Principal Scientist, R&D – Orthopedics & Spine, Growth Factors

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 Function: R&D Product Development Job Sub Function: Biomedical Engineering Job Category: Scientific/Technology All Job Posting Locations: Raynham, Massachusetts, United States of America, West Chester, Pennsylvania, United States of America Job Description: About Orthopaedics 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 Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. 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 the Principal Scientist, R&D – Orthopedics & Spine, Growth factors role , it will be located in West Chester, PA or Raynham, MA. Department: R&D – Biologics & Biomaterials Purpose: As a global leader in orthopedic medical devices, we are committed to advancing patient care through innovative biologics and regenerative solutions. We are seeking a highly specialized Principal Scientist to support our partnership with CG BIO, focusing on the commercialization and expansion of the Novosis portfolio. In this pivotal R&D role, you will be the resident subject matter expert on growth factors combined with bone graft substitutes. You will lead the technical collaboration to successfully introduce Novosis putty for spine indications, as well as explore optimal form factors/formulations for other indications. You will be responsible for: Product Development & Partnership Management Serve as the primary subject matter expert and technical point of contact for the CG BIO partnership, leading activities and technical decisions between external R&D teams and internal DePuy Synthes teams for initial global launches as well as during product lifecycle management. Partner with CG BIO on technical initiatives to optimize and improve Novosis formulations and procedural kits, ensuring handling characteristics, release kinetics, and bioactivity meet the demands of the global spine and trauma markets. Translate user needs from orthopedic and neurosurgeons into actionable technical specifications for concepts in the CG BIO innovation pipeline. Lead brainstorming and technical collaborations with CG BIO to develop the highest priority concepts with robust development, pre-clinical, clinical, regulatory and reimbursement strategies Surgeon Education & Commercial Support Act as the primary subject matter expert on rhBMP-2 and advanced bone graft substitutes for internal teams and external stakeholders. Develop comprehensive technical training modules and educational materials for the global sales force and marketing teams. Engage directly with KOLs, spine surgeons, and trauma specialists to conduct peer-to-peer technical education, lead surgical training labs, and gather customer feedback. Present at global technical conferences to educate the industry on the value of Novosis technology Evidence Generation & Dissemination Partner with Medical Affairs, Health Economics & Market Access (HEMA) and Clinical to design and execute robust evidence generation strategies to substantiate product efficacy and support regulatory submissions globally. Analyze complex biochemical and biomechanical data to create compelling marketing collateral that differentiates the Novosis portfolio. Author white papers, scientific publications, and technical reports to establish a strong clinical foundation for growth factor technologies. Qualifications / Requirements: Required Education: Advanced degree (Ph.D. or Master of Science) in Biomedical Engineering, Materials Science, Molecular Biology, or a closely related highly technical discipline. Required Experience & Skills: Industry Experience: Minimum of 8 years of progressive R&D or technical leadership experience within the medical device, biotechnology, or pharmaceuticals sector. Subject Matter Expertise: Documented expertise in growth factors and osteoinductive materials Clinical Domain Knowledge: Experience working directly within the spine or orthopedic trauma spaces, with an understanding of surgical workflows, fusion criteria, and bone healing biology. Biomaterials: Proven track record of working with carrier materials (collagen sponges, synthetic putties, granules) and improving handling characteristics or pharmacokinetic release profiles. KOL Engagement: Demonstrated success in educating and partnering with surgeons. Regulatory Knowledge: Strong working knowledge of the US regulatory landscape for biologics and combination products (BLA, PMA, 510(k), HCT/P) with experience supporting regulatory submissions to the FDA Preferred Qualifications: Prior experience managing external R&D partnerships, international partnerships, or technology transfers. Previous track record of launching a novel biologic or combination product into the US orthopedic market. Experience supporting successful regulatory clearances/approvals in the US, EMEA or APAC Strong business acumen with experience in voice of customer interviews, business case creation, regulatory strategy, pre-clinical models, clinical trials and project management. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 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 and 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,