Sr. Research Associate - Assay Transfer

Sr. Research Associate – Assay Transfer
Employment Type: Contract
Function: Assay Transfer, Process Development & Manufacturing Support
Drive the Successful Transfer of Innovative Diagnostic and Reagent Products
We are seeking a highly motivated Sr. Research Associate – Assay Transfer to support the transition of new and existing reagent products from Development into Manufacturing. In this role, you will play a critical part in ensuring products are successfully scaled, characterized, transferred, and optimized for commercial production.

This position is ideal for a scientific professional with hands-on experience in Immunohistochemistry (IHC), In Situ Hybridization (ISH), assay development, process characterization, and regulated laboratory environments. You will collaborate across R&D, Manufacturing, Quality, and Technical Operations teams to enhance process performance, improve manufacturability, and maintain the highest quality standards.
Key Responsibilities Assay Transfer & Process Development

• Support the transfer of new and existing reagent products from Development to Manufacturing.
• Plan, execute, and troubleshoot process characterization studies and manufacturing readiness activities.
• Develop strategies to improve process capability, manufacturability, and operational efficiency.
• Apply Design for Six Sigma and Design for Quality and Manufacturability (DQM) principles to drive process improvements.

Laboratory Execution & Scientific Investigation

• Lead the design, execution, and troubleshooting of complex laboratory protocols and bench-scale experiments with minimal supervision.
• Conduct process characterization and scale-up activities to support manufacturing implementation.
• Perform laboratory testing, document observations, and execute quantitative data analysis.
• Utilize scientific literature and technical resources to support experimental design and problem-solving efforts.

Manufacturing Transfer & Quality Support

• Prepare manufacturing documentation and support product transfer activities for new product introductions.
• Champion a “Quality First Time” approach and identify opportunities to improve laboratory and manufacturing processes.
• Collaborate with manufacturing teams to ensure successful implementation of transferred processes and products.

Technical Problem Solving & Subject Matter Expertise

• Serve as a technical resource for troubleshooting complex scientific and process-related challenges.
• Investigate root causes, implement corrective actions, and resolve technical issues affecting product performance or manufacturability.
• Identify opportunities for workflow optimization, innovation, and potential intellectual property or publication development.

Documentation, Reporting & Communication

• Generate detailed technical reports, protocols, summaries, and experimental documentation.
• Analyze and present scientific data to project teams, management, and cross-functional stakeholders.
• Maintain accurate records and ensure compliance with established quality and documentation standards.

Collaboration & Leadership

• Partner with cross-functional teams throughout product development, transfer, and manufacturing activities.
• Participate in technical teams, process investigations, and continuous improvement initiatives.
• Contribute to project planning and provide creative scientific solutions to complex challenges.
• Mentor and train team members in areas of technical expertise when needed.

Required Qualifications Education & Experience

• Bachelor’s degree in a scientific discipline with 6+ years of relevant post-college industry experience, OR
• Master’s degree in a scientific discipline with 1+ year of relevant industry experience.

Technical Expertise

• Hands-on laboratory experience with:
  • Immunohistochemistry (IHC)
  • In Situ Hybridization (ISH)
  • Biological and wet-lab techniques
• Experience working in a regulated environment, product development organization, and/or manufacturing operations.
• Proficiency with:
  • Laboratory methodologies and instrumentation
  • Scientific literature research
  • Microsoft Office applications and data analysis tools
  • Spreadsheet, reporting, and presentation software

Professional Skills

• Strong experimental design, data analysis, and troubleshooting capabilities.
• Excellent technical writing and scientific communication skills.
• Demonstrated ability to work independently while collaborating effectively across multiple functions.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.

Candidate Requirements

• Candidates must meet the minimum experience requirements:
  • Bachelor's degree: 6+ years of post-college relevant experience
  • Master's degree: 1+ year of relevant experience
• Ph.D. candidates are not being considered for this opportunity.

Ideal Candidate Profile
The ideal candidate combines strong laboratory expertise with a passion for process improvement, technology transfer, and manufacturing excellence. You thrive in a collaborative scientific environment and enjoy solving complex technical challenges while helping bring innovative products from development into production.

Keywords: Sr. Research Associate, Assay Transfer, Immunohistochemistry, IHC, In Situ Hybridization, ISH, Process Characterization, Reagent Development, Manufacturing Transfer, Product Development, Life Sciences, Biotechnology, Regulated Laboratory, Scientific Research, Design for Six Sigma, Process Improvement, Technical Operations, Laboratory Scientist Jobs.