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 Engineer, Drug Product Process Development to develop, and manufacture, and ensure timely delivery of products under program timelines. The position will report into the Director, Bioprocess Development.
The Position:
We are seeking to hire an innovative and highly motivated Process Engineer to join the Process Development and Manufacturing Sciences group at Senda Biosciences in developing scalable processes for novel drug product formulations used in precision targeting of therapeutics. As a member of this team, you can expect to engage deeply in interdisciplinary research. Working as part of a cross-disciplinary team of biologists, engineers, and chemists, the candidate will be primarily responsible for evaluating multiple unit operations such as lyophilization, spray drying, nanoscale mixing and performing drug product dissolution and container closure studies for generating clinical trial material.
Responsibilities
Design and execute experiments related to process improvements and optimization of lead formulations for multiple Senda product modalities e.g. mRNA, protein, gene editors, immunomodulators Develop a scalable and compliant manufacturing process and define process control strategy to identify critical process parameters Explore, develop and scale-up novel drug product processes Develop Characterization methods for formulated drug products in conjunction with Analytical Development Work closely with the research formulation group to increase drug product stability Interact with internal and external groups to manufacture and supply formulations for pre-clinical, GLP-tox and early-phase clinical studies Prepare technical reports and presentations as it relates to process optimization and scale-up to support technology transfer activities Write and review protocols and batch records for drug product processes Author IND filings/regulatory documentation Develop intellectual property, publishing scientific papers and other tasks related to the company's scientific and business interests Occasional nonstandard work hours and travel required
Required Qualifications:
Ph.D. in Pharmaceutics, Life Sciences, Chemical Engineering or related discipline with a minimum 5 years' experience (or MS with 8+ years' experience) Experience designing, executing and analyzing nano particle-based drug delivery systems Prior experience with LNP formulations with nucleic acids, oral solid dosage forms (capsules, tablets) a plus Demonstrated experience with drug product process development e.g. Lyophilization, Tangential Flow Filtration, nanoscale mixing, microfluidics, container-closure development and executing pre-clinical stability studies Preferably has prior experience working with a frozen or lyophilized particle-based drug product Prior experience working with scale-up of complex drug products and managing production at CDMO's Working knowledge of Quality systems, GMP-related requirements and regulatory requirements for CMC and ICH guidelines is desirable Demonstrates creativity and problem-solving skills Ability to work independently, as well as part of a team Organized, detail-oriented, and demonstrated independent thinker who continuously seeks innovative solutions Effective verbal and written communication skills
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.