Senior Dp Biologics Engineer/scientist

Johnson & Johnson Johnson & Johnson · Pharma · Titusville, NJ +2

Johnson & Johnson is seeking a Senior DP Biologics Engineer/Scientist to serve as the end-to-end scientific and technical authority for a designated drug product or portfolio. This role involves leading the technical strategy, lifecycle management, and continuous improvement of commercial drug product processes, ensuring compliance, robustness, and supply reliability. Responsibilities include providing technical support to internal and external manufacturing networks, representing MSAT in Value Chain Teams, and driving process improvements and COGs reduction within a GMP-regulated environment.

What you'd actually do

  1. Represents MSAT and the technical team in the Value Chain Team (VCT) and provides the required manufacturing technical support
  2. Provide onsite technical support and guidance to CMOs during Tech Transfers and/or Deviation resolutions, representing the MSAT voice
  3. Serve as the SME and single point of accountability for DP technical aspects across the product lifecycle
  4. Define and drive the technical lifecycle management strategy, including process robustness, performance monitoring, and continuous improvement
  5. Supports the VCT to identify improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)

Skills

Required

  • Minimum 5 years of progressive experience in sterile/aseptic biologics drug product manufacturing within a GMP-regulated environment, or Process Development/Research or Tech Transfer Experience
  • Scientific background in engineering or life sciences (or similar) or experience in the respective field.
  • Proven ability to lead and influence cross-functional, matrixed teams across MSAT, Manufacturing, Quality, Regulatory, and Supply Chain with a high degree of autonomy and ownership
  • Ability to provide technical leadership for post-approval changes, tech transfers, validation activities, and process improvements
  • Deep understanding of GMP, regulatory expectations, and lifecycle management frameworks
  • Experience with process performance monitoring and Continued Process Verification (CPV), including data trending, statistical analysis, and identification of improvement opportunities
  • Demonstrated ability to apply science-based, risk management tools (e.g., FMEA, risk assessments) to support robust decision-making and regulatory compliance
  • Strong business acumen with experience identifying and delivering COGs reduction, process efficiency, and standardization initiatives
  • Excellent written and verbal communication skills with the ability to translate complex technical da

Nice to have

  • Master’s degree in Science or Engineering preferred

What the JD emphasized

  • GMP-regulated environment
  • process robustness
  • continuous improvement
  • lifecycle management