Principal Scientist, Bioanalytical

Epicrispr Biotechnologies•South San Francisco, CA

20h•Onsite

About The Position

Epicrispr Biotechnologies is based on the science of its founder, Stanley Qi, one of the original CRISPR co-inventors, who furthered the technology to regulate the epigenome to suppress and activate multiple genes simultaneously without cutting DNA. The company is evolving this platform to address unmet medical needs and is seeking exceptional team members to build a rapidly growing biotech. The Principal Scientist, Bioanalytical will lead the development and execution of bioanalytical strategies supporting the company's pipeline, playing a critical role in advancing preclinical and clinical programs by leading and overseeing assay development, biomarker strategies, and data interpretation. The ideal candidate should possess deep scientific expertise, strong leadership capabilities, and experience in a fast-paced biotech environment. Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation, representing an entirely new class of therapeutics for severe diseases across numerous therapeutic areas.

Requirements

Ph.D. in Biology, Pharmacology, Bioanalytical Chemistry, or related field with 8+ years of relevant industry experience (or Master’s with 12+ years)
Deep expertise in development, qualification and validation in bioanalytical, biomarker analysis and potency assays
In depth understanding of frequently used techniques such as qPCR, digital PCR, ligand binding assays, LC-MS/MS, flow cytometry, reporter gene assays
Strong understanding of PK/PD principles and translational science
Experience managing CROs and external partners
Familiarity with regulatory requirements for bioanalytical methods and submissions (FDA, EMA)
Proven ability to lead programs and work cross-functionally in a fast-paced environment
Excellent communication, leadership, and organizational skills
Ability to think strategically while remaining hands-on when needed

Nice To Haves

Experience supporting gene therapy, cell therapy, or nucleic acid-based therapeutics strongly preferred

Responsibilities

Lead the design, development, qualification, and validation of bioanalytical assays to support preclinical and clinical studies, including PK/PD and biomarker assessments.
Develop and execute bioanalytical strategies to support therapeutic programs, ensuring alignment with overall program objectives and regulatory expectations.
Oversee sample analysis and data interpretation, ensuring high-quality, reproducible results to inform decision-making.
Support cell-based potency assay development to support clinical studies and early indications
Troubleshoot complex analytical issues, optimize assay performance, and maintain laboratory efficiency and data integrity.
Participate in strategic planning for technology implementation, and scientific innovation within the bioanalytical department
Collaborate cross-functionally with R&D, Clinical Development, Regulatory, and Translational teams to integrate bioanalytical insights into program strategy.
Manage external CROs and vendors, including selection, oversight, and performance management to ensure timelines and quality standards are met.
Contribute to regulatory submissions by preparing bioanalytical sections of INDs, CTAs, and other filings.
Stay current with emerging technologies and trends in bioanalysis, incorporating innovative approaches where appropriate.
Mentor and guide junior scientists, fostering a collaborative and high-performing team environment.
Present data and insights to senior leadership and external stakeholders, clearly communicating complex scientific concepts.
Ensure compliance with GLP/GCP standards and internal quality systems.