Sr. Scientist

About the role

As a Senior Scientist you will support assay development through commercial application of new and innovative service offerings within the analytical and bioassay testing space. You will ensure scientific integrity of technical work, maintain detailed documentation, and uphold professional/industry standards. The role provides holistic scientific oversight of a specific discipline or laboratory, may include supervisory/Team Lead responsibilities, Study Management, and Study Director duties for GLP studies, including safety testing for clinical and commercial products, assay/process improvements, and compliance with cGMP and GLP.

Responsibilities

• Oversee the daily management of a team developing new assays and conducting a wide variety of assays or tests required to characterize product or material safety.
• Liaise closely with client representatives to ensure their expectations are met or exceeded. This should include input into technical design of new custom assays and ongoing scientific support throughout these projects / programs.
• Provide regular updates of technical developments, new assays, innovation within the industry to Operations teams, Support teams (as relevant), and other members of the Technical Support group.
• Promote a culture of continuous improvement within Contract Testing Service; act as champion on initiatives and/or projects to drive improvement in quality and / or client service.
• Prepare and present (internally and externally) scientific data, abstracts, papers, posters, etc. to advance the reputation of BioReliance within the marketplace.
• Responsible for assay / method / process validation ensuring assays / methods / processes are maintained in a validated state within area of expertise.
• Track and trend key assay / production parameters and recommend courses of action to address any adverse trends and / or issues that arise.
• May serve as study director and ensures timely initiation and completion of all studies. Ensures testing is performed in accordance with SOPs and regulations (cGMP and GLP) for custom/non routine and new services.
• Participate and/or drive assay development/ assay transfer and/or assay validation activities.
• Drive implementation of new services.
• Participate in critical event / lab investigations within Contract Testing Services and liaise with Program Management to ensure the significance of events is actively communicated to clients.
• Work with operational departments within area of expertise to update assays in line with the appropriate Validation Master Plan and client / regulatory expectations.
• Lead by example, offer scientific coaching and mentoring to other staff members (