Senda Biosciences, Inc. is pioneering a new field of medicine called Intersystems Biology.  People are a system of systems—both human and non-human. The constant molecular exchange between the hundreds of trillions of human and non-human cells within us, such as plant and bacterial cells, defines life as profoundly as our genetics. Senda is systematically harnessing these powerful molecular exchanges—the product of millennia of co-evolution—to create new classes of programmable medicines. Built on insights from Intersystems Biology, Senda’s X-VIA™ drug development platform is the first-ever atlas of interspecies exchange mechanisms, enabling next-generation nucleic acid, genetic and protein-based therapies. These therapies will enable new frontiers for medicines, such as programmable tissue targeting beyond the liver for nucleic acid, cell, and gene therapies; tunable immunomodulation for both in vivo immune system stimulation and suppression; repeatable dosing of therapeutic modalities that were previously impossible; and multiple routes of administration, including enabling oral routes for large biomolecules for the first time.

Senda was unveiled by Flagship Pioneering in October 2020, and the company entered into a strategic collaboration with Nestlé Health Science in 2021 focused on novel nutritional therapies for a wide range of metabolic conditions. Senda is based in Cambridge, MA. For more information, please visit sendabiosciences.com or follow us on Twitter or LinkedIn.

The Position:

We are seeking to hire an innovative and highly motivated Senior Scientist 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 X-VIA™ 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.

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