Senior Supervisor, In Vitro Diagnostics (Biologics) Product and Process Support at Ortho-Clinical Diagnostics in Raritan, NJ

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As we continue to grow, we are seeking a Staff Scientist to supervise the Product Support group, including workflow analysis and prioritization. The successful candidate will be an integral part of the Operations department and collaborate with Manufacturing, Quality, Regulatory, and R&D teams in support of in-vitro diagnostics (biologics) products.

The successful candidate will actively foster a climate of open communication, engagement and ownership within the team, and build highly effective cross-functional working relationships. The successful candidate will partner with management through change and transformation activities and support technical initiatives in alignment with site's goals.

This position is located in Raritan, NJ.

The Responsibilities

• Supervise scientists working in the Product Support group.
• Facilitate resolution of technical issues and provide direction regarding prioritization of work.
• Create goals and objectives and development plans for direct reports. Monitor performance and deliver feedback.
• Partner with cross functional teams as technical support for projects (technology transfer, process improvement, supplier changes, equipment obsolescence, etc.). Provide appropriate resources and oversee direct reports that are developing overall validation strategy, leading risk assessments, developing and validating test methods, conducting equipment validation/process qualification, and authoring associated validation documents.
• Help manage support of root cause investigations as a result of product failure, along with non-conformances that may result in manufacturing, to ensure product release timelines are met.
• Ensure adherence to cGMP requirements and company safety policies. Proactively maintain a clean and safe work environment.

The Individual

• Bachelor’s Degree in lab sciences such as Biochemistry, Molecular Biology, Immunology, Chemistry, Medical Technology, or related sciences field
• Minimum 7 years of experience with Bachelor’s or 5 years of experience with Master’s, with experience associated with operations and manufacturing
• Previous experience supervising associates and/or leading teams is required
• Excellent written and verbal communication skills with proficiency in Microsoft Office (Word, Excel, PowerPoint, etc.) is required
• Knowledge of safe chemical and biological handling is required
• Strong prioritization and multitasking skills, as well as managing one's own time is required.
• Previous experience in cGMP processes associated with reagent/biologics formulation is preferred
• Experience with Minitab and other statistical software is preferred