Process Development & Drug Substance Manufacturing specialist to Chiesi

Chiesi is now recruiting a Process Development & Drug Substance Manufacturing specialist to their Biotech Unit in Sweden. The position is based at Campus Solna/Stockholm and we are reaching out to find a new colleague with proven industrial experience from drug substance development. The candidate should preferably have a strong technical background within process development 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 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.
As one of our drug substance experts you will play an essential role in drug substance development working closely with our CMC project leaders, Team Leader for Downstream Processing, Senior Scientist Upstream Processing and Senior Analytical Scientist. You will work closely with Contract Development and Manufacturing Organizations (CDMOs) to guarantee manufacturing and quality of drug substance and by scouting, selecting, and managing service providers.
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. Another important part of the role is to contribute to Business Development assessments of new potential projects/products. Preferably you are open to working hands-on in the lab on early development projects as well as to support projects with outsourced manufacturing.

Main responsibilities include:
- To support and actively participate in in-house drug substance development, especially downstream processing activities.
- To lead and be responsible for the drug substance development including planning project activities, keeping track of budget & timelines and interacting with other parts of the CMC extended team and core project team.
- To manage the outsourcing activities throughout all clinical development phases both towards internal and external stakeholders.
- To lead the scouting and selection of new CDMOs for drug substance.
- To manage technology transfers of in-house developed manufacturing processes and related analytical packages to external parties or between external parties.
- Take active part in writing and compiling data for regulatory submissions and in reviewing parts related to drug substance
- Involvement in assessments of new external opportunities and due diligence activities from a drug substance perspective.

Your profile
The right candidate has a PhD, MSc or BSc in relevant scientific discipline. You have experience from the biopharmaceutical industry with expert knowledge in drug substance development for larger molecules/biologics. You have experience from several phases of drug development from proof-of-concept to late stage clinical trials.

Further experiences sought for:
- Experience of hands-on development work in drug substance area.
- Expert knowledge within the field of protein purification.
- Good knowledge in general biochemistry and bioanalytical method development.
- Expert knowledge in scaling-up and transfer of drug substance to large scale GMP production.
- Extensive experience in managing outsourcing activities related to manufacturing of drug substance of protein therapeutics in clinical development.
- In-depth understanding of the regulatory requirements for development and industry standard for cGMP manufacturing of protein therapeutics.
- Experience from regulatory interactions related to Drug substance preferably with EMA/FDA.
- Experience of participation in reviewing CMC documentation during due diligence activities.

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 and you will with ease establish and maintain effective working relationships with internal and external partners. 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.
To thrive at Chiesi you are results driven and enjoy working in a fast-paced environment. You have strong organizational and analytical skills and are able to handle multiple tasks independently and manage priorities in order to meet projects timelines. 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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