Requirements: English
Company: Nouscom
Region: Rome , Lazio
Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. Our proprietary viral vector platform has the capacity to encode for large payloads of neoantigens or other immunomodulators and is clinically demonstrated to safely and potently harness the power of the immune system.
We are seeking a Documentation Assistant with experience in the preparation of CMC documents in the field of Advanced Therapy Medicinal Products (ATMP).
The successful candidate will support the drafting of CMC regulatory documentation according to EU and US regulations. In addition, She/he will assist the oversight of ATMP manufacturing processes including analytical control and release of material that will be tested in clinical trial. Finally, she/he will collaborate with interdisciplinary teams to facilitate the development and commercialization of viral vector-based products.
Key responsibilities:
- CMC Regulatory Documentation: Support the preparation and compilation of CMC regulatory dossiers (IMPD, IND, BB) in accordance with EU and US regulatory requirements. Ensure that all documents are accurate, complete, and finalized according to 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 US regulations. Monitor and support the analytical control of materials intended for clinical trials, ensuring quality and consistency.
- Collaboration with Interdisciplinary Teams: Work closely with cross-functional teams (e.g., RD, Regulatory Affairs, Quality Assurance, and Manufacturing) to ensure seamless communication and alignment on development timelines, regulatory requirements, and product development. Participate in project meetings, providing input on CMC-related matters to facilitate the development and commercialization of viral vector-based products.
- Clinical Trial Material Release: Assist in the release of materials for clinical trials, ensuring that all required testing are performed and that the materials meet regulatory and quality standards.
- Regulatory Compliance: Ensure that all documentation and processes comply with applicable regulatory guidelines (EU and US), including current Good Manufacturing Practices (cGMP). Track and implement updates to regulations, ensuring compliance throughout the product lifecycle.
- Risk Management and Documentation Control: Support risk management activities, particularly in relation to the manufacturing and release of materials, and regulatory requirements. Ensure that proper documentation control procedures are in place and adhered to, including the creation, review, and maintenance of standard operating procedures (SOPs), batch records, and regulatory submission documents.
Job requirements:
Education:
- A degree in scientific disciplines (Biotechnology, Chemistry, Biology, Pharmacy, or similar fields)
Professional Experience:
- Basic experience (2-3 years) in similar roles within the pharmaceutical or biotech industry, preferably with a focus on viral vectors
Competencies Personal Skills:
- General knowledge of GMP regulations and regulatory requirements related to CMC documentation
- Familiarity with risk analysis principles, preferably applied in the pharmaceutical/biotech context
- Strong organizational and problem-solving skills, with a proactive attitude and eagerness to learn
- Good command of English, both written and spoken
Offer:
This position provides the opportunity to contribute to the development of advanced therapies in a dynamic and innovative environment, with opportunities for professional growth and continuous training.
As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us.
Nouscom is an equal opportunity employer. We welcome applications from all individuals. We are committed to treating all applicants fairly and avoiding discrimination.