Senior DP Biologics Engineer​/Scientist

Responsibilities

• 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

• Education: Minimum bachelor’s degree in Biomedical, Biochemical, Chemical Technology, Biotechnology, Pharmacy, (biological) Engineering;
  Life Science Technology or equivalent. Master’s degree in Science or Engineering preferred.
• Experience &
  
  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.
• Ability to travel as needed to maintain a strong on‑site MSAT presence at J&J and CMO partner sites (North Carolina and Indiana), with flexibility to respond to short‑notice, time‑critical technical and project demands.

The anticipated base pay range for this position is : $94,000.00 - $

• Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Long‑term incentive program.
• Vacation – 120 hours per calendar year.
• Sick time – 40 hours per calendar year (48 for Colorado, 56 for Washington).
• Holiday pay, including Floating Holidays – 13 days per calendar year.
• Work, Personal and Family Time – up to 40 hours per calendar year.
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
• Bereavement Leave – 240 hours for an immediate family…