J&J Family of Companies Senior Staff Scientist, Industrial Microbiology in Raritan, New Jersey

The Johnson & Johnson Family of Companies, is recruiting for a Senior Staff Scientist, Industrial Microbiology to be located in Raritan, NJ.

Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Summary:

  • Technical leader and contributor in the area of industrial microbiology with responsibility to support all J&J locations worldwide with technical competency and resourcing gaps.

  • Supports compliance and risk-based evaluation and provides in-depth technical support for new and existing microbial controlled products including technology concepts, process development and validation activities.

  • External influencing- actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.

  • Lead and facilitate new method development for industrial microbiology testing applications.

  • Provide talent development and training of microbiology analysts and other associates that use microbiology for validation of processes.

  • Provide microbiology support to regional and enterprise laboratory testing to independently interpret data and identify and correct issues.

Responsibilities:

  • Performs applied research and development initiatives, including integrating new technologies and test methods into routine practice.

  • Develops creative microbiology solutions for sterilization/aseptic processing of products not amenable to traditional methods.

  • Integrator for new acquisitions to Sterility Assurance including performing gap analyses and developing corrective action plans.

  • Develops internal technical standards / guidance and establishing associated training programs

  • Conducts technical assessments to qualify suppliers and other contract services (contract testing labs and BI suppliers).

  • Co-Leads Microbiology Analyst Training and Certification Program and implement training programs and initiatives to develop microbiological skills.

  • Develops and executes strategies for Sterility Assurance Labs.

  • Supports equipment qualifications to ensure accuracy and consistency of results.

  • Provides support and direction to affiliate operating companies on new microbiology methods, process optimization, and trouble-shooting out of specification (OOS) test results. Determine root cause and prescribes robust effective corrective action.

  • Initiates and investigates non-conforming laboratory test results and advances sterility assurance issues to management.

  • Leads in the development of internal technical documents.

  • Leads troubleshooting of microbially nonconforming manufacturing processes

  • Participates and leads in external organizations to influence industry development of standards and or position papers.

  • Provides support to ensure that Sterility Assurance services tactical objectives are aligned with strategic organizational targets.

  • Collaborates with internal regulatory compliance and external Regulatory Authorities during on-site inspections and related to submissions.

Qualifications

Requirements:

  • Bachelor’s degree (or equivalent) in a relevant scientific/technical field is required.

  • A minimum of 10 years of relevant experience (for example, lab testing, executing lab studies, developing and validating test methods to support Sterility Assurance) is required.

  • Solid understanding of key processes and activities within Sterility Assurance, and the interdependencies and interactions with other functions is preferred.

  • Understanding of practices, and/or scientific theories and principles regarding tests, studies, developments, and validation of test methods executed within Sterility Assurance is preferred.

  • Experience leading, and/or providing instruction to, professional and technical employees on projects and initiatives is required.

  • Experience leading the troubleshooting of process non-conformances, out of specification test results, and failure investigations, as well as providing resolution to issues via robust CAPA is required.

  • Experience conducting audits of in-house Microbiology Labs, contract/external labs, manufacturing processes, and critical utilities (i.e. water systems, compressed gases, controlled environments) is required.

  • Strong understanding of, and ability to interpret, applicable regulatory agency regulations and industry standards, and maintains currency on pharmacopeia compendia is required.

  • 25% domestic and international travel is required as business demands.

Primary Location

United States-New Jersey-Raritan-

Organization

Johnson & Johnson International (6078)

Job Function

R&D

Requisition ID

6518190205