The Role
Lead aseptic sterile drug product process development, validation (PPQ), technology transfer, and commercial support. Perform statistical analysis (JMP/Minitab), author validation/technical reports, drive contamination control and GMP compliance, and coordinate cross-functional teams to enable manufacturing readiness and continuous process improvement.
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, Chemical, Biomedical, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or related; PhD or Master's with 3+ years or Bachelor's with 5+ years relevant experience
- Experience with statistical software JMP or Minitab
- Experience with Sample Management Systems such as LIMS and HLEE
- Experience supporting sterile drug product manufacturing in pharma or biotech
- 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, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems
- 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 supporting commercial readiness and continuous improvement
- Experience with single-use technologies, filling equipment, and sterile manufacturing operations
- Fully bilingual in English and Spanish
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
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.
