Analytical Technology Specialist - Remote Opportunity

About the Role

We are looking for a talented Analytical Technology Specialist to join our team remotely. In this role, you will play a crucial part in supporting the NPI group's activities in release and stability testing for products in development. This is an exciting opportunity to contribute to innovative medicines and solutions that address serious health issues.

What You'll Do

• Support NPI QC Testing on PSBs, Clinical, PPQ, Demo, and investigational lots using Cell Based Potency Assay and ELISA methods.
• Timely review of testing records and all associated documentation.
• Conduct routine laboratory duties such as critical reagent qualifications, inventory management, and equipment maintenance.
• Ensure all activities adhere to regulatory (QA and EHS) and corporate requirements.
• Open and progress QMS records as needed (Laboratory Investigations, Change Controls).
• Complete assigned training in a timely manner.
• Maintain laboratory data integrity by understanding applicable regulations and business processes.
• Provide input on assay performance monitoring and trending.
• Support Root Cause Analysis Investigations.

Requirements

• Bachelor’s, Master’s, or Ph.D. in Biological Science with 1-3 years of QC GMP experience.
• Practical experience in mammalian cell culture and basic techniques (passaging, freeze-down, drug treatments) is an advantage.
• Strong scientific and practical understanding of ELISA-based methods.
• Proven problem-solving skills and clear communication skills.
• Good organizational and interpersonal skills.
• Ability to lead and drive projects to meet timelines.
• Focus on Right First Time (RFT).

Nice to Have

• Experience in a cGMP/GLP environment.
• Familiarity with laboratory data integrity regulations.
• Experience with laboratory investigations and change controls.

What We Offer

• Competitive salary and benefits package.
• Remote work flexibility.
• Opportunity to work with a leading biotechnology company.
• Professional development and training opportunities.
• Collaborative and inclusive company culture.