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%.

J& J is expanding our manufacturing capacity with $2 billion investment to support strongportfolio growth and continue delivering breakthrough innovation and transformational medicinesfor patients. The new facility will expand production of innovative biologic medicines in areas including oncology, immunology, and neuroscience. J& J's significant supply chain investment ensures a resilient and reliable future supply of medicines to meet accelerating demand for our current portfolio of medicines and our future innovations.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, andsolutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

We are currently seeking a highly qualified individual to join our QC team as a Principal Scientist - Microbiologist at our new Large Molecule Drug Substance Manufacturing facility. In this key role, you will be responsible for ensuring that all aspects which may concern the microbial quality of the product, such as process validation, cleaning validation, method validation/transfer, environmental monitoring, critical site utilities & services, aseptic manufacture are executed appropriately.

Essential Job Duties and Responsibilities:

• 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.

Qualifications

Required:

• 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.

Preferred:

• 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.

Note: This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.

If you are passionate about quality/microbiological position in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a Principal Scientist - Microbiologist. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment.

The anticipated base pay range for this position is $91, 000 to $147, 200. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on 12/31/2024. The Company may however extend this time-period, in which case the posting will remain available on https: //www.careers.jnj.com to accept additional applications.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

• 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

For additional general information on Company benefits, please go to: https: //www.careers.jnj.com/employee-benefits

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .