Position Summary
The Lead Technician is responsible for executing production processes for therapeutic oligonucleotides in a cGMP-compliant facility. This role supports the manufacturing of high-quality nucleic acid-based therapeutics through hands-on operation of equipment, adherence to standard operating procedures (SOPs), and meticulous documentation practices. The lead technician works closely with cross-functional teams including Quality Assurance, Process Development, and Manufacturing Sciences and technology to ensure consistent, safe, and efficient production.
To perform this job successfully, an individual must be able to perform each of the following essential functions satisfactorily.
Roles and Responsibilities
- Oligonucleotide Production
- Lead routine and non-routine operations under cGMP conditions: synthesis, cleavage and deprotection, purification, ultrafiltration and diafiltration, lyophilization, and other required chemical reactions.
- Support activities related to production such as lab sanitization, material movement, and safety checks.
- Equipment Operation
- Operate and maintain small and large scale equipment including synthesizers, chromatography systems, and lyophilizes.
- Perform instrument calibrations, preventative maintenance, and validations.
- Oversee equipment readiness in alignment with scheduled production.
- cGMP Compliance
- Demonstrate GDP in production records, logbooks, and other required documents.
- Oversee team compliance with internal standard operating procedures to ensure regulatory adherence to cGMP requirements.
- Lead Quality investigations, CAPA implementations, and audit readiness.
- Continuous Improvement
- Lead in troubleshooting activities related to production.
- Identify and execute improvement initiatives.
- Provide feedback and review of systems related to operations.
- Train and mentor new team members.
- Cross-Functional Collaboration
- Represent manufacturing in large and complex multi-department projects.
SHIFT HOURS: Monday to Thursday, 05:30 am to 4:00 pm