Senior/ Principal Scientist, LNP Analytics

CRISPR Therapeutics•South Boston, MA

15d•$147,000 - $185,000•Onsite

About The Position

Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. Position Summary We are seeking a highly motivated Senior Scientist/Principal Scientist to join our Analytical Development team focused on LNP delivered in vivo therapeutics. This individual will be a key contributor to method development for LNP and related modalities, working both hands-on in the lab and in collaboration with contract labs (CROs). The successful candidate will bring a deep understanding of analytical methods, regulatory requirements, and a passion for innovation and problem-solving in a fast-paced environment.

Requirements

PhD in Biochemistry, Molecular Biology, Analytical Chemistry, or related discipline with Senior Scientist: 5+ years of relevant industry experience, or non-PhD and 12+ years progressive, relevant experience.
Proven expertise in developing, troubleshooting, and executing assays for LNP or related products.
Strong understanding of in vivo gene therapy delivery platforms.
Advanced analytical and data analysis skills.
Experience working with external laboratories (CMOs/CROs) for method development and stage-appropriate validations.
Understanding of regulatory and compendial expectations (e.g., ICH, USP/Eur.Ph.) for mRNA and for analytical methods.
Excellent written and verbal communication skills.
Ability to work independently and collaboratively in a dynamic, matrixed environment.
Scientific curiosity and creativity.

Nice To Haves

Prior experience with analytical support for regulatory filings (e.g., IND, IMPD, BLA).
Familiarity with platform analytical approaches for mRNA therapeutics and LNP-formulated Cell and Gene Therapy products.
Experience with liquid handler platforms and method automation.
Demonstrated ability to lead cross-functional initiatives or technical teams.
Passion for science, high level of integrity, and a proactive mindset aligned with core values of collaboration, undaunted spirit, resilience, and entrepreneurship.

Responsibilities

Hands-on development, execution and troubleshooting of analytical assays to characterize and quantify LNPs and related materials.
Design, perform, and provide guidance for method development, optimization, troubleshooting, feasibility, transfer, qualification of analytical methods for internal and external stakeholders.
Spearhead the evaluation and adoption of new technologies and new analytical methods.
Serve as a technical lead and subject matter expert (SME) for analytical projects at CMOs/CROs ensuring scientific rigor and regulatory compliance.
Provide analytical expertise for comparability studies to support manufacturing process changes and product lifecycle management.
Author and review SOPs, analytical protocols, technical reports, and regulatory submission documents (e.g., IND, BLA).
Apply a range of biochemical and biophysical analytical techniques including FFF-MALS, nFCM, NTA, CE, Chromatography, Mass Photometry, etc. relevant to LNP DS and DP.
Interpret and present complex analytical data with clarity to internal stakeholders and regulatory agencies.
Mentor and/or supervise junior scientists, providing guidance on experimental design, troubleshooting, and career development.
Collaborate cross-functionally with Research, Process Development, Quality, and Regulatory teams to support program advancement from early development and preclinical through clinical and commercial stages.
Foster a culture of resilience, collaboration, and entrepreneurial thinking.