Summary: The Process Development Scientist will be responsible for conceiving, designing, implementing, and executing scientific experiments to support the successful completion of organizational goals and projects under general guidance.
This role requires advanced scientific analysis, troubleshooting skills, and hands-on experience in laboratory work, validation, and compliance within highly regulated environments.
The scientist will contribute to the development of new processes, provide technical support, and ensure studies are conducted in adherence to established protocols and guidelines.
Key Responsibilities: Experimental Design and Data Analysis: Independently design, execute, and interpret experimental strategies.
Conduct data analysis, assess impacts on project goals, and contribute insights to new processes.
Author scientific and technical reports, regulatory documents, and patent submissions.
Develop and implement novel protocols and support colleagues with experimental design, data interpretation, and innovative solutions.
Compliance and Validation: Ensure adherence to cGMPs, GLPs, and applicable regulatory guidelines.
Contribute to validation processes, including equipment characterization, testing strategies, and risk assessments.
Support the execution of SATs, document generation, and regulatory submissions for validation activities.
Project Leadership and Collaboration: Actively participate in cross-functional teams and represent the department in project-related discussions.
Initiate and support collaborative efforts, both internal and external, to solve scientific challenges and drive projects forward.
Develop project timelines and manage multiple projects, ensuring timely completion of deliverables.
Documentation and Reporting: Prepare detailed technical reports, scientific summaries, and regulatory submissions.
Present technical findings in a clear, organized manner to both technical and senior management teams.
Engagement and Departmental Support: Participate in departmental initiatives, such as safety and compliance efforts, recruitment, and internal committees.
Engage with external scientific communities and stay current with advances in the field.
Skills: Expertise in scientific theory application and problem-solving for complex technical issues.
Strong leadership and collaboration skills for managing cross-functional projects.
Ability to adapt to change and work effectively in a dynamic environment.
Requirements Education Requirements: Doctorate degree OR Master's degree with 5+ years of scientific experience OR Bachelor's degree with 6+ years of scientific experience.
Preferred Qualifications: Knowledge of pharmaceutical or biotech processes, including validation and documentation in regulated environments.
Expertise in Vision System technologies and inspection/packaging concepts.
Experience in protocol development, validation strategies, risk assessments, and equipment characterization.
Strong verbal and written communication skills, technical writing, and negotiation abilities.
Proficient project management skills, including schedule development and resource allocation.
Demonstrated problem-solving abilities, particularly in scientific and engineering theory.
Ability to manage multiple projects and maintain productive working relationships with cross-functional teams.
Bilingual in English and Spanish.
Proficiency with computer applications (Word, Excel, PowerPoint) in a Windows environment.
Flexibility to work off-hours as needed.
Shift: 8-hour shifts | 8:00 am – 5:00 pm, 5 days a week