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