_{10th June, 2025}

SUMMARY

Under general direction, functions as the technical specialist for testing and development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources.
 
FUNCTIONS:

• Responsible for providing technical guidance, Provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise.
• Resolve technical issues and troubleshoot for assays as necessary
• Ensure lab compliance which includes: Implementing procedures that enhance GMP, GLP and safety.
• Manage existing and/or develop and implement new programs, processes and methodologies.
• Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact.
• Approve lab investigations, Lead audit teams
• May serve as subject matter expert to develop technical training.
• May perform routine work in a specific area of responsibility as necessary.
• Represents the department/organization on various teams, Independently responsible for following through on multi-site action items.
• May interact with regulatory agencies regarding area(s) of responsibility including written responses.
• May resolve issues with outside resources.
• Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.

• Doctorate OR -Masters + 2 years of directly related experience OR -Bachelors + 4 years of directly related experience OR -Associates + 8 years of directly related experience OR -High school/GED + 10 years of directly related experience.
• Educational background in Chemistry, Microbiology, Biology or Life Sciences
• Laboratory experience in a GMP environment within the Pharmaceutical and/or Biotech industry
• Fully bilingual communications skills (English and Spanish)
• Good communications and presentation skills in English and Spanish
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Enhanced skills in leading, influencing and negotiating
• Knowledge of and experience with processes involved in manufacturing and distribution, QA, QC, validation and process development
• Basic Knowledge and skills of word processing, presentations, and spreadsheet applications