Job Function:
R&D Product Development

Job Sub Function:
R&D Process Engineering

Job Category:
People Leader

All Job Posting Locations:
Raritan, New Jersey, United States of America

Job Description:

About Surgery:

Fueled 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 surgery? Ready to join a team that's reimagining how we heal? Our 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://www.jnj.com/medtech

We are searching for the best talent for an Associate Director, R&D Process Development to support our Biosurgery business. This role will be located in Raritan, NJ & work a Flex/Hybrid schedule with 3 days per week on-site. Relocation assistance is available for qualified candidates. A pre-identified candidate has been identified for this role, however all applications will be considered.

Purpose: The Associate Director, R&D Process Development role will design, optimize, and scale-up manufacturing processes for synthetic and biosynthetic medical device products. The role requires deep chemical and process engineering expertise across laboratory, pilot, and commercial scales, with a strong focus on reaction engineering, downstream processing, solids handling, process modeling and reliable manufacturing. The Associate Director R&D Process Development will partner closely with Technical Operations, Supply Chain and Quality, Regulatory and external manufacturing partners to establish robust, scalable, cost-effective and compliant processes from early development through to commercial production. You will own technology strategy, process characterization, and seamless technology transfer to manufacturing, while building and mentoring a high-performing team of process engineers.

This R&D role will lead a multi-disciplinary team of scientists and engineers to advance Biosurgery products from charter approval through launch and stabilization to deliver safe, compliant, and competitive products to market.

You will be responsible for:

• Drive the end-to-end process development for biosynthetic medical device products, from laboratory and pilot scale process development through scale-up and commercial manufacturing transfer.
• Develop scalable, robust manufacturing processes that meet scope, schedule, cost, quality and regulatory targets.
• Translate process and technology roadmaps into actionable stage-gate plans, resource allocation, milestone schedules and mitigation strategies.
• Partner with Formulation, Technical Operations, Manufacturing, and Quality teams to select equipment, automation, and process technologies.
• Establish and track KPIs for process control, including continuous improvement programs to sustain process performance.
• Drive design for manufacturability and design-to-cost initiatives.
• Collaborate closely with cross-functional team to ensure technology transfer activities from development to production lines, including support in process validation (IQ/OQ/PQ), commissioning, and start-up support.
• Ensure compliance with medical device regulatory and quality requirements (e.g., 21 CFR 820 / FDA QSR, ISO 13485, ISO 14971) and support regulatory submission readiness as needed.
• Manage relationships with contractors, external vendors, CMOs/CDMOs, and consultants.
• Design, run, and analyze design of experiments (DOE) and other statistical methodologies to understand critical process parameters and their impact on quality and yield.
• Represent R&D Process Development function in governance forums and provide transparent reporting on portfolio status, risks and mitigation plans.
• Lead, mentor and grow a high-performing team; set priorities, develop capabilities, and manage performance and foster a culture of scientific rigor and continuous improvement.
• Communicate progress, risks, and strategic decisions to senior leadership and cross-functional partners; translate complex technical concepts into clear business implications.
• Promote a culture of safety, continuous improvement, innovation, and compliant documentation practices.

Qualifications / Requirements:

• PhD in Chemical Engineering or a closely related field is required.
• 10+ years of experience in process development, process scale-up, and manufacturing transfer with strong engineering foundation is required.
• 3+ years of people leadership experience with the ability to lead multidisciplinary teams is required.
• Strong background in one or more of the following process areas common to medical devices: polymer synthesis, purification, lyophilization, milling, coloration, and sterilization, with a bias toward developing reliable, scalable polymer manufacture.
• Demonstrated success in leading projects from development to manufacturing to meet commercial production objectives.
• Familiarity with product development lifecycle, design controls, verification and validation, risk management, supplier qualification and quality systems is required.
• Experience with materials/chemistry relevant to biosurgery products (e.g., polymers, hemostats, adhesives, tissue sealants, biologic formulations) is required.
• Proficiency with process characterization, design of experiments (DOE), statistical analysis, structured problem-solving (root cause analysis, corrective actions) and modeling / simulation is required.
• Experience managing external partnerships (CMOs/CDMOs, suppliers, academic collaborations, contractors) is required.
• Track record of cross-functional collaboration with R&D, Regulatory, Quality, Manufacturing, Clinical and Commercial teams.
• Demonstrated ability to develop individuals and build high-performing teams is required.
• Strong project management skills including stage-gate governance, risk management, schedule control, budgeting, and stakeholder reporting.
• Strong written and verbal communication skills with ability to influence without formal authority, senior leadership and external partners.
• Travel: Domestic and International up to 25% is required.

Preferred

• Experience in medical devices or similarly regulated industries (e.g., pharma, biotech) is preferred.
• Demonstrated success leading projects through regulatory submission is preferred.
• Working knowledge of medical device quality and regulatory requirements (21 CFR 820 / FDA QSR, ISO 13485), CAPA, change control, etc is preferred.
• Direct experience with commissioning, IQ/OQ/PQ, Validation Master Plans, and process validation for device manufacturing is preferred.
• Experience with Design Control and risk assessment methodologies (e.g., FMEA) is preferred.
• Experience with GMP (Good Manufacturing Practices) is preferred.

Required Skills:

Preferred Skills:
Agile Decision Making, Corrective and Preventive Action (CAPA), Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Engineering, Inclusive Leadership, Leadership, Process Control, Product Costing, Program Management, Project Schedule, Quality Assurance (QA), Regulatory Compliance, Research and Development, SAP Product Lifecycle Management, Team Management, Technical Research, Technologically Savvy

The anticipated base pay range for this position is :
$137,000.00 - $235,750.00

Additional Description for Pay Transparency:
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)).

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 additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits