Director of Oligonucleotide Manufacturing

2 weeks ago


Cambridge, Massachusetts, United States QurAlis Full time
About QurAlis

We are a clinical-stage biotechnology company advancing a pipeline with therapeutic candidates that target specific components of ALS and FTD pathology and defined patient populations based on both disease-causing genetic mutation(s) and clinical biomarkers.

Job Summary

The Director of Drug Substance Manufacturing at QurAlis plays a pivotal role in developing and optimizing chemical processes for Oligonucleotides production and overseeing the refinement of external manufacturing processes.

Key Responsibilities
  • Oversee the operation of drug substance manufacturing at our Contract Manufacturing Partners, ensuring compliance with all regulatory, safety, and quality standards.
  • Develop and optimize scalable chemical processes for the synthesis of drug substances, focusing on efficiency, yield, and purity.
  • Direct the planning and implementation of process development, scale-up, technology transfer, and validation efforts in drug substance manufacturing, ensuring strategic alignment and operational excellence.
  • Collaborate with cross-functional teams, including analytical development, formulation development, quality assurance, and regulatory affairs, to ensure seamless project progression.
  • Manage relationships with contract manufacturing organizations and ensure they meet our quality and production requirements.
  • Prepare technical reports and presentations to communicate results and progress to internal and external stakeholders.
Requirements
  • Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent, with significant experience in Oligo chemistry.
  • Proven track record in Active Pharmaceutical Ingredient process development, including scale-up and technology transfer, coupled with a deep understanding of synthetic organic chemistry.
  • Deep understanding of regulatory requirements and quality standards in pharmaceutical manufacturing.
  • Experience in working with CMOs and managing external partnerships.
  • Excellent communication, organizational, and project management skills.


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