualification of analytical methods
- Support inhouse process development with analytical expertise
- Assessment of analytical methods and control strategy for biological products in clinical and commercial phase
- Manage outsourcing of analytical activities
- Manage analytical technology transfers to and between CMO/CROs
- Act as SME in biochemical analysis incl expert review of regulatory documentation
- Setting and justifying release and stability specifications for biological proteins CQAs
- Analyse data from process and product development with a high degree of scientific knowledge

Your profile
The right candidate has a PhD or MSc in relevant scientific discipline. You have experience from the biopharmaceutical industry with expert knowledge in drug substance development for larger molecules/biologics.

Experiences sought for:
- Understanding of the different phases of biopharmaceutical drug development
- Expert knowledge in bioanalytical separation techniques
- Hands on experience of developing analytical methods fit for purpose for purity and/or potency testing
- Good knowledge in protein characterization
- Analytical and quality mindset

Other relevant experiences include:
- Compiling and writing documentations for regulatory submissions
- Acting as subject matter expert in replying to information requests from regulatory authorities
- Working with USP/DSP/DP development
- Working with new “state-of art” analytical techniques

To be successful in this role you have a genuine scientific interest, strong interpersonal skills and proven record of effectively working in multi-disciplinary project teams. You have excellent communication skills and the ability to share your experiences and knowledge in an engaging manner. Further you are analytical, responsible, and thorough and it is important that you are team oriented, social and enjoy working in a global environment. You are meticulous, flexible, and not afraid to help-out in other areas if required. Fluent English both speaking and in writing is required.

About the organisation
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 and for info about the Global Rare Diseases unit, please visit www.chiesiglobalrarediseases.com.

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