Senior Research Scientist

2 weeks ago


Pune, Maharashtra, India Enzene Biosciences Ltd Full time

Research Scientist - Drug Product Development Opportunity

Enzene Biosciences Ltd is seeking a highly skilled Research Scientist to join our team in Drug Product Development. The ideal candidate will have a strong background in formulation development, device development, and technology transfer.

Key Responsibilities:

  • Develop novel and NIF formulations for liquid/lyophilized protein formulations, including lyophilization cycle development.
  • Plan, execute, and evaluate uf/df processes for high concentration monoclonal antibody formulations.
  • Design and execute product and process development studies, including product contact part compatibility, hold time, freeze-thaw, thermal cycling, agitation, photostability, temperature excursion, in-use, and reconstitution solution studies.
  • Develop scale-down models for drug product manufacturing processes.
  • Evaluate vendors and plan outsource studies, such as filter validation, extractable leachable studies, preservative efficacy testing, and nitrosamine testing.
  • Conduct functionality method testing, including method development and qualification for universal testing machines.
  • Prepare pharmaceutical development reports as per ICH Q8/CTD.
  • Guide teams for product developmental activities.
  • Evaluate vendors for pen devices, auto-injectors, and prefilled syringes.
  • Design verification testing planning and functionality testing of devices as per ISO 11608 and ISO 11040.
  • Perform risk assessments for product contact parts, CCS, elemental impurities, and nitrosamine impurities in finished products.

Requirements:

  • 11+ years of experience in drug product development, formulation development, device development, and technology transfer.
  • M. Pharm in Pharmaceutical Technology or Biopharmaceutical Technology.
  • Strong data interpretation and troubleshooting skills.
  • Sound cross-functional communication skills and interpersonal skills.
  • Ability to work independently, analyze and interpret experimental data, and present/document experimental results at meetings.
  • Experience in leading teams of 1-2 members.
  • Hands-on experience with JMP software and statistical analysis.

About Us:

Enzene Biosciences Ltd is a leading pharmaceutical company dedicated to developing innovative drug products and devices. We are committed to excellence in research, development, and manufacturing.



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