About Akkodis :
Akkodis is a global leader in the engineering and R&D market, leveraging connected data to accelerate innovation and digital transformation. With a team of 50,000 engineers and digital experts, Akkodis provides deep cross-sector expertise across 30 countries in North America, EMEA, and APAC. The company specializes in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI, and data analytics. Its integrated IT and engineering services include Consulting, Solutions, Talents, and Academy, supporting clients in product development, business process improvement, and sustainability initiatives.
Akkodis is part of the Adecco Group. Website: www.akkodis.com
Context :
The Raw Material Scientist is a technical expert responsible for developing and implementing strategies to identify critical raw materials during product development, supporting process decisions. This role involves defining technical controls and ensuring their application in biologics and gene therapy product development to enhance process robustness, cost efficiency, and regulatory readiness.
Key Accountabilities :
* Develop risk assessment strategies for raw materials, identifying critical and key materials from process, quality, and supply perspectives; maintain related databases and dashboards.
* Support Quality by Design (QbD) initiatives by creating documentation guidelines and templates.
* Define mitigations and controls based on risk assessments, collaborating with production, supply, and quality teams.
* Assist in introducing new raw materials, including supplier selection, specifications, and shelf-life definitions.
* Optimize raw material usage in collaboration with process development and manufacturing teams.
* Lead communities of expertise to facilitate knowledge exchange, identify gaps, and develop strategies based on lessons learned.
* Author and review technical documents such as CMC regulatory sections, SOPs, position papers, and reports.
* Gather knowledge from investigations, literature, and industry trends to assess risks and regulatory requirements, proposing alternatives as needed.
* Collaborate with internal and external partners to stay updated on industry developments, risks, and best practices.
* Work across projects and teams within the CMC Development Sciences organization as part of the DSPS team.
Critical Competencies & Experiences Required
Profile :
* Minimum 4 years of experience in CMC development within the biopharmaceutical industry.
* Proven ability to coordinate projects and manage meetings effectively.
* Strong knowledge of bioprocesses (upstream/downstream) with experience in biologics or gene therapy.
* Excellent interpersonal skills to maintain collaborative relationships across departments and with external partners.
* Basic understanding of regulatory guidelines, safety, and quality standards for raw materials.
* Proactive learner with the ability to acquire new knowledge independently.
Why You Can't Turn Down This Offer:
* Mentorship and guidance throughout your role.
* Support for your career development from your Business Manager.
* Active involvement in your training and professional growth.
* Permanent contract with a competitive salary and benefits.
#J-18808-Ljbffr