Senior Molecular Biochemist

Opportunity Overview

Ortho Clinical Diagnostics is a premier entity in the in vitro diagnostics sector, merging the expertise of Quidel Corporation and Ortho Clinical Diagnostics. We are dedicated to delivering rapid, precise, and reliable testing solutions across more than 130 countries, enhancing health outcomes from home to hospital.

Our organizational culture emphasizes the well-being of our employees, fostering an environment that encourages inspiration, engagement, and satisfaction. We believe that a happy workforce is essential for achieving business excellence.

Position Summary

This role operates with minimal oversight, encompassing a range of production and non-production tasks that support our manufacturing objectives while ensuring product quality through rigorous testing and observation. The position involves the operation of moderately complex semi-automated systems.

Key Responsibilities

• Vigilantly monitor product quality during all manufacturing processes, identifying and addressing any equipment or product issues promptly.
• Execute in-process testing, chemistry releases, calibrations, and experimental assessments, ensuring timely communication of results and completion of all relevant documentation.
• Schedule and oversee biochemistry production and testing operations.
• Facilitate training and maintain training records for all personnel involved in Molecular Biochemistry.
• Ensure the accuracy and completeness of all manufacturing documentation.
• Compile and analyze data related to device testing, alerting relevant personnel of any compliance issues.
• Safely operate laboratory equipment according to established protocols.
• Supervise daily laboratory operations and maintain instrument logs.
• Ensure accurate inventory management of all testing materials.
• Manage equipment maintenance and liaise with external vendors for service requests.
• Coordinate complaint investigations in collaboration with the testing team.
• Complete Non-Conformance Material Reports (NCMRs) and other quality documentation as required.
• Oversee the Pre-delivery Sample testing program.
• Adhere to established business policies while performing other assigned duties and projects.

Candidate Profile

Required Qualifications:

• Bachelor's degree in a scientific discipline or an equivalent combination of education and relevant experience.
• A minimum of three to five years of pertinent experience.
• Proven expertise in Production and Quality Biochemistry.
• Proficient in Microsoft Office Suite, particularly Excel.
• Excellent communication skills.
• Familiarity with aseptic techniques and Biological Safety practices.
• Ability to interpret and follow detailed procedures and instructions.
• Strong chemistry and laboratory skills, with experience in GLP/GMP environments.
• Demonstrated ability to work collaboratively and professionally within a team.
• Strong written and verbal communication capabilities.
• Understanding of traceability for products, materials, and calibrations.
• Commitment to the development and effectiveness of the Quality Management System in compliance with ISO, FDA, and other regulatory standards.
• Awareness of potential quality issues arising from improper job performance, including product design and testing activities.

Preferred Qualifications:

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

Collaborative Relationships

Internal Collaborators:

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

External Collaborators:

Vendors.

Work Environment

The work environment includes elements typical of an office, laboratory, and manufacturing setting, involving exposure to viral and bacterial hazards, hazardous chemicals, and potentially infectious materials. Flexibility in work hours may be necessary to meet project demands. The role requires the ability to lift up to 20 lbs regularly, with up to 90% of time spent at a lab bench or desk, including walking, standing, and sitting for extended periods. Specific vision capabilities required include close and distance vision, with the ability to adjust focus. Personal Protective Equipment (PPE) must be utilized as per established guidelines.

Equal Employment Opportunity Statement

Ortho Clinical Diagnostics is committed to providing equal employment opportunities for all individuals, including those with disabilities. We strive to ensure that all qualified candidates have the opportunity to apply for positions without discrimination based on race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic.

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