Lead Investigator

What You Will Achieve

In this role, you will:

• Lead or co-lead moderately complex projects, effectively managing time and resources.
• Apply skills and knowledge to contribute to departmental work and resolve moderately complex problems.
• Make decisions guided by policies in non-standard situations and operate independently in ambiguous scenarios.
• Work independently on assignments, seek guidance on complex issues, and review your own and others' work.
• Utilize judgment and experience to become a resource for others and mentor colleagues.
• Troubleshoot and resolve on-site issues, collaborating with site operations to ensure continuous audit readiness.
• Identify high-risk areas, implement improvements, and interface with engineering and technical operations to enhance processes.
• Manage changes in the area, guide operational teams, prepare resource forecasts, and identify improvement opportunities.
• Facilitate agreements between teams, lead clinical production efforts, and ensure timely, injury-free, and defect-free execution.
• Develop Operations Specialists' skills, review area Change Controls, strengthen compliance culture, and enforce safety regulations while sustaining lean management practices.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
• Demonstrated expertise in applying statistical methodologies to enhance manufacturing processes and quality control test methods
• Proficiency in the MS Office Suite, including Word, Excel, PowerPoint, SharePoint, and Visio
• Exceptional verbal and written communication skills
• Strong presentation abilities

Bonus Points If You Have (Preferred Requirements)

• Experience in a GMP environment
• Previous management experience
• Strong problem-solving skills
• Ability to work collaboratively in a team environment
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use