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Process Development Scientist – Drug Substance

Working in collaboration with cross functional teams, the Process Development Scientist will assist with technical aspects of technology transfer and support startup of the facility in the short term. Longer term, the Process Development Scientist will provide on-floor practical technical support for the drug substance production processes, optimization and improvement of procedures, process characterization, experimentation and process validation support in support of commercialization. This individual will have an opportunity to work across all steps within the drug substance production process (upstream and downstream). In addition, there will be opportunities to participate within important projects within the drug proceed process as they arise.

Key responsibilities:

  • Act as the accountable point of contact from the Process Development Organization for product/process support for technology transfers and ongoing cGMP drug substance manufacturing.
  • Use technical experience to trouble shoot issues with drug substance processing technologies and equipment.
  • Optimize and execute robust bench and pilot scale process steps including cell build, production bioreactor, and purification techniques such as filtration and chromatography.
  • Collaborate with manufacturing, QA and F&E and other process development personnel to support and improve process steps within the production process.
  • Work with the Process Development teams (UK and US) to characterize and define the critical parameters of the process steps.
  • Author protocols, reports, risk assessments, SOPs, and batch records
  • Drive continuous improvement in our cGMP process steps through technological innovation and application of experimental findings
  • Identify, evaluate, and implement new and existing technologies to improve process efficiency, control and understanding

Education and Experience:

  • Master’s degree and 4 or more years of related work experience, or
  • Bachelor’s degree and 6 or more years of related work experience
  • Minimum of 2 years working in a biologics drug substance process development / manufacturing support role
  • Experience with single-use manufacturing technologies
  • Experience conducting process characterization with minimal supervision

EEO & Employment Eligibility:

Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Recruitment/Staffing Agencies:

Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.