HireDiversity

Raritan, NJ, US

SR. DIRECTOR ASEPTIC PROCESSING-0000095E

Description

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

The Senior Director Aseptic Processing influences the company's strategic and tactical directions and financial results through the application of technical knowledge and expertise in aseptic processing and related Quality Systems for Pharma, Biologic and Combination products. Performs complex design and risk analyses and provides input or approval for facility, large equipment and process design specifications, qualifications, validations and control programs. The position has a direct contribution to the development of functional strategies and has responsibilities for also managing the Quality Systems and training organization for Sterility Assurance.

The Senior Director Aseptic Processing directs compliance and risk based evaluations and provides in-depth technical support for new sterile products and aseptic processes, technology concepts and process development and validation activities. Proposes solutions and pushes the organization to resolve difficult problems and address knowledge and/or resource gaps. Provides direction on quality and compliance requirements that satisfies global regulatory requirements and cGMP expectations. Plays a strategic leadership role in providing technical support for process changes, new or modified aseptic processing facilities, failure investigations and root cause analyses. Assist in readiness reviews in advance of regulatory agency inspections, as well as responding to regulatory citations and other enforcement actions. Advocates for the implementation of innovative quality risk management and QbD programs and assists in due diligence and on-site technical assessments. Represents J&J at key industry standards organizations and influences regulations and standards. Develops J&J Entrprise-wide technical standards and guidance documents on aseptic processing and controlled bioburden manufacturing operations. Delivers world class training and sets the curriculum for aseptic processing training globally. Leads and manages talent and implements training and development initiatives to optimize staff skills. Oversees the Sterility Assurance support provided to the manufacture of products that are aseptically manufactured.

Qualifications


Individual must have an undergraduate degree in Engineering or Microbiology/Biology or closely related discipline with a minimum of 20 years related experience is required. An advanced degree is preferred. The candidate will have hands on experience in aseptic processing operations. A strong background in R&D is also required. A high level detailed knowledge of AAMI/ISO standards is required. Prior experience participating at a high level and/or leading industry standards working group(s) in the area of Aseptic Processing would be desired. Demonstrated expertise through authored multiple peer reviewed publications is a plus. It is also desired that the successful candidate exhibit high level skills in risk assessments and the design of experiments/validation. A proven track record on trouble shooting process non-conformances and out of specification test results and providing resolution to issues via robust CAPA is a requirement. Demonstrated experience conducting audits of in-house and contract aseptic processing required.

Individual must have demonstrated capability to lead and train a large a diverse, multinational community with multiple stakeholders, working in a supervisory, coaching, mentoring and/or influencing capacity with a demonstrated ability to act as a subject matter expert in the area of Aseptic Processing on behalf of the organization both internally and externally. The candidate must be capable of representing the corporation on industry standards association such as AAMI, PDA, etc. and have experience in conducting training on industry practices and standards. This position will typically require up to 30% domestic and International travel, but may be higher depending on candidate location and business need. It is preferred that this position will be located in Raritan, NJ, USA or may be located at an appropriate JNJ facility worldwide.

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Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America, Europe/Middle East/Africa, Latin America, Asia Pacific
Organization: Johnson & Johnson International (6078)