Raw material scientist
Role Summary
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.
They 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 and supply point of view.
- Support the QbD initiative on raw material and GRAM exercise (CMA KMA definition, generate guideline 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 design supportive studies required.
- 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
- At the very least 2 years of experience in CMC development within the biopharmaceutical industry.
- Demonstrated ability to successfully co-ordinate project activities and manage meetings.
- 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.
Our offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
