PCR Assay Scientist

About the position

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package. Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. If you’re looking for a rewarding career, a place to call home, apply with us today!

Responsibilities

• Perform testing in support of product manufacturing, employing manual and automated analytical equipment.
• Provide direct support of Quality Control analytical processes, test procedures, qualifications, validations, assay troubleshooting, equipment upkeep, logbook review, and inventory control.
• Execute Analytical Test Methods for bulk intermediate (drug substance), final drug product, and raw materials release/stability testing.
• Conduct DNA extraction and qPCR testing to support Vector Copy Number (VCN) and Vesicular Stomatitis Virus G glycoprotein (VSVG) assays.
• Coordinate, schedule, and execute testing based on manufacturing schedules.
• Participate in the review process of SOPs and analytical test procedures as necessary to maintain compliance.
• Review Quality Control raw data for accuracy, completeness and compliance with effective SOPs.
• Troubleshoot and analyze nonconforming data.
• Perform timely response to Out of Specification (OOS) results, including notification to area management.
• Perform and document laboratory investigations to ensure that potential problems and root causes are identified.
• Ensure data integrity is maintained for all applications, programs, and executed work.
• Maintain laboratory housekeeping including organization, cleanliness, and logbooks.
• Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain compliance.
• Author and/or execute protocols and generate technical reports.
• Author and manage change controls.
• Perform equipment standardizations and qualification, as necessary.
• Perform training of other employees.
• Communicate with the individual Operations Departments (Manufacturing, Quality).

Requirements

• BS in biochemistry, chemistry, or similar scientific discipline.
• 2+ Years of quality control experience in a GMP environment specifically working on qPCR methodology in a similar role in the biologics industry.
• Experience with DNA Extraction techniques.
• 2+ Years of mammalian cell culture in an academic or industrial laboratory.
• Knowledge of basic laboratory skills (including aseptic technique, pipetting, biohazard control).
• At least 1 year of GMP/GDP experience.
• Familiarity with analytical equipment such as UV absorbance plate readers, Flow cytometers, microscopes, and pH meters is recommended.
• Excellent verbal and written skills with good interpersonal communication skills.
• Must be open to occasional off shift and weekend work.
• Must be eligible to work in the United States indefinitely without sponsorship.

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.
• Yearly goal-based bonus & eligibility for merit-based increases.