WHO WE ARE

Our vision at On Target Laboratories is to brighten the future for those fighting cancer by making cancer visible intraoperatively so it can be removed more completely with our cancer-targeted intraoperative molecular imaging agents.

We are an agile, tenacious, collaborative biotechnology start-up with a relentless focus on advancing real- time cancer imaging. Our end game is helping people fight cancer, boldly pushing boundaries to advance science, technology, and humanity.

Our intraoperative molecular imaging agents, based on the pioneering work of Purdue University’s Philip S. Low, PhD, illuminate cancerous tissue, which may enable surgeons to detect more cancer that otherwise may have been left behind.

CYTALUX (pafolacianine) injection, On Target’s first product, received FDA approval for ovarian cancer in November 2021 and lung cancer in December 2022. For more information visit www.ontargetlabs.com and www.cytalux.com.

WHAT YOU WILL DO

As the Quality Assurance Supervisor you will play a significant role in ensuring the On Target’s products and processes meet FDA regulations and related industry standards. You will formulate and supervise the quality processes within a commercial pharmaceutical organization.

This is a remote based position with at minimum quarterly company-wide meetings either at the On Target headquarters in West LaFayette, Indiana or a location as identified by Executive Management.

The ideal candidate would be located in either the Central or Eastern time zones.

This position has no direct reports.

PRIMARY RESPONSIBILITIES

• Develop/improve, implement, and maintain the quality management system (QMS) to comply with FDA, applicable international, and related industry guidelines.
• Stay up-to-date with evolving quality assurance requirements and industry best practices, ensuring the organization’s compliance.
• Assist in the development, compilation, review, and approval of other quality-related documentation, such as standard operating procedures, product quality complaints, annual product quality reviews, analytical test methods, validation protocols and reports (equipment, process, analytical method), risk assessments, quality and technical agreements, etc.
• Provide training and mentorship to team members, ensuring they are adequately trained and knowledgeable in regulatory requirements, quality principles, and internal policies and procedures.
• Undertake the review, investigation (as appropriate), and approval of (pre- and post-execution) batch records including associated supporting documentation, such as deviations, out of specification results, change controls, corrective and preventive actions, and quality control test results.
• Oversee the evaluation and management of suppliers to ensure the quality of products or services provided by GxP suppliers.
  • Conduct supplier audits to assess compliance with quality standards, identify areas for improvement, and ensure adherence to procedures.
• Generate reports on quality performance metrics.
• Work with Clinical Operations to develop and implement clinical quality risk management strategies for investigator sites suppliers, clinical documentation and systems ensuring compliance with Good Clinical Practices (GCP).
• Collaborate with other departments, such as CMC, Clinical, Research and Development, and Regulatory Affairs, to ensure consistent quality across all aspects of the product lifecycle.
• Drive Quality Improvements: Identify and resolve quality issues and lead initiatives for continuous improvement.
• Monitor and Report Quality Metrics: Track key quality indicators and share insights with executive leadership to support ongoing improvement efforts.

QUALIFICATIONS & SKILLS

• Bachelor’s degree in a scientific field (e.g., biology, chemistry).
• Minimum 4 to 6 years’ experience in pharmaceutical manufacturing and quality assurance.
• Strong knowledge of FDA regulations and other relevant quality and related industry standards.
• Experience in sterile manufactured products preferred with small molecules being ideal.
• Excellent communication, and interpersonal skills.
• Strong analytical and problem-solving skills.
• Proficiency in quality management systems and data analysis tools.
• Exposure to Regulatory Affairs or an interest in learning the Regulatory Affairs role is a plus.

On Target Laboratories, Inc. is an Equal Opportunity Employer. On Target Laboratories, Inc. does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non- disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.