Process Development Scientist

We are seeking a Process Development Scientist to provide scientific and technical support for commercial biopharmaceutical manufacturing operations. This position will support formulation and aseptic filling processes while collaborating with cross-functional teams to ensure product quality, process reliability, and regulatory compliance. Responsibilities Provide scientific and technical support for commercial formulation and aseptic filling operations. Monitor manufacturing processes and analyze process performance using statistical tools (e.g., JMP). Support deviations, investigations, root cause analysis, and product impact assessments. Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams to resolve technical issues. Prepare technical documentation and reports to support regulatory inspections and compliance activities. Provide manufacturing floor support in a fast-paced production environment. Identify and implement process improvements while ensuring compliance with cGMP requirements. Qualifications Doctorate in a scientific discipline; OR Master's degree with 2+ years of relevant scientific experience; OR Bachelor's degree with 4+ years of relevant scientific experience. Experience in a commercial biopharmaceutical manufacturing environment. Experience supporting formulation and aseptic filling operations. Understanding of protein science, formulation, and aseptic filling processes. Experience with process monitoring, data trending, and statistical analysis software (e.g., JMP). Experience supporting deviations, investigations, root cause analysis, and product impact assessments. Strong technical writing skills and experience preparing documentation for regulatory inspections. Excellent communication, presentation, project management, and problem-solving skills. Ability to work effectively with cross-functional teams. Bilingual proficiency in English and Spanish (written and verbal). Work Schedule Regular schedule is Monday through Friday, 8:00 AM to 5:00 PM. This position supports a 24/7 manufacturing operation, and candidates must be available to work extended shifts (up to 12 hours), nights, weekends, and holidays as business needs require. Job Type: Full-time Pay: $40.00 - $45.00 per hour Education: Bachelor's (Preferred) Experience: statistical analysis software (e.g., JMP): 5 years (Preferred) deviations: 5 years (Preferred) investigations: 5 years (Preferred) root cause analysis: 5 years (Preferred) product impact assessments: 5 years (Preferred) preparing documentation for regulatory inspections: 5 years (Preferred) commercial biopharmaceutical manufacturing environment: 5 years (Preferred) formulation and aseptic filling operations: 5 years (Preferred) protein science: 5 years (Preferred) formulation: 5 years (Preferred) aseptic filling processes: 5 years (Preferred) process monitoring: 5 years (Required) data trending: 5 years (Preferred) Language: English & Spanish (Preferred) Work Location: In person