Process Development Scientist

QRC Group, LLCJuncos, PR
Onsite

About The Position

We are seeking a Process Development Scientist to join our team. In this role, you will conceive, design, implement, and execute scientific experiments that contribute to the successful completion of project and organizational goals. The successful candidate will work under the general guidance of a supervisor while providing scientific and technical support to manufacturing operations in a commercial bio pharmaceutical environment.

Requirements

  • Doctorate (Ph.D.) in a relevant scientific discipline; or Master's degree with 2+ years of relevant scientific experience; or Bachelor's degree with 4+ years of relevant scientific experience.
  • Relevant experience in a commercial bio pharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
  • Understanding of protein science, formulation and filling processes.
  • Experience with process monitoring, data trending, and statistical analysis tools (e.g., JMP)
  • Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
  • Ability to provide manufacturing floor support in a fast-paced, 24/7 operation.
  • Bilingual in Spanish and English (written and verbal).
  • Strong technical writing skills with experience preparing documentation for regulatory audits.
  • Excellent communication, presentation, problem-solving, project management skills and cross-functional collaboration skills.

Responsibilities

  • Conceive, design, implement, and execute scientific experiments that contribute to the successful completion of project and organizational goals.
  • Provide scientific and technical support to manufacturing operations in a commercial bio pharmaceutical environment.
  • Support deviations, investigations, root cause analysis, and product impact assessments.
  • Provide manufacturing floor support in a fast-paced, 24/7 operation.
  • Prepare documentation for regulatory audits.
  • Communicate, present, problem-solve, manage projects, and collaborate cross-functionally.
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