Scribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers Benjamin Oakes, Brett Staahl, David Savage, and Jennifer Doudna, Scribe is overcoming the limitations of current genome editing technologies by developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by Design™ platform for CRISPR-based genetic medicine.
We are seeking a seeking a Senior Research Associate with experience in analytical chemistry and RNA analytics. The candidate will join the Process Sciences analytical team to help establish and implement early-stage Chemistry, Manufacturing and Controls (CMC) development and manufacturing efforts for non-viral gene editing systems for its CRISPR by Design™ platform. Qualified candidates will have an understanding and strong knowledge of methods and techniques to characterize synthetic oligonucleotides (sgRNA) and/or mRNA using HPLC-UV, LC-MS, PAGE, capillary electrophoresis, ELISA, and other methods. The ideal candidate will have some experience building and transferring drug substance release assays to a CDMO/CRO or to Quality. We are searching for enthusiastic, creative, and highly motivated individuals comfortable working in a fast-paced entrepreneurial CMC environment.
Key Responsibilities:
- Hands-on development and optimization of chromatography-, capillary-, and spectroscopy-based analytical methods to be used for product release, stability, and early CMC support across multiple early-stage programs
- Work with CDMOs and internal stakeholders to develop appropriate methodologies, including stability indicating methods, to support release and stability testing of development candidates for non-clinical and clinical studies
- Manage the transfer and/or validation of analytical methods to CDMOs and independent contract testing laboratories
- Quantitative LC-UV analysis of RNA molecules pre- and post-formulation of lipid nanoparticles (LNP)
- Characterization of synthetic oligonucleotide impurities of sgRNA molecules by ion-pairing reverse-phase (IP-RP) LC-MS to support development of CRISPR therapeutics
- Method development and qualification of 5’-capping and 3’-poly A tail mRNA characterization assays by IP-RP LC-MS
- Data analysis using statistical software such as GraphPad PRISM, JMP, SoftMax Pro, etc.
- Maintain detailed records of experimental methods and data in an electronic laboratory notebook (Benching)
- Participate in authoring reports, test methods, work instructions, and tech transfer to CDMOs
- Share responsibility for basic lab management activities (ordering supplies, ensuring instruments are calibrated and maintained, making reagents)
Required Skills and Background:
- BS with 5+ years of experience, or MS with 3+ years of experience in an industry setting. Degree in Chemistry, Biochemistry, Chemical Engineering, Bioengineering, Pharmaceutical Sciences, or related discipline
- Excellent oral and written communication skills
- Effective organizational and time management skills
- Strong focus and attention to detail
- Ability to work both independently and collaboratively in a fast-paced, interdisciplinary research team
Preferred Skills and Background:
- Familiarity with CRISPR technologies and therapeutic approaches
- Familiarity with protein or RNA analytical methods
- Familiarity with FDA, ICH and EP or other regulatory agency guidance associated with analytical methods
- The ideal candidate has previous experience with tech-transfer of methods to CDMOs
Salary will be commensurate with experience. We will provide an intellectually stimulating, collegial and fast-paced environment. If you are ready to engineer the future of therapeutics, then we are excited to hear from you! Visit us at www.scribetx.com.
We are committed to creating a diverse environment and are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.
At the time of posting, the base pay wage range for this role is $90,000-115,000 per year. The offered pay range will depend on internal equity and the candidate’s relevant skills, experience, qualifications, training, and market data. Additional incentives are provided as part of the complete package in addition to comprehensive medical and other benefits.
