Position Summary
The Molecular Manufacturing Technologist performs high complexity molecular techniques including cell culture, control and reagent manufacturing, nucleic acid extractions, and next generation sequencing (NGS). Works independently with minimal supervision, provides technical expertise in assigned workflows, and contributes to document revision and process improvements.
Job Responsibilities
- Follow laboratory SOPs and established protocols.
- Perform molecular techniques: cell culture, control/reagent manufacturing, nucleic acid extraction, quantification/normalization, NGS, and other assignments.
- Maintain quality standards; troubleshoot instruments and perform routine maintenance.
- Assist in training/mentorship of technologists.
- Prepare CAPA/QE/DEV documentation for nonconformance events.
- Collaborate with Quality, Product Development, Translational Science, and Regulatory to validate/implement new technologies, methods, and equipment.
- Use LIMS to record and track day-to-day tasks.
- Represent the department in audits/investigations and cross-functional initiatives.
- Identify continuous improvement opportunities; initiate/track continuing education.
- Follow specimen/material/reagent handling and quality control policies (FDA, CAP, CLIA, NYS, ISO).
- Address out-of-range test system performance and document corrective actions.
- Perform high complexity testing under onsite general supervisor supervision (CLIA).
Required Qualifications
- Bachelorโs degree in chemical, biological, clinical/medical laboratory science, or medical technology (accredited).
- 3+ years molecular and/or manufacturing experience; at least 1 year high complexity testing.
- Mastery of molecular assay operations and QC systems.
- Experience in FDA regulated industries.
- Proficient in Microsoft Office (Word, Excel, Outlook) and able to use office equipment.
Preferred Qualifications
- Masterโs degree.
- ISO 13485 regulated industry experience.
- High autonomy; strong analytical judgment; proactive, collaborative approach.
- Biohazard/chemical safety and quality control/regulatory mastery.
- Fast-paced, deadline-driven capability; strong verbal/written communication.
Required Training
- Job-specific safety and compliance training as assigned.
Other
- May require evenings/nights, weekends, and holidays.