Process Development & Validation Scientist

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.

Requirements

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.

Benefits

• 6-month contract with possible extension
• Administrative Shift