Selecta Biosciences
  • Watertown, MA, USA
  • Full Time

 Process Development Engineer I

  NO PHONE CALLS OR AGENCIES

Selecta Biosciences is seeking a talented and dedicated Process Development Engineer to join our fast paced and growing company!  Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company focused on developing biologic therapies for rare and serious diseases that avoid the immune responses that compromise efficacy and lead to life-threatening complications. Selecta is applying its proprietary Synthetic Vaccine Particles (SVP) to a range of therapeutic areas in which immunogenicity is a key challenge. Our lead program SEL-212 is in phase 2 clinical development for patients with severe forms of gout. Our two fast advancing gene therapy product candidates for inborn errors of metabolism (MMA and OTC) have the unique potential to enable repeat administration, allowing for dose adjustment in patients and maintenance of therapeutic activity over time.

Summary

In this newly created position, the Process Development Engineer will work on developing and scaling up a process for manufacturing synthetic particles, as well as working on the technology transfer to contract manufacturing organizations (CMOs) to prepare clinical trial drug product.

 Principal Duties/Responsibilities 

  • Demonstrates knowledge of chemical engineering unit operations required for product development
  • Drafts experimental plans, executes and documents experiments, analyzes data, and writes technical reports
  • Contributes to the technology transfer to CMOs
  • Records all data, calculations and experiments directly into laboratory notebooks in a timely basis
  • Contributes to the design and review of process equipment
  • Assists in executing pilot and clinical manufacturing processes
  • Communicates results within Process Development group and to other groups throughout the company as required
  • Responds to process and equipment related issues during manufacturing
  • Verifies that all equipment and processes are properly configured prior to manufacturing
  • Writes batch records and standard operating procedures
  • Maintains laboratory and process equipment as required by cGMP
  • Represents Process Development group on project teams to provide team with knowledge of process capabilities and general engineering support
  • Completes high-quality work according to aggressive timelines
  • Travels to CMO locations as needed
  • Maintains laboratory in compliance with all Company, state, and federal requirements
  • Performs duties according to applicable Company safety procedures
  • Performs other duties as necessary

Educational and/or Experience

  • Bachelor's Degree or higher in Chemical Engineering or related discipline
  • 0 3 years of experience in process development in the pharmaceutical industry preferred
  • Experience with homogenization and tangential flow filtration is valuable
  • Ability to work on multiple projects simultaneously
  • Ability to work with minimal supervision on ongoing assignments

Work Environment

The position requires hands-on work setting up and operating process equipment in an R&D laboratory and traveling to CMOs to work in their clean rooms. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory.

The Company has active programs on developing novel immunotherapies for various food and environmental allergies. An employee may be required to work with and/or be exposed to allergens in the laboratory.

Qualified candidates should apply online at www.selectabio.com/careers. 

About Selecta Biosciences, Inc.

Selecta Biosciences, Inc. is a clinical-stage biopharmaceutical company that is focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses. Selecta plans to combine its tolerogenic Synthetic Vaccine Particles (SVP) to a range of biologics for rare and serious diseases that require new treatment options. The company's current proprietary pipeline includes SVP-enabled enzyme, oncology and gene therapies. SEL-212, the company's lead candidate in Phase 2, is being developed to treat severe gout patients and resolve their debilitating symptoms, including flares and gouty arthritis. Selecta's clinical oncology candidate, LMB-100, is in a Phase 1 program targeting pancreatic cancer and mesothelioma. Its two proprietary gene therapy product candidates are being developed for rare inborn errors of metabolism and have the potential to enable repeat administration. The use of SVP is also being explored in the development of vaccines and treatments for allergies and autoimmune diseases. Selecta is based in Watertown, Massachusetts. For more information, please visit http://selectabio.com and follow @SelectaBio on Twitter.

NO PHONE CALLS OR AGENCIES PLEASE. 

Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).

 

Selecta Biosciences
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