Process Development Scientist
On-siteJuncos, Juncos, Puerto Rico
Job Summary
Conceive, design, and execute scientific experiments to support process development, troubleshooting, and technical support for manufacturing operations including formulation and aseptic filling. Develop novel protocols, perform data analysis and statistical trending using JMP, and independently author regulatory documents, reports, and patents. Provide real-time manufacturing floor support in fast-paced, 24/7 operations while ensuring compliance with cGMP guidelines and applicable regulations. Represent the department on project teams, initiate cross-functional collaborations, and guide others in experimental design and root cause analysis. Fully bilingual (English/Spanish) with a Doctorate or Master's degree required. This 6-month contract role may lead department-wide initiatives and develop supervisory skills.
Required Qualifications
- Doctorate
- Master's + 2 years of scientific experience
- Bachelor's + 4 years of scientific experience
- Chemical Engineering, Mechanical Engineering, Biology, Chemistry, or related scientific discipline
- Experience in commercial biopharmaceutical manufacturing, especially formulation and aseptic filling
- Strong background in deviations, investigations, and root cause analysis
- Experience writing technical protocols, reports, and regulatory documentation
- Ability to provide real-time support on the manufacturing floor in a 24/7 operation
- Excellent communication, presentation, problem-solving, and cross-functional collaboration skills
- Fully bilingual (English/Spanish)
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