Associate Director, Strategic Assay & Process Development

Celcuity; Minneapolis (MN); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Annual performance incentive bonus

New hire equity package

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Paid holidays

Job summary

Celcuity in Minneapolis, MN seeks an Associate Director, Assay and Process Development to lead a high‑complexity cellular and molecular testing lab, guiding from conception to production of GLP pre‑clinical test products. The role reports to the Chief Science Officer and drives process development and assay creation.

You will work with Principal Investigators and R&D teams to design robust assays, set quality criteria, and manage DOE studies and data reporting.

Qualifications

• PhD or MS in a related bioengineering field.
• Extensive experience leading teams of scientists/engineers to solve complex problems and deliver results in a timely way.
• Extensive experience developing processes and pre-clinical assay products, developing and applying appropriate high complexity metrics and statistical analyses.
• Experience requiring a high percentage of hands-on time in the lab leading and working with teams to build processes and successful products.

Responsibilities

• Lead team of scientists and engineers to plan and build processes for highly complex, high quality biochemistry and cell biology laboratory testing.
• Work directly with Principal Investigators and R&D Laboratory team to implement and maintain quality control of test processes.
• Develop new molecular assays for pre-clinical decision making, defining mechanisms of action in complex cell assay environment.
• Develop test quality criteria and generate data quality reports.
• Create assay/test performance specification documents in conjunction with CSO and Assoc/Director of R&D Laboratory
• Develop and review Feasibility and later Development Phase Plans and Reports with CSO, performing all relevant statistical analyses, and making specific recommendations based upon acceptance criteria conclusions.
• Create, lead, execute Definitive Screening Design, Design of Experiment statistical studies to identify controlling and interacting factors in high complexity live cell assays.
• Create and maintain process and procedure plans from concept through validation phases.
• Develop test/process scale up plans with CSO, Assoc/Director of R&D Laboratory, Oncology investigators.
• Create pre-clinical documentation with CSO and Director Oncology
• Participate in review and approval processes for each phase of assay development
• Create and implement a stringent program for maintenance and calibration of laboratory equipment with lab systems and facilities manager.
• Work with Director R&D Laboratory and Quality Manager to maintain a safe workplace.
• Support the Quality Manager with compliance for HIPAA requirements and laboratory standard operating procedures.
• Support lab quality assurance/quality control (QA/QC) programs.
• Participate in staff reviews as needed.
• Report to work as scheduled.

Skills

Leadership

Statistical analyses

Hands-on laboratory work

Communication

Education

PhD in related bioengineering

MS in related field

Tools

Microsoft Office

JMP

R

DOE software

MATLAB

SolidWorks

Job description

Celcuity in Minneapolis, MN seeks an Associate Director, Assay and Process Development to lead a high‑complexity cellular and molecular testing lab, guiding from conception to production of GLP pre‑clinical test products. The role reports to the Chief Science Officer and drives process development and assay creation.

You will work with Principal Investigators and R&D teams to design robust assays, set quality criteria, and manage DOE studies and data reporting.