The Process Development 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, troubleshooting, investigations, and data analysis while collaborating with cross-functional teams to ensure robust manufacturing processes, product quality, and regulatory compliance. **Key Responsibilities** - Design, execute, monitor, and interpret scientific studies to support process development and manufacturing operations. - Develop experimental strategies that generate robust, reliable, and scientifically sound data. - Evaluate scientific results and provide technical recommendations based on data analysis. - Support process characterization, optimization, and technology transfer activities. - Develop and implement new methodologies, protocols, and experimental approaches to improve manufacturing processes and resolve technical challenges. - Stay current with scientific literature, industry trends, and emerging technologies relevant to process development. - Provide scientific support for commercial manufacturing operations, including formulation and aseptic filling processes. - Collaborate with Manufacturing, Quality, Engineering, Validation, and Process Development teams to resolve technical issues. - Support manufacturing floor activities by providing process expertise in a fast-paced production environment. - Monitor process performance through data trending and statistical analysis. - Identify opportunities for process optimization and continuous improvement. - Support deviations, investigations, root cause analyses, and product impact assessments. - Ensure scientific studies and process development activities comply with GMP requirements and applicable regulatory guidelines. - Prepare scientific reports, technical summaries, protocols, validation documentation, and regulatory support documents. - Participate in audit readiness activities and provide technical support during regulatory inspections. - Analyze manufacturing and experimental data using statistical tools to identify trends and improve process performance. - Interpret results and communicate findings to project teams and leadership. - Author technical reports, scientific documentation, protocols, and presentations. - Present scientific findings to cross-functional teams and management. - Participate on multidisciplinary teams supporting process development, technology transfer, manufacturing, and continuous improvement initiatives. - Collaborate with internal and external stakeholders to achieve project objectives. - Mentor junior scientists and provide technical guidance as appropriate. - Support departmental initiatives related to safety, operational excellence, and knowledge sharing. - Manage project timelines and ensure timely completion of assigned deliverables. **Skills** - Strong understanding of process development principles and experimental design. - Knowledge of GMP regulations and regulated manufacturing environments. - Excellent analytical, laboratory, troubleshooting, and problem-solving skills. - Strong statistical analysis and data interpretation capabilities. - Excellent technical writing, documentation, and presentation skills. - Strong verbal and written communication skills. - Effective project management and organizational skills. - Ability to manage multiple priorities in a fast-paced environment. - Proficiency with Microsoft Office applications (Word, Excel, PowerPoint). - Strong collaboration skills and the ability to work effectively across cross-functional teams. **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** - Degree in Life Sciences, Biochemistry, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences, or a related scientific discipline. - Experience supporting process development or commercial biotechnology/pharmaceutical manufacturing. - Understanding of protein science, formulation development, and aseptic manufacturing processes. - Experience with process monitoring, statistical analysis, and data trending. - Experience using statistical software such as **JMP** or similar analytical tools. - Experience supporting deviations, investigations, root cause analysis, and product impact assessments. - Strong technical writing skills with experience preparing scientific, validation, or regulatory documentation. - Bilingual proficiency in English and Spanish. - 6-month contract with possible extension - Administrative Shift