CMC Project Leader within Biologics to Chiesi

Chiesi is now recruiting a CMC Project Leader/Technical Lead 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 extensive industrial experience, a strong technical drug product development background and expert knowledge in CMC for larger molecules/biologics.
Chiesi is an international, researched-focused pharmaceutical company that has established a strong heritage in producing innovative pharmaceutical solutions to improve the quality of human life. The Biotech Research and Product Development 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 focus on meaningful scientific contributions in a collaborative environment.
We will interview candidates continuously and welcome your application today!


RESPONSIBILITIES
As CMC Project Leader you will be a part of the Chemistry Manufacturing and Control (CMC) group in the Biotech Research and Product Development 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 including colleagues in the equivalent CMC-role situated in Stockholm and Parma, Italy.

This is a senior position within Chiesi and you will operate cross CMC function and external stakeholders to guarantee manufacturing and quality of investigational medicinal product and by scouting, selecting, and managing service providers. You will lead the CMC development in projects from early pre-clinical development until late clinical phases. You will also be instrumental in the hand-over of the processes to the commercial manufacturing organization when market authorization has been accomplished.

Main responsibilities include:
- To be responsible for all CMC activities in project Core Teams and to lead Extended Technical Teams.
- To lead the CMC development by planning project activities, keeping track of budget & timelines and interacting with other parts of the project team (pre-clinical, clinical, QA/QC etc.).
- To lead the scouting and selection of new CMOs and CROs from a CMC perspective.
- To manage technology transfers of in-house developed manufacturing processes and related analytical packages to external parties or between external parties.
- To manage the outsourcing activities throughout all clinical development phases both towards internal and external stakeholders.
- To actively participate in regulatory validations both on national and centralized levels i.e. EMA and FDA.
- To achieve proper quality documentation to support clinical trial applications and market authorization applications.
- Involvement in BD Assessments from a CMC perspective.


QUALIFICATIONS
The right candidate has a PhD, MSc or BSc in Chemical/Biochemical Engineering, Biochemistry, Process Science or related field. You have extensive and documented experience from the biopharmaceutical industry with expert knowledge in CMC for larger molecules/biologics. You have CMC experience from several phases of drug development from proof-of-concept to late stage clinical trials.
It is important that you have strong project management skills and are experienced in global cross functional teamwork and in leading and managing internal and external activities, resources and stakeholders. Fluent English both speaking and in writing is required, Swedish knowledge is a plus.
Further experiences sought for:
- Extensive experience in managing outsourcing activities related to manufacturing and characterization of protein therapeutics in clinical development.
- In-depth understanding of the regulatory requirements for development and industry standard for cGMP manufacturing of protein therapeutics.
- Direct experience from regulatory interactions related to CMC preferably with EMA and FDA.

To be successful in this role you have strong interpersonal skills and proven record of effectively participating/leading 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.
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.



ABOUT CHIESI
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.

Poolia Life Science