Production Scientist

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Production Scientist is familiar and competent to perform all manufacture, qualification testing and manufacturing release testing for all product types within department. The Production Scientist transfers new product development from multiple company sources for their department and area of responsibility. The position is also accountable for the technical training, maintenance, product improvement projects, customer and internal investigations for those products.

This role is located in Athens, Ohio.

• Identifies and resolves assay performance issues by developing scientific plans and approaches and designing experiments to develop and optimize assays. Summarizes experimental data and draws conclusions independently. Communicating conclusions, improvements and corrections with Department Management.

• Reviews relevant literature and employs creative thinking and application to problem solving. Investigates the feasibility of applying a wide variety of scientific concepts to potential products and implements new methods or procedures.

• Plans and executes experiments and validation of protocols while maintaining detailed and organized project documentation in accordance with internal and external regulatory requirements as part of the design control process. Responsible for determination of feasibility, process development, validation, creation and implementation of documentation.

• Reads, understands and follows cGMP, QSOPs and SOP documentation. Understands each department's product lines and their production processes and performs job duties in accordance with required documentation while completing procedures and records in a timely and accurately fashion.

• Works with minimal supervision and resolves problems independently or collaboratively in a timely manner in order to minimize disruptions in production schedule or product development transfer. Maintains work flow with efficient use of equipment and material resources to maintain production and transfer schedules. Collaborates with other Production Scientist, Department Management and Research Department on the direction and expenditure of employee and equipment resources within departments.

• Serves as a resource for Manufacturing Associates and Technicians for issues and training. Ensures that any staff participating in the manufacture or testing of department's product lines are trained and performing the tasks according to the required documentation.

• Operates all lab equipment with understanding of proper operation, preventative maintenance and safety considerations of the required equipment. Maintains manufacturing areas in accordance with QSOP and safety documentation.

Required:

• Bachelor's or Master's degree in life sciences or equivalent, 4+ years practical experience, and demonstrated working knowledge of research & production methods.

• Associates Degree in life sciences or equivalent, 6+ years practical experience, and demonstrated working knowledge of research & production methods.

• 10 years practical experience, and demonstrated working knowledge of research and/or production methods

• Problem solving and troubleshooting skills

• Effective communication skills required including ability to work with multiple people

• Computer skills in Microsoft Word, Excel or similar programs

• Good laboratory skills including maintaining orderly and safe work areas

• This position is not currently eligible for visa sponsorship.

Preferred:

• Familiarity with cGMPs and FDA guidelines for biological industries preferred.

Internal Partners:

Interacts with all levels of Operations' employees, participates in cross-functional teams and supports interdepartmental project teams. Trains staff and works with Management on troubleshooting and corrective actions.

The work environment characteristics are representative of both an office and laboratory environment.

Handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples. Position requires ability to lift up to 20 lbs. on a regular basis. Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify 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. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

#LI-HF1