Principal Scientist, Bioanalytical

Who Are We?

Our company is based on the science of our founder, Stanley Qi, one of the original CRISPR co-inventors who then furthered the technology so that DNA does not need to be cut to accomplish gene regulation. Instead, we regulate the epigenome to suppress and activate multiple genes simultaneously. We are further evolving the platform and leveraging its strengths to address unmet medical needs. 

We are looking for exceptional team members who want an active role in building a rapidly growing biotech.

Title: Principal Scientist, Bioanalytical
Location: South San Francisco, CA

Opportunity:
Epicrispr Biotechnologies is seeking a highly motivated and experienced Principal Scientist, Bioanalytical to lead the development and execution of bioanalytical strategies supporting our pipeline. This individual will play a critical role in advancing preclinical and clinical programs by leading and overseeing assay development, biomarker strategies, and data interpretation. The ideal candidate brings deep scientific expertise, strong leadership capabilities, and experience working in a fast-paced biotech environment.

Roles and 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.

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

Compensation: The salary range for this position is $165,000 to $184,000 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location. 

Epicrispr Biotechnologies is an early-stage biotechnology company developing a novel technology platform that can provide safe and persistent control of targeted gene regulation. Our proprietary platform represents an entirely new class of therapeutics that can be leveraged to treat severe disease across numerous therapeutic areas, including complex diseases impacted by multiple genes.

Epicrispr Biotechnologies provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.