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

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 were 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 thats 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 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 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 please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

Bioinformatics Biological Engineering Biostatistics Clinical Trials Operations Coaching Communication Critical Thinking Global Market Healthcare Trends Medical Affairs Organizing Product Development Project Reporting Research and Development Researching Resource Planning SAP Product Lifecycle Management

The anticipated base pay range for this position is :

$117000.00 - $201250.00

Additional Description for Pay Transparency:

Please provide the benefits applicable. Required for US Positions. Please copy and paste the applicable benefits into the empty text box below based on the type of role.

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



This position is eligible to participate in the Companys 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
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