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. The position also contributes scientific expertise, authors documentation, and may participate in cross-functional or external scientific collaborations.

KEY RESPONSIBILITIES

• 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.
• Introduce advanced scientific methods and contribute to continuous improvement initiatives.
• Stay current in scientific field, technology developments, and industry trends; communicate relevant updates to the team.
• 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.
• Provide direct technical support for AML-1 automatic packaging equipment and inspection processes.
• Apply advanced engineering and scientific principles to process design, troubleshooting, optimization, and modifications.
• Support operational issues such as root cause investigations, equipment troubleshooting, and process failures.
• 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.

COMPETENCIES & SKILLS

• Advanced scientific analysis, laboratory skills, and troubleshooting abilities.
• Strong understanding of cGMP and regulatory requirements.
• Excellent verbal and written communication skills, including technical writing.
• Strong organizational skills with the ability to multitask and manage shifting priorities.
• Project management abilities (timeline tracking, scheduling, coordination).
• Creative problem-solving and ability to apply scientific theory to practical solutions.
• Proficiency with documentation software: Word, Excel, PowerPoint, PDF tools, Visio, MS Project.
• Ability to motivate or supervise others; strong teamwork and collaboration.
• Fully bilingual: English/Spanish.

Requirements

EDUCATION

• Doctorate, OR
• Master’s + 2 years of scientific experience, OR
• Bachelor’s + 4 years of scientific experience.

PREFERRED QUALIFICATIONS (Stand-Out Candidate Attributes)

• Advanced technical support experience with automatic packaging equipment (AML-1) and associated processes.
• Strong knowledge of vision system technologies and inspection/packaging concepts.
• Understanding of serialization requirements, process flows, layouts, and packaging SOPs.
• Experience in troubleshooting and root cause analysis for inspection and packaging processes.
• Experience implementing process optimization initiatives to reduce operational cost.
• Strong documentation and reporting abilities (protocols, validations, technical reports).
• Risk assessment experience (QRAES).
• Project execution skills, including coordination with multiple stakeholders.
• Ability to work flexible hours (1st, 2nd, or 3rd shift) and extended shifts up to 12 hours.
• Self-driven, schedule-oriented, detail-focused, and able to work with OEMs and cross-functional teams.

Benefits

• Administrative Shift
• 6-month contract