Associate Director, Process Engineering

POSITION SUMMARY

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

PRIMARY RESPONSIBILITIES AND DUTIES

Process Development:

• Lead a team of scientists and engineers to develop and optimize processes for complex biochemistry and cell biology laboratory testing

Cross-Functional Collaboration:

• Work closely with Engineering and R D teams to implement and maintain quality control of test processes

Assay Development:

• Develop molecular assays and define mechanisms of action in complex cell-based systems
• Establish test performance criteria and data quality standards

Statistical Design & Analysis:

• Design and execute statistical studies (Design of Experiments, screening designs) to identify key factors in complex assay systems

Process Lifecycle Management:

• Develop and maintain process plans from concept through validation and scale-up
• Support feasibility and development phase reporting

Documentation & Regulatory Support:

• Create pre-clinical documentation and support regulatory readiness

Equipment & Maintenance:

• Establish and implement maintenance and calibration programs for laboratory equipment in partnership with

Facilities Quality & Compliance:

• Support QA/QC programs
• Ensure adherence to safety standards, quality systems, and HIPAA requirements

Scientific Collaboration:

• Participate in cross-functional meetings and support translational and clinical study initiatives

QUALIFICATIONS AND SKILLS

Education & Experience:

• PhD or MS in bioengineering or related field
• Extensive experience leading scientific/engineering teams in complex laboratory environments
• Strong experience in process development and pre-clinical assay development
• Hands-on experience with laboratory process development and scale-up

About Us:

Celcuity is a clinical-stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first-in-class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with

HR+/HER2- ABC

in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on-going. 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 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.