Senior Scientist, Drug Product Development & External Manufacturing

Judo Bio; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Judo Bio in Cambridge, MA is seeking a Senior Scientist to lead injectable formulation development for siRNA programs, reporting to CMC leaders. You will drive DP formulation design, analytical characterization, and external scale-up with CDMOs.

This role interfaces with internal teams and external partners to advance pipeline programs, author CMC documentation, and support IND-enabling activities in a fast-paced, collaborative environment.

Qualifications

• PhD or equivalent experience in pharmaceutical sciences or related field.
• 4–8+ years of industry experience in formulation development for biotech/pharma.
• Experience with oligonucleotide and conjugate formulations is a plus.
• Familiarity with phase-appropriate CMC development and regulatory documentation is required.

Responsibilities

• Design and build internal lab capabilities for oligonucleotide DP formulation development.
• Plan and execute DP formulation development studies for phase-appropriate DP presentation.
• Prepare and evaluate injectable formulations for preclinical studies (rodent and NHP).
• Support analytical characterization of critical DS/DP properties.
• Coordinate activities with internal teams and external CDMOs for process development and scale-up.
• Author CMC documentation and support IND-enabling regulatory work.

Skills

Formulation design

Oligonucleotides

External collaboration

Regulatory documentation

Education

PhD in Pharmaceutical Sciences

MS with substantial industry experience

Tools

HPLC/LC-MS

Job description

Title: Senior Scientist, Drug Product Development & External Manufacturing

Location: Cambridge, MA (on-site)

Reports To: VP/Director, CMC

About Judo Bio

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 KidnEy) 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.

Position Overview

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.

Key Responsibilities

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.

Qualification

• 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.

Other Skills

• 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

Why Join US

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.

Tips: Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.

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.