Process Development Scientist

The Scientist will conceive, design, execute, and interpret scientific experiments that support departmental and project goals. Under general guidance, this role develops robust processes, drives technical investigations, supports packaging/inspection operations, and ensures all activities comply with protocols, cGMP, and regulatory requirements.

Requirements

• Conceive, design, execute, evaluate, and interpret experimental strategies to support process and operational improvements.
• Develop and implement new protocols to address complex scientific or operational issues.
• Provide thorough data analysis, interpretation, and assessment of findings and their project impact.
• Ensure all studies and experiments comply with protocols, guidelines, regulations, and cGMP requirements.
• Independently author scientific reports, summaries, complex regulatory documents, invention disclosures, and patents.
• Support validation, characterization, and qualification activities, including protocol and report preparation.
• Apply advanced engineering and scientific principles to process design, troubleshooting, optimization, and modifications.
• Identify and implement cost-reduction initiatives while maintaining product quality.
• Establish testing strategies for characterization activities.
• Design, develop, and execute characterization protocols.
• Prepare technical reports, validation documentation, and support SAT execution.
• Perform and support risk assessments (including QRAES).
• Coordinate project execution activities: material requests, training, production window planning, and work order generation.
• Represent the department on project teams under senior guidance.
• Initiate and support collaborations inside and outside the department.
• Provide guidance in experimental design, data interpretation, and innovative solutions.
• May supervise or mentor junior staff and support team-wide initiatives such as safety, recruiting, or committees.
• Provide technical training and knowledge transfer to interdisciplinary teams and OEM partners.
• Maintain timelines for project deliverables and ensure effective communication across teams.

Benefits

• Administrative Shift