Research Associate III - Assay Transfer

Job Title:

Research Associate III – Assay Transfer Job Description

The Research Associate III – Assay Transfer plays a key role in bridging product development and manufacturing by leading complex laboratory work that supports the successful transfer and scale-up of reagent products. This role focuses on process characterization, assay transfer, and continuous improvement within a regulated environment, using advanced wet lab and biological techniques to ensure products are manufacturable, robust, and aligned with quality standards.

• Facilitate the transition of products from Development to Manufacturing as an integral member of the Assay Transfer team.
• Initiate, direct, and execute process characterizations, scientific research, and manufacturing process strategies to support new and existing reagent products.
• Investigate the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products, and problems to ensure manufacturability and improve processes, applying aspects of Design for Six Sigma and Design for Quality and Manufacturability (DQM).
• Plan and execute laboratory research related to process characterization, scale‑up activities, and improving process capability for reagent products.
• Maintain broad knowledge of state‑of‑the‑art principles, theories, and experimental approaches relevant to biological assays and manufacturing processes.
• Prepare manufacturing documentation and complete transfer activities for new products, ensuring clarity, accuracy, and compliance with internal standards.
• Use professional scientific concepts to contribute to the development of product and process principles and to achieve project objectives in creative and effective ways.
• Lead the design, execution, and troubleshooting of complex laboratory protocols and bench experiments with minimal supervision.
• Utilize deep analytical judgment as a subject matter expert to solve complex technical problems, optimize laboratory workflows, and identify opportunities for patents or publications.
• Maintain meticulous experimental records, analyze quantitative data, and generate comprehensive technical reports while championing Quality First Time standards.
• Partner actively across organizational boundaries, participate in cross-functional technical teams, and communicate experimental findings and recommendations clearly to stakeholders.
• Contribute creatively to project planning and strategy, helping to define experimental approaches and timelines for assay transfer and process improvement projects.
• Help implement laboratory improvements, including optimization of procedures, tools, and documentation practices to enhance efficiency and data quality.
• Train and mentor other team members in areas of expertise, including experimental techniques, data analysis methods, and best practices for documentation and quality.
• Search and review scientific literature to gain general and specific information that informs experimental design, troubleshooting, and process optimization.

• Bachelor’s degree in a scientific discipline (such as biological science or related field).
• 4–6 years of post-college experience in a relevant scientific or technical role.
• Hands-on experience with wet lab and biological techniques, including routine and complex assay execution.
• Experience working in a regulated environment, ideally within product development and/or manufacturing operations.
• Demonstrated ability to design, execute, and troubleshoot complex laboratory protocols and bench experiments with minimal supervision.
• Strong analytical judgment and problem-solving skills for addressing complex technical challenges and optimizing workflows.
• Ability to perform process characterization and scale‑up activities for reagent or assay-related products.
• Experience preparing clear and accurate manufacturing documents and technical reports.
• Proficiency in maintaining meticulous laboratory records and analyzing quantitative data.
• Capability to apply scientific principles and concepts to evaluate manufacturability and process improvements.
• Skill in searching and interpreting scientific literature to inform…