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Senior Molecular Biochemist

2 months ago

Athens, Georgia, United States Ortho Clinical Diagnostics Full time

The Opportunity

Ortho Clinical Diagnostics is a leading entity in the field of in vitro diagnostics, merging the expertise of Quidel Corporation and Ortho Clinical Diagnostics. Our organization excels in immunoassay and molecular testing, clinical chemistry, and transfusion medicine, with a workforce exceeding 6,000 professionals operating in over 130 countries. We are dedicated to delivering rapid, precise, and reliable testing solutions across various settings, from home to hospital and laboratory to clinic.

Our organizational culture emphasizes the well-being of our team members, fostering an environment that prioritizes happiness, inspiration, and engagement. We believe that a satisfied workforce is crucial to achieving business success. Our mission is to harness the power of diagnostics to contribute to a healthier future for everyone.

The Role

This position operates with minimal supervision and encompasses a range of production and non-production responsibilities to support manufacturing objectives, ensuring product quality through rigorous testing and observation. The role also involves the operation of moderately complex semi-automated machinery.

Key Responsibilities

Monitor product quality throughout all manufacturing processes, remaining vigilant to identify issues or potential concerns with equipment or products. Conduct in-process testing, chemistry releases, calibrations, and experimental evaluations, while promptly notifying relevant personnel of findings and completing necessary documentation. Organize and oversee biochemistry production and testing schedules. Facilitate training and maintain documentation for all personnel in Molecular Biochemistry. Ensure the accuracy and completeness of manufacturing documentation. Gather and compile data related to all device testing, alerting appropriate personnel if results deviate from compliance standards. Safely operate laboratory equipment in accordance with established protocols. Supervise daily laboratory operations and ensure the completion of instrument logs. Maintain accurate inventory of all testing-related materials. Oversee equipment maintenance and liaise with external vendors for service requests or equipment malfunction reports. Coordinate complaint investigations in collaboration with the testing team. Complete Non-Conformance Material Reports (NCMRs) and other quality documentation. Manage the Pre-delivery Sample testing program. Perform duties in alignment with established business policies. Undertake additional responsibilities and projects as assigned.

The Individual

Required:

A Bachelor’s degree in a scientific discipline or an equivalent combination of relevant experience and education. A minimum of three to five years of related experience. Proven expertise in all relevant Production and Quality Biochemist competencies. Proficient in Microsoft Office Suite, particularly Excel. Excellent communication abilities. Familiarity with aseptic techniques and Biological Safety protocols. Capability to read, interpret, and adhere to detailed procedures, instructions, and schematics. Strong chemistry and laboratory skills, with experience in GLP/GMP environments. Demonstrated ability to work collaboratively and exhibit professional behavior. Strong written and verbal communication skills. Understanding of traceability in product, material, and calibration contexts. Commitment to the development, implementation, and effectiveness of the Quality Management System in compliance with ISO, FDA, and other regulatory standards. Awareness of the quality implications that may arise from improper job performance, including potential device defects related to product design, verification, validation, manufacturing, and testing activities.

Preferred:

A Master’s degree. Two years of relevant experience in a leadership role. Experience with ten-key adding machines is preferred.

Key Working Relationships

Internal Partners:

Collaborate with Quality Control Chemists/Supervisors, Manufacturing, Materials & Warehousing, R&D, Quality Engineering, IT, and Facilities.

External Partners:

Engage with vendors.

Work Environment

The characteristics of the work environment are representative of an office, laboratory, and manufacturing setting, involving the handling of viral and bacterial hazards, potentially hazardous chemicals, and infectious bodily fluids, tissues, and samples. Flexibility in work hours is necessary to meet project deadlines. The position requires the ability to lift up to 20 lbs regularly, with up to 90% of the time spent at a lab bench or desk, involving walking, standing, and sitting for extended periods. Specific vision capabilities required include close and distance vision and the ability to adjust focus. The ability to operate laboratory equipment is essential, and the use of Personal Protective Equipment is mandatory as specified.

Equal Employment Opportunity

Ortho Clinical Diagnostics is committed to providing Equal Opportunity for all individuals and ensuring that all candidates, including those with disabilities, have the opportunity to apply for positions they are qualified for, without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. We are also dedicated to providing reasonable accommodations to qualified individuals to facilitate their job performance.

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