SUMMARY
As a member of the Assay Transfer team, you will facilitate the seamless transition of new and existing reagent products from Development to Manufacturing. This role involves initiating, directing, and executing process characterization, scientific research, and manufacturing process strategies to support product manufacturability and improve process capability.
CANDIDATE REQUIREMENTS & QUALIFICATIONS
Education & Experience:
Bachelor's degree in Science with 6+ years of post-college relevant experience, OR
Master's degree with 1+ year of relevant experience.
Technical Expertise:
Hands-on experience with wet lab and biological techniques, specifically IHC (Immunohistochemistry) and ISH (In Situ Hybridization).
Direct experience in a regulated environment, product development, and/or manufacturing operations.
Proficiency in standard laboratory techniques, scientific literature retrieval, and software tools (word processing, spreadsheets, graphical/presentation applications).
Methodologies: Ability to apply Design for Six Sigma and Design for Quality and Manufacturability (DQM) principles to optimize processes and solve potential inventions or production issues.
Candidate Guidelines: Candidates must meet the minimum post-college experience requirements (6+ years for Bachelor's). Please do not submit Ph.D. candidates (considered overqualified).
KEY RESPONSIBILITIES & ESSENTIAL DUTIES
Laboratory Execution & Protocol Design:
Lead the design, execution, and troubleshooting of complex laboratory protocols, bench experiments, process characterization, and scale-up activities with minimal supervision.
Execute bench experiments, record meticulous observations, and conduct quantitative data analysis.
Process Transfer & Quality Standards:
Prepare manufacturing documentation and complete transfer activities for new products.
Champion "Quality First Time " standards while identifying and implementing process capability improvements in the laboratory environment.
Problem Solving & Subject Matter Expertise:
Serve as a technical resource to troubleshoot complex technical problems, institute corrective actions, and resolve intangible variables.
Optimize workflows and identify potential patent or publication opportunities.
Documentation & Technical Reporting:
Generate comprehensive technical reports, summaries, and experimental procedures.
Present findings and scientific data clearly to project teams, group meetings, and organizational stakeholders.
Collaboration & Leadership:
Partner actively across organizational boundaries and lead or participate in cross-functional technical teams (e.g., core teams, failure investigations).
Contribute to project planning, provide creative solutions, and mentor or train team members in areas of expertise.