The Process Development & Validation Scientist is responsible for designing, executing, and interpreting scientific studies that support process development, manufacturing operations, and continuous improvement initiatives within a regulated environment. This role applies scientific expertise to process optimization, process validation, troubleshooting, and data analysis while collaborating with cross-functional teams to ensure robust manufacturing processes, product quality, and regulatory compliance. The Process Development & Validation Scientist supports technology transfer, process characterization, validation activities, and commercial manufacturing by developing innovative scientific solutions and driving process improvements. **Key Responsibilities** - Design, execute, monitor, and interpret scientific studies that support process development and manufacturing operations. - Develop experimental strategies that generate robust, reliable, and reproducible data. - Evaluate scientific results and provide technical recommendations based on data analysis. - Support process characterization, optimization, scale-up, and technology transfer activities. - Develop and implement new methodologies, protocols, and scientific approaches to improve manufacturing processes. - Stay current with scientific literature, industry trends, and emerging technologies relevant to process development. - Provide scientific support for commercial drug product manufacturing operations. - Support process validation activities, including protocol development, execution, data analysis, and final reporting. - Collaborate with Manufacturing, Quality, Engineering, Validation, and Process Development teams to resolve technical issues. - Monitor process performance through data analysis and identify opportunities for continuous improvement. - Provide technical support during manufacturing campaigns and process implementation activities. - Support deviations, investigations, root cause analyses, and product impact assessments. - Ensure scientific studies and validation activities comply with GMP requirements and applicable regulatory guidelines. - Prepare scientific reports, technical protocols, validation documentation, and regulatory support documents. - Participate in inspection readiness activities and provide technical support during regulatory audits. - Analyze scientific and manufacturing data to identify trends and improve process performance. - Interpret experimental results and communicate findings to project teams and leadership. - Author technical protocols, validation documents, scientific reports, presentations, and summary documents. - Maintain accurate, complete, and compliant scientific documentation. - Participate in multidisciplinary teams supporting process development, manufacturing, technology transfer, and validation initiatives. - Collaborate with internal stakeholders to achieve project objectives and meet project timelines. - Provide technical guidance and mentorship to junior team members as appropriate. - Support departmental initiatives related to safety, continuous improvement, and operational excellence. **Skills** - Strong understanding of process development principles and experimental design. - Advanced laboratory, analytical, and scientific troubleshooting skills. - Knowledge of GMP regulations and regulated manufacturing environments. - Strong technical writing and documentation skills. - Excellent analytical, critical thinking, and problem-solving abilities. - Effective verbal and written communication skills. - Strong organizational and project management skills. - Ability to manage multiple priorities in a fast-paced environment. - Proficiency with Microsoft Office applications (Word, Excel, and PowerPoint). - Ability to collaborate effectively with cross-functional teams and adapt to changing priorities. **Qualifications** - Doctorate degree, **OR** - Master's degree with **2+ years** of scientific experience, **OR** - Bachelor's degree with **4+ years** of scientific experience. **Preferred Qualifications** - Experience supporting drug product manufacturing in a regulated environment. - Experience with process validation, including protocol development, execution, and report generation. - Experience authoring technical protocols, validation documents, and scientific reports. - Knowledge of process characterization, technology transfer, and manufacturing support. - Strong understanding of GMP regulations and pharmaceutical manufacturing processes. - Bilingual proficiency in English and Spanish is preferred. - 6-month contract with possible extension - Administrative Shift