About Senda Biosciences
Senda Biosciences, Inc. is uniquely positioned to transform human health by harnessing millions of years of evolution to program targeted, potent and tunable medicines. Nature has provided the codes to program human cells – both from within (mRNA) and from outside – from what surrounds them. The trillions of non-human cells in the human ecosystem have evolved natural nanoparticles that precisely shuttle biomolecules into human cells, providing the missing pieces to fully unlock programmable medicines. Senda’s proprietary platform includes the first-ever atlas of nature-derived programmable systems at the molecular level and across all kingdoms of life – accessing the entire code provided by nature required to program cells. With this platform, Senda is developing a new class of SendRNA™ medicines. The unique properties of these medicines create new frontiers for mRNA therapeutics and vaccines for infectious, genetic, autoimmune, and metabolic diseases and oncology indications – with further potential to transform the gene editing and protein-based therapy landscapes as well. Based in Cambridge, MA, Senda was founded by Flagship Pioneering. For more information, visit sendabiosciences.com or follow us on Twitter and LinkedIn.
Senda is a rapidly growing, fast-paced company with multiple platforms in early-stage development for several therapeutic indications. our Process development group is responsible for the development and manufacture of drug products supporting the company’s clinical development programs. We are currently looking for a (Senior) Process Scientist, Drug Substance Process Development to develop, and manufacture, and ensure timely delivery of products under program timelines. The position will report into the Director, Bioprocess Development.
- Assist in defining process development strategy for Senda’s pipeline products based on scientific knowledge and regulatory guidelines
- Design, and execute process development using Design of Experiment (DOE) methodology coupled with statistical analysis
- Design, develop and execute in-process assays as required
- Operate various process equipment; AKTA purification system, cross-flow systems, etc.
- Manage the day to day execution of laboratory through a combination of hands on work and supervision of technicians.
- Ensure that laboratory equipment is always in a ready to use state
- Work closely with the process development group to ensure timely delivery of results for pre-clinical studies and ongoing process development activities
- Responsible to transfer the process to CMOs.
- Identify, investigate and resolve any issues in a timely and efficient manner during process development & manufacturing.
- Assist in the preparation of relevant CMC sections of regulatory submissions
- Keep abreast of new innovations and ensure timely evaluation of novel technologies
- Attend and Present at scientific conferences
- Non standard working hours and travel to contract manufacturing sites may be required occasionally
- PhD in biological sciences or biochemical engineering with 0 to 4 years industry experience in process development and characterization in the Pharma / Biotech Industry or
- S./M.S in in biological sciences or biochemical engineering and 7+ years of Pharma / Biotech experience in process development and characterization
- A proven track record in operating chromatography, ultrafiltration, normal flow filtration, and development of innovative unit operations
- 1-2 years of experience in mRNA drug substance process development
- Knowledge of process scale-up, scale-down model development, and process characterization
- Demonstrated experience in application of DOE methodology and advanced statistical analysis
- Experience in performing routine in-process assays e.g. HPLC, RNA gel analysis, endotoxin testing, etc.
- Experience in Set-up and troubleshooting process equipment
- Proficient using Microsoft Office suite, DOE and other relevant software
- Thorough knowledge of biopharmaceutical cGMPs
Senda Biosciences is an Equal Opportunity Employer. Senda does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, national origin, veteran status, or any other status protected under federal, state, or local law.