Associate Director, Assay and 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

Position Summary

Reporting to the Chief Science Officer, the Associate Director, Assay and Process Development works within a high-complexity, cellular, and molecular testing laboratory to develop processes, procedures, and products from conception to production for GLP level pre-clinical test products.

Position Summary

Reporting to the Chief Science Officer, the Associate Director, Assay and Process Development works within a high-complexity, cellular, and molecular testing laboratory to develop processes, procedures, and products from conception to production for GLP level pre-clinical test 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.

Additional Duties And Responsibilities

• Participate in set-up of and data generation for translational medicine clinical studies.
• Plan with other Directors and participate in routine science meetings with team members from Research, Development, and Tissue Culture Areas

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.
• Experience requiring a high percentage of hands-on time in the lab leading and working with teams to build processes and successful products.

Competencies

• Language Ability: Ability to read and interpret documents such as safety rules, governmental regulations, and science/engineering technical or professional journals. Ability to write reports, document data; and to speak effectively before small groups.
• Math Ability: Ability to apply fractions, percentages, reliability and validity to work situations. Ability to work with logarithms and exponents. Ability to develop complex algorithms to analyze experimental data and apply those algorithms in an economical manner to process large data sets uniformly.
• Reasoning Ability: Ability to apply principles of scientific thinking to a range of practical and intellectual issues. Consistent use of inductive and deductive reasoning.
• Computer Ability: Proficiency in Microsoft Word, Excel, and PowerPoint, Statistical analysis (egs. JMP, R), Design of Experiment software, MatLab or equivalent, SolidWorks or equivalent drafting software.
• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures. Applies complex statistical analyses.
• Design - Generates creative solutions; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
• Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions.
• Ethics - Works with integrity and ethically.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
• Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Develops realistic action plans.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Monitors own work to ensure quality.

Other

• Supervisory Responsibility: 1-5 persons as needed
• Work Environment: This position requires the employee to work in a laboratory environment. Typically, standard business hours; flexibility required.

About Celcuity

Celcuity is a commercial biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's first FDA-approved product is REVTORPYK (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. REVTORPYK is approved to treat adults with HR+/HER2- advanced breast cancer that progressed on prior endocrine therapy in the metastatic setting.

The Phase 3 VIKTORIA-2 trial is evaluating gedatolisib in combination with palbociclib and either fulvestrant or letrozole for the first-line treatment of HR+/HER2- locally advanced or metastatic breast cancer. A Phase 1/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive.

For this role, the anticipated base pay range is $120,000 - $150,000 DOE. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.