Molecular Process Engineer

2 weeks ago

Fremont, California, United States Scribe Therapeutics Full time
Job Overview

Scribe Therapeutics is at the forefront of molecular engineering, dedicated to pioneering innovative in vivo therapies aimed at addressing the root causes of diseases. Founded by leading figures in CRISPR technology, our mission is to transcend the limitations of existing genome editing methods through the development of custom-engineered enzymes and delivery systems, forming the basis of our proprietary CRISPR by Design™ platform.

We are in search of a dynamic, inventive, and driven individual to join our team as a Process Engineer I. This role is pivotal in advancing our mRNA CRISPR by Design™ platform processes. The successful candidate will become part of the Process Sciences Drug Substance team, contributing to and spearheading the development of essential unit operations.

We are looking for enthusiastic and highly motivated individuals who thrive in a fast-paced, entrepreneurial environment. A solid understanding of downstream process development is essential for this position.

Key Responsibilities:

  • Design and optimize mRNA unit operations for the production of mRNA Drug Substance, encompassing processes such as TFF, plasmid linearization, In Vitro Transcription, chromatography, and filtration.
  • Demonstrate proficiency in executing experiments utilizing Quality by Design (QbD) and Design of Experiments (DoE) methodologies to create robust and scalable mRNA Drug Substance processes.
  • Apply QbD principles to identify Critical Process Parameters (CPP) and Key Process Parameters (KPP), enhancing process understanding and optimizing conditions through DoE.
  • Conduct routine in-process assays and utilize complex analytical methods to interpret experimental data, guiding process enhancements.
  • Prepare Development Reports, Standard Operating Procedures (SOPs), and protocols, while supporting the drafting of Tech Transfer documents.
  • Collaborate proactively with Contract Development and Manufacturing Organizations (CDMOs) to facilitate the transfer of information and technology for mRNA Drug Substance processes.
  • Maintain meticulous records of all experiments and development activities using appropriate documentation tools.
  • Work collaboratively with cross-functional teams, sharing insights and findings to support the development and execution of study plans.
  • Independently manage tasks and prioritize projects to meet pipeline development goals and timelines.
  • Stay informed on advancements in mRNA bioprocess technologies, identifying opportunities for improvements and implementing innovative solutions.
  • Participate in lab management tasks, including supply ordering and instrument maintenance.
  • Utilize software tools for data analysis and operational execution.
  • Foster a collaborative and dynamic work environment that encourages rigorous scientific inquiry.

Required Skills and Qualifications:

  • Experience in biologics purification through chromatography is essential.
  • Proven background in large molecule Drug Substance development is required.
  • Experience in CMC and Process Science, including Process Development, Tech Transfer, Analytical Development, and Quality is necessary.
  • Strong analytical and scientific thinking skills, demonstrated by a solid publication record.
  • Ability to work both independently and as part of a collaborative, interdisciplinary research team.

Preferred Skills and Qualifications:

  • A degree in Biochemistry, Engineering, or a related field; BS with 5+ years, MS with 3+ years, or Ph.D. with relevant industry experience.
  • Familiarity with CRISPR technologies and therapeutic applications.
  • Understanding of protein or RNA structure and engineering methodologies.

We are committed to fostering a diverse workplace and are proud to be an equal opportunity employer. All qualified applicants will be considered for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.

Compensation will be commensurate with experience, and we offer a stimulating and collegial work environment. Join us in shaping the future of therapeutics.

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