Senior Scientist, Process Development

Kudo Biotechnology Inc. (Kudo) is a global mRNA contract development and manufacturing organization (CDMO). Kudo has a state-of the-art clinical GMP manufacturing facility and manufacturing sciences & analytical technology (MSAT) laboratories in Shanghai, China, as well as process development laboratories in Boston.

At our site in Needham, Kudo operates mRNA / LNP process and analytical development labs.

Check out the role overview below If you are confident you have got the right skills and experience, apply today.

About the role

We are seeking a highly motivated downstream scientist to play a key role as part of Kudo’s process development team. As a senior scientist, you will design and implement scalable RNA production / purification process allowing for high quality RNA products.

The successful candidate will have a demonstrated background of nucleic acid purification process development and working knowledge of identifying / establishing CPPs using QbD principles.

This role is primarily a lab-based position, and you will work in a cross-functional team and interface with internal and external stakeholders to accelerate the development effort.

Responsibilities :

1. Develop robust, scalable, and well-characterized RNA purification processes using QbD principles that can be scaled up and transferred to MSAT labs.

2. Evaluate new technologies and methods related to improved RNA purification based on both experimental results and literature search.

3. Design and execute process optimization / characterization studies using DOE approach.

4. Lead / support technology transfer activities of manufacturing processes between internal and external sites. Provide technical support for investigations.

5. Stay aware of the latest process technologies and new DNA / RNA modalities through publications, presentations, patents, and industry workshops to assist with business development activities.

6. Perform data analysis, troubleshooting experiments, and recording results in electronic lab notebook. Share data within the team with high quality and clarity.

7. Author SOPs, reports, technical documents, and regulatory submissions as needed.

8. Collaborate across multiple cross functional teams. The ability to effectively communicate within a project team and with external partners is expected.

9. Provide guidance and training to junior team members.

Qualifications :

1. MSc with 7+ years or Ph.D. with 5+ years of relevant laboratory experience.

2. Exhibited experience within the industry handling bioprocess development and process technology transfer for biomacromolecules such as mRNA, pDNA, siRNA, proteins, or viral gene therapy.

3. Extensive hands-on experience with different purification / separation techniques such as chromatography and tangential flow filtration (TFF) and associated instrumentation such as AKTA chromatography systems and Unicorn software.

4. Familiar with statistical software such as JMP, DOE software such as MODDE for both manufacturing process analysis as well as statistical experiment design.

5. Working knowledge of QbD, DOE, nucleic acid chemistry, and enzymatic reactions.

6. Broad understanding of analytical / QC methods required for CMC support.

7. Knowledge of the regulatory environment and cGMP requirement on risk management, technology transfer and process validation is a plus.

8. Excellent written and oral communication skills.

9. Self-starter, execution focused, team oriented, with an ability to thrive in a diverse, fast paced, and multicultural environment.

Please email a cover letter and resume to [email protected]

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