Preclinical Operations Supervisor

Johnson & Johnson MedTech; Cincinnati (OH); On-site; USD 109,000 - 175,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours per year

Holiday pay – 13 days per year

Work and family time – 40 hours per yr

Parental Leave – 480 hours per year

Job summary

Johnson & Johnson MedTech in Cincinnati is seeking a Preclinical/Laboratory Operations Supervisor for hands-on leadership of the RAD Preclinical team. The role involves supervising operations, coordinating studies, managing supplies and regulatory compliance, and supporting documentation for regulatory submissions.

You will collaborate with R&D, Regulatory Affairs, and Quality Assurance to ensure lab safety and policy adherence, driving cross-functional success in a fast-paced medical device

Qualifications

• Bachelor’s degree in a related domain.
• Minimum of 3 years of relevant scientific experience, with a strong background in preclinical, medical, and/or clinical research or related fields.
• Knowledge of GLP requirements.
• Excellent oral and written communication skills with a keen eye for detail.
• Strong leadership and project management skills, including influencing, negotiating, and problem-solving.
• Experience with IACUC regulations, scientific experimental design, and protocol development.

Responsibilities

• Supervise and coordinate RAD Preclinical Operations in Cincinnati.
• Organize and support surgical laboratory research activities and supplies.
• Manage lab inventory, cadaveric tissue, waste, and regulatory compliance.
• Provide oversight to lab operations staff and plan team meetings.
• Develop and revise lab SOPs; ensure documentation is compliant.
• Support regulatory writing and IACUC documentation.

Skills

Leadership

Project management

Communication

Regulatory knowledge

Data synthesis

Education

Bachelor’s degree in related field

Tools

Microsoft 365

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job FunctionR&D Operations

Job Sub FunctionLaboratory Operations

Job CategoryPeople Leader

All Job Posting Locations:Cincinnati, Ohio, United States of America

Job DescriptionAbout SurgeryFueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of MedTech surgery? Ready to join a team that’s reimagining how we heal? Our MedTech Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. Learn more at https://jnjmedtech.com

Johnson and Johnson’s Robotics & Digital Solutions division (RAD) is searching for the best talent for a Preclinical/Laboratory Operations Supervisor role located in Cincinnati, OH. This is a fully on-site position.

PurposeRobotics & Digital Solutions is part of J&J MedTech, a global leader in surgery with products and solutions found in almost every operating room around the world. J&J MedTech has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through J&J MedTech’s surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact.

This is a hands-on role within the Preclinical team and represents an outstanding opportunity to work cross functionally with various groups that utilize the Preclinical Labs. Supervision, assistance, and support in this space will be essential to the development of J&Js highly innovative Ottava robotic and digital surgery platform. This position will also support the development of technical documents for Preclinical studies that inform J&Js regulatory submissions and evidence-generation strategies.

You Will Be Responsible For

Key Operations

• Overall supervision and coordination of RAD Preclinical Operations activities in Cincinnati
• Organizing, managing, and supporting various surgical laboratory research studies and research activities
• Management of surgical laboratory supplies, tools, robotic instruments, inventory and distribution in compliance with regulatory requirements and organizational procedures
• Provide oversight and direction to lab operations staff, including planning team meetings
• Management of vendor accounts and fostering relationships for ongoing surgical laboratory needs
• Management of cadaveric tissue and biohazardous waste
• Promoting environmental health and safety compliance in our labs per company policies
• Manage review and revision of relevant lab SOP’s on a quarterly basis or as necessary
• Ensure lab maintenance and instrumentation cleanliness/sterility in compliance with regulatory requirements and organizational procedures
• Ensure proper documentation and record keeping in compliance with regulatory requirements and organizational procedures

Key Technical Writing Skills

• Support developing, reviewing, and finalizing a wide range of scientific and regulatory documents including, but not limited to, scientific protocols and reports, post-operative evaluations, Quality audit edits and responses, responses to regulatory agencies, and IACUC documents.
• Perform literature searches to support research activities, IACUC documentation, and publications.
• Ensure all documentation complies with current regulatory standards, industry guidelines, and internal SOPs.
• Support change management activities.
• Foster strong, collaborative relationships with cross-functional teams including R&D, Regulatory Affairs, and Quality Assurance.

Required

Qualifications / Requirements:

• Bachelor’s degree in a a related domain
• Minimum of 3 years of relevant scientific experience, with a strong background in preclinical, medical, and/or clinical research or related fields
• Knowledge of GLP requirements
• Excellent oral and written communication skills with a keen eye for detail.
• Strong leadership and project management skills, including influencing, negotiating, and problem-solving.
• Demonstrated learning agility and ability to adapt to evolving technologies and regulatory landscapes.
• Experience with IACUC regulations, scientific experimental design, and protocol development
• Familiarity with 510(k) documentation and submission processes
• Copy editing, proofreading, and data synthesis skills
• Understanding of SOPs, research ethics, and quality standards
• Understanding of human/animal anatomy and surgical methods is desired
• Proficiency with Microsoft 365 applications, including Word, Excel, PowerPoint, and Copilot is required
• Ability to work independently and as part of a project team
• Proven organizational and time management skills are essential

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

BenefitsSubject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check

Required SkillsPreferred Skills:Analytical Reasoning, Data Management and Informatics, Developing Others, Epidemiology, Ethical and Participant Safety Considerations, Inclusive Leadership, Laboratory Operations, Laboratory Safety, Leadership, Mental Agility, Molecular Diagnostics, Motivating People, Process Improvements, Quality Assurance (QA), Regulatory Compliance, Research and Development, Team Management, Toxicology

The anticipated base pay range for this position is : $109,000.00 - $174,800.00