The Role
Supports sterile drug product manufacturing through aseptic processing, process characterization, validation, technology transfer, and commercial process support. Analyzes manufacturing data, authors validation and technical documentation, leads investigations and change controls, and drives continuous process improvement. Collaborates with Manufacturing, Quality, Engineering, Regulatory, and Technical Services teams while providing scientific leadership and managing multiple projects in a GMP environment.
Summary Generated by Built In
We are seeking a Senior Process Development Scientist to support sterile drug product manufacturing operations within the pharmaceutical or biotechnology industry. The ideal candidate will have strong expertise in aseptic processing, process characterization, process validation, technology transfer, data analysis, and commercial process support. This role requires the ability to work cross-functionally while providing scientific and technical leadership to support manufacturing readiness and continuous process improvement.
Requirements
- A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred. Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable; or Master's degree with 3+ years of relevant scientific experience; or Bachelor's degree with 5+ years of relevant scientific experience.
- Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE.
- Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
- Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
- Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
- Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
- Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
- Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
- Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
- Strong technical writing, communication, presentation, and project management skills.
- Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
- Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable
- Fully Bilingual (English and Spanish)
Skills Required
- Degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline
- Doctorate such as PhD, PharmD, or MD with relevant postdoctoral experience where applicable
- Master’s degree with at least 3 years of relevant scientific experience
- Bachelor’s degree with at least 5 years of relevant scientific experience
- Experience with JMP or Minitab and sample management systems such as LIMS and HLEE
- Experience supporting sterile drug product manufacturing in the pharmaceutical or biotechnology industry
- Hands-on experience with aseptic filling operations, process characterization, process validation, technology transfer, and commercial process support
- Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls
- Knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems
- Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization
- Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions
- Experience working cross-functionally with Manufacturing, Quality, Engineering, Regulatory, and Technical Services
- Strong technical writing, communication, presentation, and project management skills
- Ability to independently manage multiple projects in a fast-paced manufacturing environment
- Experience with single-use technologies, filling equipment, and sterile manufacturing operations
- Full bilingual proficiency in English and Spanish
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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.
