Process Development Sr Scientist
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Design, execute, and monitor complex experiments to advance sterile drug product manufacturing technologies and process understanding. Prepare novel protocols, analyze manufacturing data using statistical tools like JMP, and recommend scientifically sound actions to drive continuous improvement. Author technical reports, validation protocols, and investigations while supporting aseptic filling and commercial process readiness. Lead department-wide initiatives, mentor junior staff, and collaborate cross-functionally with Manufacturing, Quality, and Engineering teams to ensure GMP-compliant operations. Manage multiple projects simultaneously in a fast-paced environment, fully bilingual in English and Spanish.
Required Qualifications
- Doctorate (PhD, PharmD, MD) with relevant postdoctoral experience where applicable
- Master's degree + 3 years of scientific experience
- Bachelor's degree + 5 years of scientific experience
- Strong foundation in sterile drug product manufacturing, aseptic processing, and contamination control strategy
- Ability to solve complex problems using scientific theory and critical thinking
- Demonstrated capability to independently develop scientific analyses, hypotheses, and solutions
- Strong laboratory skills and experience with process characterization and validation
- Proficiency with Microsoft Office (Excel, Word, PowerPoint)
- Experience with statistical software such as JMP or Minitab
- Familiarity with sample management systems (LIMS, HLEE)
- Ability to interpret large datasets and communicate findings clearly
- Ability to motivate, lead, and supervise others
- Strong project management skills and ability to develop realistic timelines
- Excellent technical writing, communication, and presentation skills
- Fully bilingual in English and Spanish
Desired Qualifications
- Highly Preferred Disciplines: Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or related scientific fields
- Experience supporting sterile drug product manufacturing in pharmaceutical or biotechnology environments
- Hands-on experience with aseptic filling equipment, single-use technologies, and commercial manufacturing operations
- Strong background in process validation (PPQ), technology transfer, and characterization studies
- Demonstrated ability to author and execute validation protocols, technical reports, investigations, and change controls
- Proven success analyzing manufacturing data, identifying trends, and recommending scientifically sound improvements
- Experience working in cross-functional teams and supporting fast-paced, 24/7 operations
- Ability to manage multiple complex projects while maintaining high quality and compliance standards
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.