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Principal Scientist, Aseptic Processing

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Job Description


Johnson & Johnson is recruiting for a Principal Scientist, Aseptic Processing in the Microbiological Quality & Sterility Assurance (JJMQSA) group based in Raritan, NJ.

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

With $81.6 billion in 2018 sales, Johnson & Johnson 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 markets. There are more than 250 Johnson & Johnson operating companies employing over 130,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

The Principal Scientist, Aseptic Processing leads E2E implementation of aseptic processing policies and strategies for JJMQSA and directs and supports aseptic processing best practices and compliance across the enterprise.
• Serves as a global technical leader in the areas of aseptic processing with responsibility to support all J&J companies including CMO partners worldwide with technical competency and resourcing gaps.
• Acts as a leader for new technologies and new aseptic applications such as ATMPs, work on development of specification setting and standards for these new applications
• Contribute to ongoing scientific debate on advancing conventional sterility definition towards Microbiological Quality definition
• Leads compliance and risk-based evaluations and provides in-depth technical support for new aseptically manufactured products including technology concepts, process development and validation activities.
• Drives the groups and company’s strategic and tactical directions and financial results through the application of technical knowledge and expertise in aseptic processing.
• Delivers as a leader in the MQSA-Raritan AP group to deliver the groups G&Os and deliver results on time and within budget
• External Influencing – actively networks with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge including representing the corporation at industry and standards associations (e.g., ASTM, ISO, AAMI), influencing regulations and standards that allows for the opportunity to develop next generation of J&J MQSA employees.

R&D
• Conducts research in problem areas of increasing scope and complexity and approaches problems through a series of complete and conceptually related studies, which may include existing or novel approaches and research techniques.
• Collaboration with various groups (R&D, Q&C, and Regulatory Affairs) on product and packaging development, clinical evaluation, product/process validation.
• Leads the development of new innovative test methods, innovative tools for data analysis and practices in the areas of aseptic processing, Work on methodology enabling Real-time Release Testing for aseptically manufactured products.
• Leads and directs strategic projects with the horizontal and vertical JJMQSA peers to find break-through technologies in aseptic processing and aseptic technique applications.
• Work directly with the project leaders as the technical SME to define product and process needs for aseptically manufactured products including the validation of those needs (as needed)

Plan
• Supports operating company affiliates in maintaining regulatory readiness and due diligence of potential acquisitions.
• Supports the selection and assessment of new manufacturing operations (to include contract manufacturing & laboratories) as it relates to E2E sterility assurance focused on aseptic manufacturing

Source
• Acts as a technical SME for due diligence of aseptically manufactured products, and provide technical and business leadership for integration into J&J
• Acts as a technical SME in support for procurement activities that relate to aseptically manufactured products that are externally manufactured

Make
• Leads and directs activities to the extended MQSA teams in the IQ, OQ and PQ of equipment and controlled manufacturing environments (CME’s) used to aseptically manufacture healthcare and consumer products.
• Provides technical leadership, when required, to operating companies in gap analysis and root cause investigation of routine process failures, training and consultation as well as in assessing and improving regulatory inspection readiness.
• Provides technical leadership, when required, for aseptically manufactured products or components at internal or external manufacturing sites.
• Proposes technical leadership to the organization to resolve difficult problems and address knowledge and/or resource gaps.

Deliver
• Drives aseptic processing compliance with industry standards and regulatory requirements including safety and security

External influencing
• Actively leads within the external scientific, technical and regulatory community to maintain state of the art knowledge and processes.
• Represents the corporation through strategic leadership positions at industry and standards associations (e.g. ASTM, ISO, AAMI etc.) influencing regulations and standards.

Internal Influencing
• Actively leads within the internal scientific, technical and regulatory community to maintain state of the art knowledge and processes.
• Develops and delivers programs to develop/train/maintain aseptic processing competencies across the corporation for new hires, as well as current/next generation MQSA talent to ensure understanding and compliance with Corporate and regulatory standards.
• Serves as the technical SME for the enterprise Standards associated with aseptic processing
• Serves as a member on the J&J Aseptic Processing Council
 

Qualifications
• Bachelors’ degree required. Degree concentration in Pharmaceutics, Life-Sciences, Microbiology or related fields are preferred.
• A minimum of 10 years related experience required.
• Recognized as subject matter expert in the areas of aseptic processing and pharmaceutical manufacturing and/or medical device manufacturing and has made significant achievements in area(s) of aseptic processing preferred.
• Extensive working knowledge of the aseptic manufacturing of healthcare (medical device and pharmaceuticals) and consumer products including controlled manufacturing environments / clean rooms, Restricted Access Barrier Systems (RABS) and isolators required.
• Advanced therapy medicinal products (ATMP) knowledge and/or experience preferred.
• Hands on expertise with the validation and qualification of equipment associated with the aseptic manufacturing process including moist heat and vapor hydrogen peroxide (VHP) sterilization and decontamination required.
• Hands on expertise with environmental controls and container closure systems including trending and failure investigation required.
• Knowledgeable in quality system activities and QA compliance for control strategies, change control, non-conformance, investigation, calibration, preventative maintenance, data analysis, and documentation required.
• Leverages a high-level knowledge of industry standards and experience in interacting with Regulatory Authorities required.
• Authoring and/or presenting publications preferred.
• The individual will be a self-starting results-oriented leader with the ability to work independently as well as lead a technical team.
• Excellent written and verbal communication skills. Ability to work in a matrix environment, with senior level management, and ability to influence and present sensitive information to all levels of the organization is required.
• Effective time management skills to allow for multi-tasking of responsibilities.
• Travel: This position will require up to 50% travel domestic and international.

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.

Primary Location
United States-New Jersey-Raritan-
Organization
Johnson & Johnson International (6078)
Job Function
R&D
Requisition ID
3648191021