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.

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 Scientist/Senior Scientist, Process Development to develop, and manufacture, and ensure timely delivery of products under program timelines. The position will report into the Director, Bioprocess Development.

Responsibilities:

  • 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; lab fermenters, 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

Qualifications:

  • 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

Required Skills/Experience:

  • A proven track record in aseptic processing of microorganisms, operation of bench scale fermenters and bioreactors, centrifugation, cross-flow filtration and preparative HPLC.
  • Demonstrated experience in application of DOE methodology and advanced statistical analysis
  • Experience in performing routine in-process assays e.g. HPLC, nutrient / metabolite concentration, 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

Personal Characteristics:

  • Agility: Ability to work in a high energy organization with evolving goals and deliverables
  • Results Oriented: Self-motivated, curious, accomplishes goals with minimal oversight
  • Communication: Outstanding written and verbal communication skills, ability to work well with colleagues from diverse backgrounds and cultures
  • Authenticity: Ability to voice their opinion and provide insight to the broader team, even when holding a minority or “out of the box” opinion. Ability to thrive with input from a cross-functional team while remaining the unquestioned scientific expert
  • Team player: Desire to routinely interact with and mentor team members
  • Innovative: creativity in implementing innovative approaches

 

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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