Associate Director, Assay & Process Development

Celcuity Inc.; Minneapolis, Northern (MN, KY); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) match

Paid time off and holidays

Job summary

Celcuity is seeking an Associate Director of Assay and Process Development to lead a high-clarity laboratory team, driving the conception, development, validation, and transfer of complex pre-clinical testing processes. You will work closely with CSO and R&D leaders to define quality criteria and generate robust data for decision making.

The role emphasizes hands-on leadership, statistical design, and cross-functional collaboration to ensure compliant, scalable assay development from concept

Qualifications

• PhD/MS in related (bio)engineering 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.

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

Team leadership

Statistical analysis

Experimental design

Lab mentorship

Education

PhD in bioengineering or related field

Tools

JMP

R

Design of Experiment software

MATLAB

SolidWorks

Job description

Celcuity is seeking an Associate Director of Assay and Process Development to lead a high-clarity laboratory team, driving the conception, development, validation, and transfer of complex pre-clinical testing processes. You will work closely with CSO and R&D leaders to define quality criteria and generate robust data for decision making.

The role emphasizes hands-on leadership, statistical design, and cross-functional collaboration to ensure compliant, scalable assay development from concept