Process Development Scientist- Drug Substance Purification
On-site · Juncos, Juncos, Puerto Rico
Job Summary
Process Development Scientist for Drug Substance Purification: contribute to process development, technology transfers, and data-driven improvements to Drug Substance manufacturing. Duties include deviations investigations and root-cause analysis, developing and optimizing methods and protocols, authoring technical documents and regulatory-support materials, staying current with literature and internal best practices, and collaborating cross-functionally with Manufacturing, Quality, Engineering, and Process Development. Present data analyses and conclusions to internal teams; ensure work meets safety, quality, regulatory, and cGMP expectations; support safety programs, continuous improvement, recruiting, and knowledge sharing. Requires strong scientific background, experience in biopharmaceutical process development or related manufacturing support, familiarity with cGMP and regulatory expectations, data-driven decision making, and excellent communication skills in English and Spanish. Flexibility for non-standard shifts or manufacturing operations. Proficiency with Word, Excel, PowerPoint, and data visualization or statistical tools; ability to manage priorities and timelines in a collaborative environment.
Required Qualifications
- Basic Qualifications: Doctorate degree OR Master’s degree and 2 years of scientific, process development, laboratory, or manufacturing support experience OR Bachelor’s degree and 4 years of scientific, process development, laboratory, or manufacturing support experience
- Preferred Qualifications: Background in Life Sciences, Biotechnology, Chemical Engineering, Biochemical Engineering, Biology, Chemistry, or related discipline
- Experience in biopharmaceutical process development, Drug Substance manufacturing support, cell culture, purification, process characterization, or technology transfer
- Understanding of regulated manufacturing environments, cGMPs, quality systems, and regulatory expectations
- Experience supporting deviation investigations, troubleshooting, root cause analysis, and corrective action implementation
- Strong technical skills including data analysis, experimental execution, data interpretation, basic statistics, problem solving
Desired Qualifications
- Experience in biopharmaceutical process development
- Drug Substance manufacturing support
- cell culture
- purification
- process characterization
- technology transfer
- deviation investigations
- root cause analysis
- corrective action implementation
- data-driven decision-making
- statistical analysis or data visualization tools
- fluent in English and Spanish
- strong technical writing and presentation skills
- cross-functional collaboration
- cGMP knowledge
- regulatory expectations
- ability to manage priorities and meet timelines
- flexibility to support non-standard shifts or manufacturing operations
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