PD Project Lead

Nucleix Ltd. develops, manufactures, and brings to market innovative non-invasive cancer molecular diagnostics tests. The company’s EpiCheck™ core technology combines robust and highly sensitive biochemistries with sophisticated algorithms to detect subtle cancer-specific changes in DNA methylation patterns and deliver excellent clinical performance. Bladder EpiCheck™ is the company’s first on-market urine test for monitoring bladder cancer recurrence and is followed by an active pipeline focused on developing best-in-class yet affordable blood tests for early detection of lung cancer.

We encourage you to express your interest in this opportunity by sending your responses directly to us. Please send your application or reactions to: [email protected]. We look forward to hearing from you!

JOB SUMMARY:

We are seeking a highly motivated Project Lead to drive the development of innovative products based on qPCR technology. The ideal candidate will have a background in the pharmaceutical, biotechnology, diagnostic, or medical device sectors, combining expertise in molecular biology, and project management to deliver high-performance products. You will be responsible for independently creating lead product development projects and writing technical documentation, including design history files, technical protocols, and reports, in compliance with industry regulations. You will lead post-market design change assessments, troubleshooting, and process improvements, ensuring smooth execution and adherence to timelines and budgets.

while supporting initiatives that foster continuous improvement across the organization.

This role requires a strong commitment to quality, attention to detail, and the ability to lead projects with minimal supervision, while collaborating with cross-functional teams to achieve impactful results.

Responsibilities:

·      Develop and maintain project plans, ensuring alignment with technical milestones, timelines, and budget constraints.

·      Oversee product development and company-related projects to ensure smooth execution.

·      Independently create technical documentation to support product development and regulatory submissions including design history files, technical protocols, and reports.

·      Review product development documentation to ensure accuracy and compliance.

·      Contribute to post-market design change assessments, process improvements, and troubleshooting.

·      Ensure compliance with the company’s Quality Management System and support quality initiatives to foster continuous improvement across the organization.

·      Conduct statistical analyses

·      Perform verification and validation experiments, when required.

·      Handle and process human clinical specimens, as needed.

·      Perform other related duties as assigned

Requirements:

• Proven experience leading multidisciplinary projects and collaborating across teams.
• Strong organizational and project management abilities.
• Master’s degree (+6 years’ experience), or PhD (+3 years’ experience) in Biology or related fields.
• Familiarity with standard molecular biology techniques, such as qPCR is essential
• Experience in the development of in vitro diagnostics, medical devices, and/or drug products is an advantage
• Knowledge of product development lifecycle.
• Experience leading and mentoring junior staff; prior management of direct reports is a plus.
• Ability to thrive in a fast-paced, dynamic startup environment with strong self-motivation and organizational skills.
• Ability to execute high-profile tasks with minimal supervision.
• Strong problem-solving and critical thinking abilities.
• Excellent analytical capabilities.
• Excellent written and verbal communication skills in English.
• Strong interpersonal skills and a collaborative team player.
• Proactive in addressing challenges and issues.
• Proficient in computer and IT tools.

·      A strong commitment to quality and continuous improvement.