Senior DP Biologics Engineer​/Scientist

Job Function

Supply Chain Engineering

Process Engineering

Scientific/Technology

Malvern, Pennsylvania, United States of America;
Titusville, New Jersey, United States of America

• Represents MSAT and the technical team in the Value Chain Team (VCT) and provides the required manufacturing technical support
• Provide onsite technical support and guidance to CMOs during Tech Transfers and/or Deviation resolutions, representing the MSAT voice
• Serve as the SME and single point of accountability for DP technical aspects across the product lifecycle
• Define and drive the technical lifecycle management strategy, including process robustness, performance monitoring, and continuous improvement
• Supports the VCT to identify improvement/innovation opportunities, to build project business cases and to prioritize projects (product related)
• Owns the coordination of all product-related technical activities
• Monitors technical process and product performance
• Identifies and implements opportunities for active decrease in manufacturing COG’s
• Implements or follows-up on execution of technical projects
• Deploys the platform standardization policy as appropriate
• Supports failure investigations (escalation of quality or compliance events)
• Reviews technical product & process risk profile and criticality analysis
• Implementing and supporting new platforms innovations or changes in life cycle management products
• Provides this expertise as well to External Manufacturing related to the Biotherapeutics Platform
• The successful candidate will be an integer person with a high level of self-awareness and adaptability
• Proven leadership in providing integration of activities and information across multifunctional groups and matrix teams
• Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams
• Ability to influence peers, superiors, and partners
• Understands culture differences

• Education:
  
  A minimum of a bachelor’s degree (Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, (biological) Engineering; Life Science Technology) or equivalent required;
  Master’s degree in Science or Engineering preferred
• Experience And Skills:
  • 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 data into clear, actionable insights for senior stakeholders and cross‑functional teams
  • Advanced proficiency in data analysis, problem‑solving, and digital tools (beyond MS Office), with a focus on data‑driven decision‑making and continuous improvement
  • Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
• Preferred:
  • Proven ability to collaborate and drive outcomes within global, cross‑functional, and highly matrixed team environments
• Other:
  • Ability to travel as needed to maintain a strong on‑site MSAT presence at J&J and CMO partner sites (North…