Johnson & Johnson is currently seeking a Principal Scientist - Microbiologist (Quality) to join our Johnson & Johnson Innovative Medicine Supply Chain organization located in Wilson, North Carolina.

While this role will ultimately support the site operations located in Wilson NC, this role will also be required to support the project phase across both design & construction. For the project design phase, the role will require you to be present with our design teams in the Greater Philadelphia region. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site in Wilson, NC. Based on your current location the hiring team will work with you to determine travel and relocation arrangements. In steady state, we expect travel to be less than 10%.

• Provide quality and microbiological oversight and guidance to the detailed design, construction and qualification phases of the new facility ensuring best practices, corporate standards and regulatory guidance are taken into consideration.
  • Ensure facility design takes into consideration the ISO classifications of the areas where appropriate and develop the microbial classification strategy for the production facility.
  • Ensure facility design takes into consideration viral segregation and multi product manufacturing.
  • Mentor and coach QC and Operations Microbiologist (s) to facilitate smooth transitions from construction to operational phases, forming partnerships and cross-functional teams to support the new site's successful startup and routine operations.
• Develop, implement, and oversee a Microbiological Control Strategy, ensuring compliance with corporate standards, cGMP, EHS, and other regulatory requirements across all site activities. This includes but is not limited to:
  • Setting up utilities monitoring (WFI, CS, Process Gas) and routine environmental monitoring programs in collaboration with the QC and Operations teams.
  • Support implementation of training programs, as needed, with oversight for the Aseptic Technique and Microbiological Control training programs for people accessing the manufacturing areas.
  • Support development of SOPs, WIs and roll out of training as required to support operational and microbiological area readiness.
• Support site/product investigations as required. In conjunction with the QC Micro Team Leader identify, record and resolve any microbiology related product issues leading to nonconformances
• Provide guidance across Operations and QC areas to enhance knowledge and best practices in line with the latest available technologies.
• Cultivate a culture of continuous improvement and open communication to maintain high aseptic awareness and compliance standards.
• Encourage the development and implementation of innovative technologies and methodologies to enhance next-generation manufacturing capabilities.
• Assist in operational readiness for both the quality and operations teams.
• Develop the multi product strategy for the site in conjunction with Operations providing Quality and Micro oversight. Ensure multi product risk assessments are in place to proactively identify weaknesses and implement mitigations.
• Formulate strategies for new and critical technologies to support real-time release and integrated quality initiatives, where feasible.
• Ensure the integration of process parameter requirements with MES/electronic batch records to meet all regulatory, compliance, and monitoring documentation needs in manufacturing.
• Contribute to drafting and reviewing regulatory submissions and responses to regulatory agencies.
• Assist in determining the insourcing/outsourcing strategy for key activities within the area of expertise.

• Bachelor's degree in a Microbiology/Biology or scientific discipline is required.
• Minimum of 4 years' experience working within the biological and/or pharmaceutical industry.
• Strong knowledge in a wide variety of microbiological/analytical techniques/methods and associated equipment including but not limited to sterility testing, bioburden and endotoxin techniques, autoclave, environmental and utilities testing, and gamma irradiation.
• Strong knowledge and understanding of relevant regulations and quality management principles, such as Good Manufacturing Practices (GMP), ICH, FDA guidelines, and ISO standards in a biological or pharmaceutical manufacturing environment.
• Strong analytical and problem-solving skills, with a track record in leading investigations and implementing effective CAPAs.

• An unquestionable level of integrity and commitment to operating ethically and within the boundaries of regulatory requirements.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex quality concepts to stakeholders at all levels.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• Detail-oriented mindset, with a keen eye for identifying opportunities for process improvements.
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
• Ability to build and nurture strong and positive relationships.
• The ability to work in a team environment and interact with all levels of the organization.
• Results-driven leader who commits to stretch goals and delivers results.

• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year