About Akkodis :
Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines – Consulting, Solutions, Talents and Academy – to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.
Akkodis is part of the Adecco Group. Our Webstite : www.akkodis.com
Context :
The Raw Material Scientist is a technical expert responsible for establishing and coordinating a comprehensive strategy to identify critical/key raw materials during development to support process development decision making. He/She will support the definition of appropriate technical controls and the implementation these practices during the development of biologics and gene therapy products to improve process robustness, cost efficiency, and readiness for regulatory submissions.
Key Accountabilities :
Generate risk assessments strategy for current raw materials and identify critical and key ones from a process, quality and supply point of view. Create and maintain related database and dashboard.
Support the QbD initiative on raw material by writing supportive documentation (generate guidelines and templates)
Define based on risk assessment mitigations and controls to be implemented in collaboration with appropriate teams (in production, release at supplier, shipment, storage, during usage).
Support the introduction of new raw materials in close collaboration with process teams (supplier selection criteria at early stage, IPC/specifications definitions, shelf life definitions, ..)
Improve raw materials usage in collaboration with process development and clinical manufacturing
Create and lead satellite communities per expertise to facilitate exchanges, identify gaps and mitigations, build strategies on lessons learnt and successes to prepare future.
Author & review technical documents including CMC regulatory sections, SOPs, technical position papers, & technical reports
Accumulate knowledge based on lessons learnt, investigation and literature on potential risks, quality and regulatory requirements and suggest alternatives
Collaborates with internal and external partners to stay abreast of industry trends and emerging risks related to raw materials, regulatory and quality requirements evolution, best practices.
As a member of the DSPS team, the raw material scientist may work transversally across projects and groups in line with the needs of the business and as part of the CMC Development Sciences organization.
Critical Competencies & Experiences Required
Profile :
> 4 years of experience in CMC development within the biopharmaceutical industry.
Demonstrated ability to successfully co-ordinate project activities and manage meetings.
Good knowledge of bioprocesses (Upstream/Downstream) with previous technical experience in Biologics or Gene therapy.
Good interpersonal skills in order to communicate with and maintain fruitful working relationships with colleagues across departments and geographies, as well as external partners.
Basic knowledge of regulatory guidelines, safety and quality requirements for raw materials
Ability to learn proactively by him/herself
Why You Can't Turn Down This Offer:
As a member of the AKKODIS team, you will:
* Be guided in your role through a mentoring process
* Receive support for your career from your Business Manager
* Play a key role in your training plan and personal and professional development
* Benefit from a permanent contract
* Enjoy a competitive salary package that includes various additional benefits