The Role
Support commercial biopharmaceutical manufacturing with emphasis on formulation and aseptic filling. Monitor processes, troubleshoot issues, lead investigations and root-cause analysis, drive continuous improvements, ensure GMP/regulatory compliance, prepare inspection documentation, and collaborate cross-functionally while supporting floor operations and variable shifts.
Summary Generated by Built In
We are seeking a Process Development Scientist to provide technical support for commercial bio pharmaceutical manufacturing operations, with a primary focus on formulation and aseptic filling processes. This role is responsible for process monitoring, troubleshooting manufacturing issues, supporting investigations, and driving continuous process improvements while ensuring compliance with quality and regulatory requirements. The scientist will collaborate with cross-functional teams to support safe, efficient, and compliant manufacturing operations.
Requirements
- Must meet one of the following education and experience requirements: Doctorate (Ph.D.) in a scientific discipline; or Master's degree in a scientific discipline with 2+ years of relevant scientific experience; or Bachelor's degree in a scientific discipline with 4+ years of relevant scientific experience.
- Experience in a commercial bio pharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
- Understanding of protein science, formulation processes, and aseptic filling operations
- Experience with process monitoring, data analysis, trending, and statistical software (e.g., JMP)
- Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
- Experience providing direct manufacturing floor support in a fast-paced, GMP-regulated production environment.
- Strong technical writing skills with experience preparing documentation for regulatory inspections and audits.
- Excellent communication, presentation, problem-solving, and project management skills.
- Demonstrated ability to collaborate effectively with cross-functional teams.
- Bilingual proficiency in English and Spanish (written and verbal).
- Work schedule: 8:00 am to 5:00 pm (admin shift). However, staff will support a 24/7 formulation and filling operations, and irregular shifts, including extended hours (12 hrs), nights, weekends, or holidays may be required based on business needs.
Skills Required
- Doctorate (Ph.D.) in a scientific discipline; or Master's with 2+ years relevant scientific experience; or Bachelor's with 4+ years relevant scientific experience
- Experience in commercial biopharmaceutical manufacturing, preferably formulation and aseptic filling
- Understanding of protein science and formulation processes
- Experience with process monitoring, data analysis, trending, and statistical software (e.g., JMP)
- Experience supporting deviations, investigations, root cause analysis, and product impact assessments
- Direct manufacturing floor support experience in a fast-paced, GMP-regulated production environment
- Strong technical writing skills for regulatory inspections and audits
- Excellent communication, presentation, problem-solving, and project management skills
- Demonstrated ability to collaborate effectively with cross-functional teams
- Bilingual proficiency in English and Spanish (written and verbal)
- Willingness to support 24/7 operations and irregular shifts including nights, weekends, holidays, and extended hours
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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.
