Associate Director, Assay and Process Development
Celcuity
September 03, 2026
On-site
Minneapolis, MN
Clinical Research and Development
Responsibilities:
- Lead teams of scientists and engineers to plan and build processes for highly complex biochemistry and cell biology testing.
- Work with Principal Investigators and R&D Lab teams to implement and maintain quality control of test processes.
- Develop new molecular assays for pre-clinical decision-making and mechanisms of action in complex cell assay environments.
- Develop test quality criteria; generate data quality reports.
- Create assay/test performance specification documents with CSO and the Assoc./Director of R&D Laboratory.
- Develop and review Feasibility and Development Phase Plans/Reports with CSO, including statistical analyses and recommendations based on acceptance criteria.
- Create and execute Definitive Screening Design/Design of Experiments studies to identify controlling factors in high complexity live cell assays.
- Create and maintain process and procedure plans through validation.
- Develop test/process scale-up plans with CSO, Assoc./Director, and oncology investigators.
- Create pre-clinical documentation with CSO and Director Oncology.
- Participate in review/approval processes for each phase of assay development.
- Implement maintenance and calibration program for laboratory equipment; support safe workplace.
- Support HIPAA compliance and laboratory SOPs; contribute to QA/QC programs.
- Participate in staff reviews as needed; report to work as scheduled.
Additional duties:
- Support translational medicine clinical study setup and data generation.
- Participate in routine science meetings with Research, Development, and Tissue Culture teams.
Qualifications:
- PhD/MS in a related bioengineering (bio)engineering field.
- Extensive experience leading scientists/engineers to solve complex problems and deliver timely results.
- Extensive experience developing processes and pre-clinical assay products using high-complexity metrics and statistical analyses.
- Hands-on lab experience leading and building successful processes/products.
Skills/Tools/Competencies (required/preferred):
- Proficiency in MS Word/Excel/PowerPoint; statistical analysis (e.g., JMP, R); DOE tools; MatLab (or equivalent); SolidWorks (or equivalent).
- Strong analytical, design, problem-solving, ethics, innovation, judgment, planning/organizing, and quality focus.
Other:
- Supervises 1–5 persons as needed; works in a laboratory environment with standard business hours and flexibility required.
- Lead teams of scientists and engineers to plan and build processes for highly complex biochemistry and cell biology testing.
- Work with Principal Investigators and R&D Lab teams to implement and maintain quality control of test processes.
- Develop new molecular assays for pre-clinical decision-making and mechanisms of action in complex cell assay environments.
- Develop test quality criteria; generate data quality reports.
- Create assay/test performance specification documents with CSO and the Assoc./Director of R&D Laboratory.
- Develop and review Feasibility and Development Phase Plans/Reports with CSO, including statistical analyses and recommendations based on acceptance criteria.
- Create and execute Definitive Screening Design/Design of Experiments studies to identify controlling factors in high complexity live cell assays.
- Create and maintain process and procedure plans through validation.
- Develop test/process scale-up plans with CSO, Assoc./Director, and oncology investigators.
- Create pre-clinical documentation with CSO and Director Oncology.
- Participate in review/approval processes for each phase of assay development.
- Implement maintenance and calibration program for laboratory equipment; support safe workplace.
- Support HIPAA compliance and laboratory SOPs; contribute to QA/QC programs.
- Participate in staff reviews as needed; report to work as scheduled.
Additional duties:
- Support translational medicine clinical study setup and data generation.
- Participate in routine science meetings with Research, Development, and Tissue Culture teams.
Qualifications:
- PhD/MS in a related bioengineering (bio)engineering field.
- Extensive experience leading scientists/engineers to solve complex problems and deliver timely results.
- Extensive experience developing processes and pre-clinical assay products using high-complexity metrics and statistical analyses.
- Hands-on lab experience leading and building successful processes/products.
Skills/Tools/Competencies (required/preferred):
- Proficiency in MS Word/Excel/PowerPoint; statistical analysis (e.g., JMP, R); DOE tools; MatLab (or equivalent); SolidWorks (or equivalent).
- Strong analytical, design, problem-solving, ethics, innovation, judgment, planning/organizing, and quality focus.
Other:
- Supervises 1–5 persons as needed; works in a laboratory environment with standard business hours and flexibility required.