Scientist, Downstream mRNA Purification Process Development
Proclinical is urgently recruiting for a Scientist of Downstream mRNA Purification Process Development with a global pharmaceutical company located in Woburn, MA. As the Downstream mRNA Purification Process Development Scientist, you will have the experience leading the efforts of mRNA downstream process development from early-stage process design to late stage GMP process implementation.
- Apply deep knowledge in chromatography, solid-liquid separations, clarification, and tangential flow filtration to lead scalable mRNA downstream process development
- Lead screening, optimization, and scale-up efforts on plasmid isoform separation and mRNA purification after IVT synthesis and enzymatic modifications.
- Design and execute DOE studies & high-throughput screen for purification process improvements and advancements including parameter optimization, scale-up, process window determination and process capability evaluation
- Lead downstream process tech transfer to pilot plant and GMP facility via drafting SOPs, oversee scale-up, verification & validation activities
- Support the development of in-process assay and final product release testing to evaluate mRNA purity profile
- Assist in the development of automated mRNA purification system to support high-speed downstream process screen
- Work closely with cross-functional teams including CMC scientists to develop mRNA production strategies to meet ambitious project timeline.
- Communicate effectively with regular verbal and formal updates to project teams and management.
- Maintain necessary documents including laboratory notebooks, process development reports, technical transfer records, and process related documents.
- Build and promote the company's value and culture, result oriented, work with can-do attitude, team player mentality, constantly inject positive energy into the working environment.
Skills and Requirements:
- Degree in Biotechnology, Bioengineering, or a related scientific field. BS with 10+ years of directly related experience, MS with 8+ years of directly related experience, or PhD with 4+ years (preferred) of directly related experience.
- Strong understanding of purification of biologics, specifically mRNA, including process scale-up. A proven track record of purifying multiple drug modalities is strongly preferred.
- Strong hands-on experience with a wide range of purification techniques for large nucleic acid molecules including affinity capture, ion exchange, hydrophobic interactions, is a must
- Strong hands-on experience with a wide range of downstream techniques including Depth filtration, UF/DF, TFF, is highly desired
- Proficient with ÄKTA systems and UNICORN control software
- Experience in high-throughput screen and DOE statistical tools for process development techniques is highly desired
- Experience with tech Transfer of manufacturing processes is a strong plus
- Experience in cGMP requirements for process development is a strong plus.
- Experience in standard analytical technologies for biologics including HPLC, agarose gel electrophoresis, capillary electrophoresis, qPCR, ELISA is a plus.
- Experience with automated systems and programming is a plus
- Experience in author & technical review on supporting documentations for CMC and regulatory filings is a plus.
- An ability to work independently, meet deadlines and prioritize work effectively. Must be able to thrive and deliver results on goals in a fast-paced, dynamic and highly multi-tasking environment.
- Demonstrated capabilities to implement advance technologies and persist to successful outcomes.
- Experience in large-scale process of mRNA automation synthesis and purification is highly desired
If you are having difficulty in applying or if you have any questions, please contact Phil Sawyer at (+1) 617-545-5923 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.