Process Engineer

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 highly creative, passionate, and motivated individual to join us in our quest to develop the next generation of CRISPR-based therapeutics. The current role is for a Process Engineer I to join our team and advance our platform.The candidate will join the Process Sciences Drug Substance team to contribute to and lead the development of key unit operations of mRNA CRISPR by Design™ platform processes. We seek enthusiastic, creative, and highly motivated individuals comfortable working in a fast-paced entrepreneurial CMC environment. Additionally, the candidate is expected to have a good understanding and strong knowledge of downstream process development

The candidate will have numerous opportunities for professional growth in a rapidly growing biotechnology start-up, which includes growing into a leadership role of increasing responsibilities and the ability to publish highly impactful work in peer reviewed journals. 

Key Responsibilities:

• Design, develop, and characterize mRNA unit operations for the manufacture of mRNA Drug Substance, including TFF, plasmid linearization, In Vitro Transcription, chromatography, and filtration process steps
• Possess strong skills in the execution of experiments using Quality by Design (QbD) and Design of Experiments (DoE) to develop high-quality robust and scalable mRNA Drug Substance processes
• Utilize QbD principles to identify CPP/KPP’s, support process understanding and DoE methodologies to investigate process variables and optimize conditions
• Execute routine in-process assays and understand complex analytical methods to analyze experimental data and draw meaningful conclusions to guide process improvements
• Draft Development Reports, SOPs, protocols and support drafting of Tech Transfer documents (Process Description, Process Transmittal)
• Proactively collaborate with CDMOs in transfer of information, materials, drug substance technology to facilitate tech transfer of mRNA Drug Substance mRNA processes  
• Maintain accurate and detailed records of all experiments and process development activities in appropriate formats (Benchling, Development Reports, and presentations)
•   Work collaboratively & communicate key findings in a multi-disciplinary environment with Process Science teams (Drug Substance/Product, Analytical Development), Quality and Research teams to assist multiple groups in the development and execution of study plans
•   Ability to work independently and prioritize tasks to drive multiple projects to support pipeline development and timeline deliverables
•   Stay updated on the latest advancements in mRNA bioprocess technologies, identify opportunities for process improvements and implement innovative solutions to enhance efficiency, product quality, and cost-effectiveness
•   Share responsibility for lab management activities (ordering supplies, ensuring instruments are calibrated and maintained, making reagents and buffers/solutions)
• Use software such as PRISM, JMP, OpenLab CDS, Unicorn for data analysis and operational execution
• Effectively collaborate with members within a fully integrated team to facilitate execution on projects within established timelines
• Foster a driven, fast-paced, dynamic, and fun environment in which to do rigorous science

Required Skills and Background:

• Experience of biologics purification using chromatography is required
• Experience in large molecule Drug Substance development is required
•  Experience working within CMC and Process Science (Process Development, Tech Transfer, Analytical Development, Quality and/or GMP manufacturing) teams is required
• Demonstrated quantitative and scientific thinker as evidenced by a strong publication record
• Ability to work both independently and collaboratively in a fast-paced, interdisciplinary research team

Preferred Skills and Background:

•  Biochemistry, Engineering or related discipline; BS with 5+ years, MS with 3+ years or Ph.D. with 0+ years of relevant industry experience 
• Familiarity with CRISPR technologies and therapeutic approaches
• Familiarity with protein or RNA structure and engineering approaches

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 $80,000-95,000 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.