Scientific Senior Manager, Particulates Analytical Development

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

We are offering an outstanding opportunity for a

• →Provide scientific and strategic leadership for particulate matter analytics

• →Define phase-appropriate analytical strategies for visible and subvisible particulate matter and ensure alignment with product development needs, internal standards, and global health authority expectations

·         Lead and oversee method development, qualification, validation, transfer, investigation, and lifecycle activities for particulate matter assays, including planning, execution, documentation, and review

• →Serve as SME for particulate analytics in cross-functional teams and provide scientifically sound recommendations for technical issues

• →Author and critically review high-quality technical and regulatory documents, including analytical transfer reports, validation documentation, responses to health authority questions, and relevant sections of global regulatory submissions

• →Interpret and integrate complex analytical data into clear scientific conclusions, risk assessments, and regulatory strategies

• →Coordinate project deliverables, timelines, and interfaces with R&D, manufacturing sites, commercial quality control laboratories, and other external partners

·         Identify opportunities to strengthen particulate matter analytics capabilities, improve business processes, and evaluate emerging and innovative technologies to ensure the future-oriented development and sustainability of the analytical portfolio

• →Support particle-counting analytical procedures for cell and gene therapy products

• →Provide analytical support to QC laboratories, investigations, complaint testing, and site-support activities

• →Oversee the AD BSL-2 laboratory, including responsibility for training and compliant laboratory operations

For this position, we are looking for an experienced, scientifically curious, flexible, and team-oriented professional ideally with leadership experience with excellent communication and problem-solving skills, as well as the following qualifications:

• Master’s degree with at least 10 years of relevant industry experience, or PhD with a minimum of 7 years of relevant experience, in life science, engineering, analytical sciences, pharmaceutical sciences, or a related discipline

• Demonstrated experience in analytical method development, qualification, validation, or transfer for particle counting methods

• Demonstrated experience in authoring and reviewing technical content for regulatory submissions is required, including the ability to translate complex analytical data into clear, concise, and scientifically defensible regulatory narratives

• Strong record of technical writing and scientific presentation

• Excellent analytical and problem-solving skills, including the ability to identify gaps and root causes and develop practical, innovative solutions

• Ability to work independently, prioritize effectively, meet tight deadlines, and maintain a constructive attitude

• Demonstrated ability to lead complex, cross-functional teams, capability and commitment to developing a team-oriented, diverse, inclusive, and Credo-driven culture

• Scientific curiosity, a continuous-improvement mindset, and the determination to challenge the status quo responsibly
  
  “A pre-identified candidate for consideration has been identified. However, all applications will be considered”