Next Generation Sequencing (NGS) Production Scientist

Next Generation Sequencing (NGS) Production Scientist Overview At QIAGEN, we are driven by a simple but powerful vision: making improvements in life possible. We're dedicated to revolutionizing science and healthcare for the better. From our entrepreneurial roots to our current global presence, we've grown into a force for positive change. With thousands of employees across six continents, collaboration is our greatest strength. We're always striving to identify talented individuals to join our exceptional teams.

We have played a pivotal role in shaping modern science and healthcare, and we're just getting started. If you're someone who thrives on new challenges, values diversity and wants to make a tangible difference in people's lives, then QIAGEN is the place for you. At QIAGEN, every day is an opportunity to make a real-life impact. Join us, grow with us, and together, let's shape the future of biological discovery. About the opportunity In this role, you oversee daily production activities for Next Generation Sequencing (NGS) diagnostic kits and molecular diagnostics in a GMPcompliant environment. You drive the preparation and assembly of highquality reagents and kits, analyze and optimize work processes, and make sure production timelines and regulatory requirements are consistently met. You collaborate closely with crossfunctional teams across our Germantown and Frederick sites to support new product introductions and continuous process improvements. Your tasks include 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 costreduction and processefficiency initiatives. Ensure ongoing compliance with applicable quality and EHS regulations and standards (e.g., QSR, ISO, OSHA, IVDD, MDD, FDA, EUPSHA) 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). Your profile 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 handson background in GMP/ISOregulated 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 processefficiency or costreduction improvements. Solid understanding of QSR, ISO, OSHA, IVDD, MDD and related regulatory frameworks, paired with excellent mathematical capabilities and comfort ...For full information see follow application link. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.