Principal Scientist - Synthetic Virus Process Development
- Location: Boston, MA
- Working Situation: In-Person
Our Biotech client is looking for a Principal Scientist to join its CMC team working on oligonucleotide and lipid nanoparticle based synthetic oncolytic viruses. The position of Principal Scientist will serve as the technical and program development leader for out cutting-edge lipid nanoparticle programs. They will collaborate with the CMC Research, and Manufacturing teams to deliver GMP material to the clinical team to support upcoming IND filings. This individual will play a crucial role in assisting them in realizing the full potential of our synthetic oncolytic virus programs.
Key Responsibilities:
- Collaborate with external experts and Research and Process Development Teams to transform their science into effective GMP manufacturing process
- Assist in process definition, CMO selection, facility fit evaluation, and batch production record development
- Design and carry out tests to pinpoint and enhance crucial process parameters and characterize early and late-stage drug product manufacturing processes using risk-based approaches and a thorough understanding of chemistry and engineering principles
- Develop characterization techniques for oligonucleotide and lipid nanoparticles in collaboration with the analytical assay development team
- Create and evaluate batch records, deviations, investigations, and IND sections as well as other GMP and regulatory documentation
Key Qualifications:
- Proven leadership in tech transfer, scaling up processes, and foreign manufacturing
- Understanding of how to operate a bioprocess purification unit for proteins, viruses, DNA, RNA, or other related macromolecules
- Lipid nanoparticle medicinal products and/or oligonucleotide therapies experience desired
- Knowledge of GMPs as they relate to the manufacturing and purification of big biomolecules
Benefits and Perks:
- Health, Dental, Life Insurance
- Unlimited Vacation
- 401K
