Principal Scientist, Oligonucleotide (PMO, ASO) Development

Key Responsibilities

• Drive Process Excellence: Lead the design, optimization, and execution of process development for PMO and modified ASO payload molecules, ensuring scalability for clinical supply.
• Define Analytical Strategy: Support analytical development, focusing on robust impurity control strategies, raw material specifications, and comprehensive physicochemical characterization for both oligonucleotide payloads and conjugated protein drug substances.
• Innovate & Improve: Proactively identify and implement emerging technologies and continuous improvement initiatives to enhance product quality and manufacturing efficiency.
• Prepare technical source documents, publications, and oral presentations.
• Prepare and review relevant CMC and product related sections and documentation for regulatory submission (IND, IMPD etc.).
• Review and approve documents related to development and cGMP operations, including Tech Transfer, Process Characterization, Master Batch Records (MBRs) and Campaign Summary Reports.

External Partner & Project Management

• Technology Transfer: Spearhead the seamless transfer of processes and analytical assays to external partners, ensuring technical success and data integrity.
• Serve as the technical lead for resolving complex manufacturing or analytical challenges, driving timely and data-driven solutions.

Regulatory & Quality Compliance

• Regulatory Authoring: Contribute to regulatory filings (IND, IMPD, etc.), ensuring high-quality, submission-ready Module 3 content.
• GMP Oversight: Review and approve critical development and cGMP documentation, including Tech Transfer protocols, Master Batch Records (MBRs), and Campaign Summary Reports.

Knowledge Dissemination

• Oversee the creation of technical source documents, publications, and high-level presentations for internal stakeholders and external forums.

Education & Experience

Bachelor’s degree in Biochemistry, Chemical Engineering, Chemistry, or Pharmaceutical Sciences
8+ years of relevant pharmaceutical/biotech industry experience (advanced degree preferred)

Proven track record in the process chemistry and development of PMO and modified ASO oligonucleotides, including deep technical knowledge of synthesis and purification.

Experience in Research & Development preferably in a clinical-stage biotechnology company

Direct experience in the oversight of CDMOs, including managing technology transfers.

Technical proficiency in analytical development, including impurity control strategies and physicochemical characterization of payload and conjugated drug substances.

Ability to navigate shifting priorities and evolving timelines using robust analytical and risk-mitigation capabilities.

Exceptional interpersonal and communication skills, with a proven ability to lead and influence cross-functional teams, contractors, and third-party vendors.

Pay Range

$159,000 - $200,000 USD