Senior Principal Scientist - Remote
Core
Senior scientific subject matter expert for Chemistry, Manufacturing and Controls (CMC) activities supporting innovative biologics, including cell and gene therapy.
Role type
Senior Principal Scientist (CMC)
Builds
Innovative biologics programs across development, technical operations, quality, regulatory, and supply chain.
Domain
Biotechnology / Cell and Gene Therapy / CMC
Required skills
CMC strategy, process development, analytical development, characterization, manufacturing, technology transfer, stability, control strategy, lifecycle management, risk-based recommendations, cross-functional collaboration, external partner management (CDMOs/CROs), mentoring, best-practice framework deployment.
Preferred skills
Cell and gene therapy expertise, AAV or viral vector development, baculovirus-based expression systems, insect cell platforms, oligonucleotides, nucleic acid-based therapeutics, recombinant proteins, global matrix organization experience.
Technologies
AAV, viral vectors, baculovirus, insect cell platforms, oligonucleotides
Responsibilities
Provide expert technical assessment and scientific guidance to program teams; develop data-driven technical recommendations balancing scientific rationale and regulatory expectations; serve as subject matter expert for cell and gene therapy platforms; provide oversight for work with external development and manufacturing partners; participate in cross-functional program teams; strengthen organizational capability by sharing platform knowledge and mentoring colleagues.
Seniority
Principal, hands-on IC with strategic influence