Senior Scientist, Drug Product Development & External Manufacturing

Title: Senior Scientist, Drug Product Development & External Manufacturing

Location: Cambridge, MA (on-site)

Reports To: VP/Director, CMC

Judo Bio is pioneering oligonucleotide medicines delivered to the kidney, opening the way for new RNA medicines for systemic and renal diseases. With our STRIKE (Selectively Targeting RNA Into Kidn Ey) platform, we use a proprietary approach that harnesses a natural, endogenous mechanism to target oligonucleotide medicines to the kidney.

Our initial drug programs are ligand-siRNA conjugate drugs designed for receptor-mediated uptake by specific kidney cell types, resulting in gene silencing of disease-modifying target genes for systemic diseases.

Enabled by a network of high caliber experts and internal talent, we are thoughtfully building a team of passionate, innovative, and energetic scientific champions to discover and develop therapeutics that have the potential to change the lives of patients and families.

Judo Bio is seeking highly motivated Senior Scientist (title to commensurate with experience) with 4-8+ years of industry experience focused on injectable formulation development to support our siRNA programs (discovery through IND-enabling). Reporting to the VP/Director, CMC, this individual will drive drug product formulation design and development, analytical characterization, external scale up and manufacturing of our siRNA formulations. The successful candidate will also serve as a critical interface between internal scientific teams and external partners to advance multiple pipeline programs.

May include some or all of the following:

• Help design and build internal lab capabilities for oligonucleotide drug product formulation development, including formulation design, process optimization and troubleshooting to enhance product performance.
• Plan and execute DP formulation development studies to select Phase appropriate DP Presentation
• Prepare and evaluate injectable formulations to support high value preclinical in vivo studies (rodent and NHP).
• Support internal analytical characterization of critical drug substance (DS) and drug product (DP) properties to support development objectives.
• Coordinate technical activities and communication with internal stakeholders and external CDMO partners to support process development, manufacturing, and scale-up activities.
• Ensure seamless and efficient technology transfer and GMP manufacturing of oligonucleotides DP while maintaining stringent quality standards
• Author CMC documentation and regulatory submissions (e.g., IND-enabling activities) to support global regulatory activities.

• PhD in Pharmaceutical Sciences, Chemical Engineering, Chemistry or related discipline. (MS candidates with substantial relevant industry experience will also be considered)
• 4–8+ years of relevant industry experience in pharmaceutical or biotechnology formulation development.
• Hands-on experience with oligonucleotide and/or conjugates formulation development is a plus
• Working knowledge of phase-appropriate CMC development and familiarity with regulatory documentation.
• Experience working with CDMOs and external development/manufacturing partners is preferred.
• Strong scientific judgment, problem-solving ability, and attention to detail, with the ability to work effectively in a fast-paced, collaborative environment.

• Ability to effectively manage time and prioritize tasks independently in a fast-paced environment
• Communicate technical expectations clearly, identify project risks and establish the risk mitigation plans

This is a high-impact role offering significant visibility and influence across CMC strategy and execution. You will play a direct role in advancing innovative oligonucleotide therapeutics into the clinic, working within a collaborative, fast-paced environment that values scientific rigor, ownership, and execution.

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Judo Bio recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Judo Bio in the United States will be considered without regard to citizenship/alienage.