Senior Technical Associate, Production NGS

About The Opportunity

The Senior Technical Associate, Production NGS is responsible for performing routine manufacturing activities associated with the Next Generation Sequencing (NGS) diagnostic kits and Molecular diagnostics products in a GMP compliant environment. The individual will execute production processes, maintain accurate documentation, perform troubleshooting with appropriate support, and operate, and maintain laboratory equipment to ensure the consistent production of high-quality products. The position also supports continuous improvement initiatives, investigations, and the implementation of new products and processes.

Responsibilities

• Prepare buffers, oligonucleotide libraries, enzyme mixes, and complete kit components for NGS products according to production schedules, ensuring accurate batch record and compliance with applicable regulatory requirements.
• Execute batch records and accurately complete all production related documentation in a timely manner.
• Operate, maintain and calibrate standard laboratory equipment to support production activities.
• Initiate and support investigations of product, process, equipment nonconformities, and assist with corrective actions as needed.
• Ensuring ongoing compliance to applicable quality, regulatory and EHS requirements, including ISO, FDA, MDD, IVDD, OSHA.
• Contribute and support departmental and corporate goals.
• Contribute to new product implementation.

Requirements

• Bachelor’s degree in a scientific or engineering discipline with 1-3 years of relevant experience in manufacturing environment.
• Previous experience working in a GMP and/or ISO-regulated manufacturing environment is highly preferred.
• Hands-on experience with magnetic beads (suspension material), and oligonucleotide quantification is preferred.
• Knowledge of current QSR, ISO, OSHA, IVDD, MDD regulations are desirable.
• Basic mathematical skills, including the ability to accurately perform calculations and work with metric units, volumes and measurements.
• Able to thrive in a fast-paced manufacturing environment, effectively managing changing priorities and multi-task while maintaining a professional demeanor.
• Able to work safely and effectively in a team environment.
• Strong organization skills with exceptional attention to detail and accuracy.

Qualifications

• Minimum travel between the Germantown and Frederick sites may be required.

Skills

• Basic understanding of QSR, ISO, OSHA, IVDD, MDD regulations.
• Hands-on experience with magnetic beads and oligonucleotide quantification.
• Ability to work independently and manage multiple tasks.
• Attention to detail and accuracy in documentation.

Benefits

The estimated base salary range for this position is $50,000-$60,000. Compensation will be based on the candidate’s experience, skills, geographic location, and other job-related factors. In addition to base salary, we offer a total compensation package that includes a commission plan, annual bonus, and generous benefits.