Next Generation Sequencing (NGS) Production Scientist

QIAGEN•Frederick, CO

2d•$80,000 - $97,000•Hybrid

About The Position

In this role, you oversee daily production activities for Next Generation Sequencing (NGS) diagnostic kits and molecular diagnostics in a GMP‑compliant environment. You drive the preparation and assembly of high‑quality reagents and kits, analyze and optimize work processes, and make sure production timelines and regulatory requirements are consistently met. You collaborate closely with cross‑functional teams across our Germantown and Frederick sites to support new product introductions and continuous process improvements.

Requirements

A BS/BA degree in a scientific or engineering discipline with 8–10 years of relevant manufacturing experience, or an MS with 4–6 years of experience in manufacturing operations.
Strong hands‑on background in GMP/ISO‑regulated biotechnology or diagnostics manufacturing, including work with magnetic beads (suspension material), oligo quantification, and library preparation.
Proven experience with validations, batch record review, investigation of product/process/equipment nonconformities, and implementation of process‑efficiency or cost‑reduction improvements.
Solid understanding of QSR, ISO, OSHA, IVDD, MDD and related regulatory frameworks, paired with excellent mathematical capabilities and comfort working with metric volumes.
Demonstrated leadership and organizational skills, with the ability to guide laboratory personnel, coordinate workload, and maintain high operational standards in a dynamic environment.
Strong communication skills in spoken and written English, coupled with the ability to maintain professionalism while shifting priorities quickly.
Occasional travel required between the Germantown and Frederick sites.

Nice To Haves

Proficiency in Microsoft Office; familiarity with Lean management principles and SAP (especially SAP PP or manufacturing‑related modules) considered an advantage.

Responsibilities

Oversee and perform the preparation of buffers, oligonucleotide libraries, enzyme mixes, and complete kit components for NGS products.
Assemble NGS diagnostic kits according to production schedules, ensuring accurate and complete batch documentation in compliance with GMP and relevant regulations.
Ensure that laboratories are maintained in accordance with GMP/ISO and EHS requirements and that production schedules are met on time with consistently high quality.
Analyze work processes and support efficient utilization of staff, laboratory space, and equipment; assist in capacity planning to meet production forecasts and train laboratory personnel on safe, efficient, and compliant operations.
Review and correct batch records, manage investigations of product, process, and equipment nonconformities, and assist with validations as well as cost‑reduction and process‑efficiency initiatives.
Ensure ongoing compliance with applicable quality and EHS regulations and standards (e.g., QSR, ISO, OSHA, IVDD, MDD, FDA, EU‑PSHA) while contributing to department and corporate goals and performance metrics.
Facilitate the transfer and implementation of new products into operations, coordinating technology and product transfers between development and manufacturing sites, preparing master data and change processes, and supporting more efficient processes for defined product families (including the use of systems such as SAP).