Process Development Sr Scientist ID 35535
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Design, monitor, and conduct strategies for scientific experiments while providing data analysis and interpretation to assess project impact. Develop and implement novel protocols to address specific issues, representing the department on project teams and initiating productive collaborations. Advise others on experimental design and data diagnosis to solve routine technical problems, maintaining current technical expertise through literature monitoring. Execute validation protocols, characterization studies, and change controls within highly regulated sterile drug product manufacturing environments. Analyze manufacturing data using JMP or Minitab to identify trends and recommend process optimizations while managing multiple projects in a fast-paced setting.
Required Qualifications
- Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry
- Validation experience in highly regulated industry
- Experience in filling validation and work on technical documentation
- 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
- 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
- Science background as Engineering or microbiology
Desired Qualifications
- Experience with single-use technologies, filling equipment, and sterile manufacturing operations
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