Sr. Scientist, Biomaterials R&D

SECTION 2:DUTIES & RESPONSIBILITIES*

The Senior R&DScientistwill supportdesignanddevelopmentofcomplexmedical devicesand projectsproviding technicalexpertisetocross-functional project teams through all phases of the productlife-cycle.The Senior R&D Scientistwill function as a subject matter expert in biomaterials science and chemistry andwill organize plan execute and overseeprototypingand testing ofnew technologiesforprojects throughdevelopment regulatory filingproduct launchandcommercialization.

Under general direction andin accordance withall applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines key responsibilities for this position include:

• Act as a technical teammemberof a cross-functional project core team (marketing manufacturing quality testing supply chain regulatory etc.).

• Coordinates with design engineers marketing quality supply chain manufacturing regulatory affairs and other functional departments todevelop and test new product concepts.

• Independently develop testing protocols using laboratory instruments following standardmethodsor designing custom methods.

• Performs and or coordinates laboratory tasks in a safe mannerinanalytical chemical polymerR&Dlabs.

• Development and execution of design verification andvalidationplans and activities and test plan formation and execution to support global regulatory strategy.

• Supportsdevelopmentof intellectual property for novel designs.

• Collaborate with supply chain manufacturingengineeringand/or suppliers to optimize designs for manufacturability and assembly to produce functioning prototypes andsupportingproduction documentation.

• Designs and executes or coordinates scientific experimentspresentdata and conclusions withappropriate analysisandwritestechnical reports.

• Demonstrateproficiencyin the application of statistical methods for test method development and verification and validation activities

• Understands and follows the New Product Development process accurately andmaintainshigh quality design validation and verifications.

• Maybe responsible foroperatingwithin a budget and provide input on budget allocation and prioritization.

• Perform quality/compliance activities in support of audits remediation projects non-conformances regulatorycompliance projects.

• Diligentlyparticipatein our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

• Responsible for communicating business related issues or opportunities tonextmanagement level.

• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures

• Performs other duties assigned as needed
  

SECTION 3:EXPERIENCEAND EDUCATION*

• A minimum of six years of experience in the developmentortestingof biomaterials and biologicsbasedmedical devices drug productsor combination products.

• MSinChemistryMaterials Science or equivalent required.APhDdegree is preferred.

• Experience working in medical device regulations including GMP (Good Manufacturing Practices) QSR (Quality Systems Regulations) and ISO (International Organization for Standardization) quality requirementsispreferred.

SECTION 4:REQUIRED KNOWLEDGE SKILLS ABILITIESCERTIFICATIONS/LICENSESand AFFILIATIONS*

• Knowledge of biomaterial technologiesand chemical test methodsis

• Strong communicationskills - The ability to effectively communicate concepts ideas and knowledge to upper management other individuals customers e.g. Health Care Professionals and/ or teams across the organizationis. Ability to work effectively as a technical leader and sometimes as a project leader.

• Possess strong organizational skills to support all aspects of the project management functions including scope definition budgeting and contingency planning.

• Excellent problem solving decision-making and root cause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations is.

• Mustdemonstratea strong initiative and follow through in executing project responsibilities overcomingobstaclesand balancing multiple priorities effectively through strong technical and/or project leadership experience.

• Must have the ability to effectively communicate concepts ideas and knowledge to other individuals Health Care Professionals customers and/ orteams and work effectively as a technical leader and sometimes as a project leader.

• The ability to review and critically assess patents and other forms of intellectual property is preferred.

• Proficiencyutilizingthe MS Office Suite (Word Excel PowerPoint etc.) is.