Job Summary

The Production Manager – NanoCept® Technology oversees Onkos Surgical’s Bridgewater NanoCept Innovation Center in Bridgewater, NJ. This includes overall responsibility for the site and end-to-end manufacturing operations for the specialized NanoCept surface processing lines. This role is responsible for safety, directing day-to-day production, inventory, calibration, preventative maintenance, scheduling, operator training, performance KPI’s, continuous improvement initiatives and most importantly, compliance. Additionally, this position will work closely with Quality Assurance and Quality Control ensuring process controls are maintained, validation protocols executed, and production trending is maintained. Lastly, the NanoCept Manager will have responsibility for Talent management and hiring based on capacity requirements.

The ideal candidate brings deep expertise in medical device/pharma manufacturing, cleanroom operations (ISO Class 7/8), precision measurement equipment, strict cGMP/FDA 21 CFR Part 820 compliance and team leadership.

Responsibilities

Production & Operational Excellence

• Daily Workflow Management: Direct daily manufacturing activities for NanoCept production, balancing schedule requirements, personnel/equipment capacity and daily stand-up meetings with the team to review daily goals.
• Process Execution: Ensure precise execution of controlled work instructions, maintenance of equipment, 5S, operator safety, raw material management, and transactional compliance through the company’s ERP system.
• Line Scalability & Throughput: Coordinate and prioritize process improvement objectives with the Product development team for Senior leadership recommendations. Key objectives would include scale, yield, raw material utilization, velocity and quality optimization.
• Layout & Optimization: Continually assess line layout, material flow, and ergonomic configurations to eliminate bottlenecks and optimize operational efficiency.

Equipment Qualification & Process Controls

• Validation Leadership: Supports execution and reporting of Installation, Operational, and Performance Qualifications (IQ/OQ/PQ) for new and existing production machinery.
• Equipment Oversight: Ensure adequacy and execution of the ssite’s daily, weekly, and monthly maintenance program for all essential equipment supporting NanoCept processing.
• Metrology & Inspection: Collaborate with Quality Engineering to ensure calibration of equipment is maintained, compliant, and documented.

Quality, Regulatory, & Compliance

• cGMP Standards: Enforce strict training and adherence to ISO 13485 standards, FDA Quality System Regulations (21 CFR Part 820), and internal Quality Management System (QMS) procedures.
• Deviations & CAPA: Support non-conformance investigations (NCMRs), Root Cause Analysis (RCA), and Corrective/Preventive Action (CAPA) implementations related to manufacturing process errors or out-of-spec parameters.
• Audit Readiness: Maintain audit-ready documentation for all device history records (DHRs), validation files, training documents and team readiness.
• EHS Compliance: Maintain a safe working environment, enforcing strict cleanroom gowning/hygiene protocols, hazardous chemical handling procedures (OSHA/EPA), and PPE standards and training to the same.

Site Management

• Interactual with Landlord to ensure compliance with the facility agreement including utilities, cleanliness, access, and security.

Team Leadership

• People Management: Hire, train, mentor, and evaluate a team of manufacturing technicians, leads, and cleanroom operators.
• Cross-Functional Collaboration: Serve as the primary liaison between Manufacturing, Quality Assurance, Regulatory Affairs, and R&D/Product Development teams.

Requirements

• Minimum of 7 years of progressive experience in medical device manufacturing and/or pharma operations with at least 3 years in a supervisory or management role.
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Materials Science, or a related technical discipline.
• Direct Experience with medical device surface processing, pharma processing and/or chemical coatings is a plus.
• Proven track record executing IQ/OQ/PQ validations for controlled manufacturing processes.
• Hands-on familiarity with ISO Class 7 or Class 8 cleanroom environments and environmental monitoring standards.
• Solid understanding of statistics, chemical handling, safety/ppe requirements and facility readiness.
• Strong command of Quality Management Systems (ISO 13485, FDA 21 CFR 820).
• Strong root-cause problem-solving abilities (5-Why, Fishbone, 8D, DMAIC).
• Clear cross-functional communication skills to present technical production metrics to executive leadership and clear work instructions to floor technicians.
• High adaptability and decision-making rigor under tight delivery timelines.
• Experience managing the transition of new medical device technologies from R&D/pilot scale into full commercial production.
• Hands-on experience with Lean Manufacturing, 5S implementation, and cellular manufacturing principles.
• Product Launch experience is preferred.

About Onkos Surgical

At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. We exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.

At Onkos Surgical, we will:

• Find solutions to our patients’ unmet clinical needs and advocate for their cause.
• Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.
• Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
• Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth.
• Deliver value to our customers and shareholders.