Process Development Scientist - Manufacturing

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