Preclinical Operations Supervisor

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.

Qualifications / Requirements:

Required:

• 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.

Subject 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

#LI-Onsite

Required Skills:

Preferred 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

Additional Description for Pay Transparency: