Johnson & Johnson Careers
Associate Director, Ethicon Biosurgery (Formulation Development)
Requisition ID: 7944190619
Ethicon Biosurgery R&D is recruiting for an Associate Director, Ethicon Biosurgery (Formulation Development), located in Somerville, NJ.
Ethicon Biosurgery R&D is recruiting for an Associate Director, Formulation Development, located in Somerville, NJ. Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 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 Ethicon's surgical technologies and solutions including 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. For more information, visit www.ethicon.com.
The Associate Director of Formulation Development, Biosurgery R&D is responsible for leading a highly technical team of varied subject matter expertise to develop robust formulations and delivery systems to achieve Biosurgery’s platform innovation objectives. He/she connects end-to-end with the Biosurgery R&D technical community to input and resource from exploratory initiatives (front end) to life cycle management. He/she looks to future needs to build necessary capabilities and continuity of expertise. Responsibilities include:
- Deliver all chemical/biologic components to market from PoP through plant scale up.
Partner with Global Strategic Marketing (GSM) to lead diverse team of technical experts to identify customer insights and translate into customer requirements and design input, including formulation requirements
Lead development of differentiated/ownable medical device and biological systems that provide competitive advantage to support business growth beyond category growth
Integrate perspectives and needs from cross functional partners including diverse R&D team (e.g. Preclinical to Regulatory) to shape solution and inform execution
Ensure compliance to all regulatory and quality requirements
Lead the formulation subject matter experts to provide technical expertise and leadership through the stage gate process from PoP to scaling up in the plants, as well as design control deliverables and technical documents for regulatory submission.
Lead team through Stabilization phase and transition to LCM team
Remove barriers and resolve issues to execute pipeline initiatives on schedule for business commitments.
Partner across front end and LCM:
Assist the exploratory team in evaluating commercial feasibility for early phase initiatives, deploy resources as needed to help bring to proof of concept
Assist the life cycle management team to deploy the SME resources in evaluating impact of material changes, supplier discontinuity, and troubleshoot any formulation-related issues to marketed product
Create flexible resource model to share technical expertise from end-to-end
Incorporate design for manufacturing principals end-to-end into formulation development to drive manufacturability and profitability while delivering disruptive innovation
Develop diverse R&D team with interdisciplinary mindset.
Develop team skills in complex collaborations across all functions
Develop formulation capabilities to meet future needs, and create succession plans for technical talent
Depth of experience in designing medical device and/or biological solutions (product+education etc) based on customer needs is required
Knowledge of new product registration requirements from FDA, EMA, PMDA and etc is required.
Experience in 2-3 design & development of PMA, BLA and 510K products is required.
· People management and talent development experience is required
- Strong project management skills are required
- Strong change leadership skills are required
Solid collaboration skills, in complex environments is required
Good knowledge of deal structures and due diligence needs is required
- Good fiscal discipline is required
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability
United States-New Jersey-Somerville-
Ethicon Inc. (6045)