The Role
Designs, implements, and executes experiments to support biopharmaceutical process development. Provides technical support to commercial manufacturing (formulation and aseptic filling), monitors processes, analyzes data (JMP), supports investigations and root-cause analysis, prepares regulatory documentation, and provides on-floor 24/7 manufacturing support while collaborating cross-functionally. Bilingual Spanish/English required.
Summary Generated by Built In
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
Skills Required
- Ph.D. in a relevant scientific discipline
- Master's degree with 2+ years of relevant scientific experience
- Bachelor's degree with 4+ years of relevant scientific experience
- Relevant experience in a commercial biopharmaceutical manufacturing environment
- Experience 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 and cross-functional collaboration skills
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The Company
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
