Senior Scientist, Quality

POSITION SUMMARY

A Senior Quality Scientist is responsible for independently managing testing priorities, design of experiments for troubleshooting and trending product performance, technical transfer, mentoring and training analysts and associate scientists on trouble shooting techniques and experimental design, advanced troubleshooting of protein-based immunoassays, and approving disposition status for materials under investigation. This may include responsibilities for product release. The incumbent is expected to display a wide-degree of latitude, creativity, and self-management and to be able to independently manage multiple projects in addition to providing oversight and guidance to other team members as needed.

DUTIES AND RESPONSIBILITIES:

• Manage the process of troubleshooting non-conforming products and/or independently manage multiple high-impact projects to improve product and process quality. • Direct testing, analyze data, review and approve results and conclusions of others in the group. • Approve CAPA documents, such as NCMRs and DEVs. • Approve results and conclusions from MRB meetings. • Review and approve presentations of junior level associate scientists and analysts in the group. • Plan testing, analyze data and present that data clearly. • Review corresponding documentation for completion including data capture, forms, logbooks, and/or batch records. • Ensure documentation is in compliance with applicable ISO standards. • Create, coordinate and/or be the Technical Lead of any CAPA documents, such as NCMRs and DEVs. • Coordinate and lead MRB meetings. • Ensure proper handling, quarantine and disposition of discrepant material. • Present to cross-functional and/or senior management teams. • Prepare performance summaries and present results to colleagues. • May manage, coach and develop team members while motivating them to meet and exceed goals. Promote a culture of high performance and continuous improvement that values learning and a commitment to quality. • Participate in general lab organization. • Support 5S compliance. • Develop, revise, approve and implement SOPs/ Test Records/ and product specification documents. • Specific duties may vary depending upon departmental requirements.

EXPERIENCE AND QUALIFICATIONS

• Bachelor's degree in life sciences, protein sciences, cellular/molecular biology, chemistry, biochemistry, biotechnology, or other related area is required. • PhD is preferred • Minimum of 6 years of experience in reagent, product or assay development in an industrial setting is preferred. • Training and experience with Biosafety Level 2 (BSL-2) techniques is highly preferred. • Experience with quality document systems in an ISO/GMP regulated environment preferred. • Must have proven leadership of small teams coupled with an effective management style, as well as proven success at motivating personnel in a fast paced, priority driven environment. • KNOWLEDGE, SKILLS AND ABILITIES • Demonstrated aptitude for learning and applying new techniques and methods • Understand laboratory safety precautions and proper use of personal protective equipment. • Strong leadership skills with demonstrated knowledge and understanding of staff management practices and processes and the ability to establish accountabilities and expectations and manage performance to achieve results. • Experience with protein based immunoassays execution, development, and optimization • Understanding of basic molecular biology techniques • Logical problem solving and the ability to manage complex projects and meet timely deadlines • Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of laboratory data • Effectively communicate performance goals and expectations • Provide coaching and facilitate problem solving methodologies to team • Proficiency in MS Office suite • Experience with standard data analysis tools and databases (Excel, Access, SharePoint) • The ability to multi-task and work productively in a demanding environment with changing priorities • Effectively contributes to the success of departmental and team objectives - works well with personnel at all levels