Lead Technician, Manufacturing
About The Position
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.
Requirements
- Associate’s or Bachelor’s degree in Biotechnology, Chemistry, or related field – OR – 3 years of experience in a cGMP chemical manufacturing role preferably oligonucleotide related.
- Strong interpersonal and communication skills
- Able to work in a fast paced and dynamic environment
- Detail oriented
- Able to identify, assess, and address problems efficiently
Nice To Haves
- Experience with mid to large laboratory equipment and operations.
- Experience operating within cGMP quality systems
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.
Benefits
- Competitive compensation with strong bonus program
- Comprehensive medical, dental, and vision benefits for employees and dependents
- FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
- Deductible Buffer Insurance and Critical Illness Insurance
- 401(k) retirement plan with matching employer contribution
- Company-paid short- and long- term disability, life insurance, and employee assistance program
- Flexible work options- 8, 10 and 12 hour shifts available with option of day, swing and night shifts.
- Pet Insurance for our furry friends
- Enhanced Parental leave of 8 additional weeks
- PTO that begins immediately
- Full week paid off during the holidays
- Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Companywide social events, frequent catered lunches and much more!
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
11-50 employees
