Requirements: English
Company: Nouscom
Region: Province of Latina , Lazio
Nouscom is a private clinical stage immuno-oncologycompany developing next-generation, off-the-shelf and personalizedcancer vaccines. Our proprietary viral vector platform has thecapacity to encode for large payloads of neoantigens or otherimmunomodulators and is clinically demonstrated to safely andpotently harness the power of the immune system. We are seeking aDocumentation Assistant with experience in the preparation of CMCdocuments in the field of Advanced Therapy Medicinal Products(ATMP). The successful candidate will support the drafting of CMCregulatory documentation according to EU and US regulations. Inaddition, She/he will assist the oversight of ATMP manufacturingprocesses including analytical control and release of material thatwill be tested in clinical trial. Finally, she/he will collaboratewith interdisciplinary teams to facilitate the development andcommercialization of viral vector-based products. Keyresponsibilities: - CMC Regulatory Documentation: Support thepreparation and compilation of CMC regulatory dossiers (IMPD, IND,BB) in accordance with EU and US regulatory requirements. Ensurethat all documents are accurate, complete, and finalized accordingto clinical trial schedule. - Viral Vector Manufacturing Oversight:Assist in overseeing the manufacturing processes of viral vectors,ensuring that the production is compliant with relevant EU and USregulations. Monitor and support the analytical control ofmaterials intended for clinical trials, ensuring quality andconsistency. - Collaboration with Interdisciplinary Teams: Workclosely with cross-functional teams (e.g., R&D, RegulatoryAffairs, Quality Assurance, and Manufacturing) to ensure seamlesscommunication and alignment on development timelines, regulatoryrequirements, and product development. Participate in projectmeetings, providing input on CMC-related matters to facilitate thedevelopment and commercialization of viral vector-based products. -Clinical Trial Material Release: Assist in the release of materialsfor clinical trials, ensuring that all required testing areperformed and that the materials meet regulatory and qualitystandards. - Regulatory Compliance: Ensure that all documentationand processes comply with applicable regulatory guidelines (EU andUS), including current Good Manufacturing Practices (cGMP). Trackand implement updates to regulations, ensuring compliancethroughout the product lifecycle. - Risk Management andDocumentation Control: Support risk management activities,particularly in relation to the manufacturing and release ofmaterials, and regulatory requirements. Ensure that properdocumentation control procedures are in place and adhered to,including the creation, review, and maintenance of standardoperating procedures (SOPs), batch records, and regulatorysubmission documents. Job requirements: Education: - A degree inscientific disciplines (Biotechnology, Chemistry, Biology,Pharmacy, or similar fields) Professional Experience: - Basicexperience (2-3 years) in similar roles within the pharmaceuticalor biotech industry, preferably with a focus on viral vectorsCompetencies & Personal Skills: - General knowledge of GMPregulations and regulatory requirements related to CMCdocumentation - Familiarity with risk analysis principles,preferably applied in the pharmaceutical/biotech context - Strongorganizational and problem-solving skills, with a proactiveattitude and eagerness to learn - Good command of English, bothwritten and spoken Offer: This position provides the opportunity tocontribute to the development of advanced therapies in a dynamicand innovative environment, with opportunities for professionalgrowth and continuous training. As part of a small high growthbusiness you will get the opportunity to be involved in manydifferent areas and our rapid growth trajectory means you will havethe opportunity to grow with us. Nouscom is an equal opportunityemployer. We welcome applications from all individuals. We arecommitted to treating all applicants fairly and avoidingdiscrimination.