Senior Scientist Manufacturing– MSAT

Johnson & Johnson Innovative Medicine is recruiting for a Senior Manufacturing Scientist – Local MSAT (LCM), located in Leiden.

Are you passionate about driving innovation in biopharmaceutical manufacturing? Join our Site MSAT team in Leiden and play a pivotal role in crafting the life cycle strategy of commercial drug substance products.

In this senior MSAT LCM role, you will serve as technical lead for products, owning Life Cycle Management (LCM) execution and Continued Process Verification (CPV) performance to maintain and improve production processes in their validated state.

You will partner closely with Manufacturing, Quality (QA/QC), Regulatory, and Global MSAT to drive robust control strategies, lead sophisticated investigations and change controls, and deliver continuous improvement and innovation—ultimately helping ensure reliable supply of life‑saving medicines.

Key Responsibilities:

• Be the person for products, accountable for LCM execution and CPV performance; introduce, maintain, and improve processes while preserving validated state.
• Define study approach and collaborate with cross‑functional SMEs to complete studies optimally; write technical memos with minimal review and stay current on scientific developments.
• Lead and facilitate sophisticated investigations (including NC/CAPA) and risk assessments (e.g., FMEA, HACCP); define control‑strategy updates and recommend risk mitigations.
• Own and assess process‑related change controls and document impact on Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs) and Critical Material Attributes (CMAs).
• Lead Process Technical Review meetings to assess process performance and define recommendations addressing risk, trends, and improvement opportunities.
• Be responsible for the CPV program and alert management; define metrics and blocking issue pathways and lead investigations on statistically significant CPV shifts, trends, and excursions.
• Support and lead regulatory‑facing activities: prepare for and participate in audits/inspections; chip in to post‑approval submissions and responses to Health Authority questions within area of expertise.
• Provide SME support for introduction of new equipment/materials (e.g., URS, CARA) and for technology transfer/scale‑up activities.
• Use relevant data systems to compile, analyze, and visualize process data; apply sophisticated statistics/DoE where appropriate.
• Mentor and guide team members; actively supply to Communities of Practice (CoPs), technical groups and forums and cultivate a culture of belonging through inclusive collaboration.

Qualifications

Education:

• MSc (or PhD) in (Bio)Chemical Engineering, Biotechnology, or related field.

Experience and Skills:

Required:

• 5–8+ years confirmed experience in MSAT/LCM in a GMP environment with deep expertise in drug substance upstream and/or downstream processes.
• Solid understanding of end‑to‑end biological manufacturing processes, including process equipment and supplies.
• Shown experience leading investigations and owning change controls, including assessment of impact on CQAs/CPPs/CMAs.
• Advanced statistics / Design of Experiments (DoE) and data analytics capability; confident use of data systems for analysis and visualization.
• Excellent technical writing and stakeholder management; able to communicate optimally in both technical and business terms and influence across functions.
• Experience supporting audits/inspections and regulatory submissions; awareness of key regulatory agencies and applicable industry expectations.
• Proven integrity, independent judgment, accuracy/quality attitude, and ability to prioritize work in a multifaceted environment.
  

Preferred:

• Experience driving digitalization initiatives and/or introducing new technologies at a manufacturing site.
• Familiarity with integration of global standards into local production processes.
• Six Sigma or similar continuous improvement certification (preferred).
• Experience with argument development and participation in project prioritization exercises.
• Experience developing process‑specific training programs or mentoring/coaching others.
  

Other:

• Language: English proficiency (B2 level) required; Dutch is a plus.
• Travel: Occasional, as business needs (exact percentage to be confirmed).

Preferred Skills:

Agile Decision Making, Coaching, Corrective and Preventive Action (CAPA), Critical Thinking, Emerging Technologies, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Product Costing, Product Improvements, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy, Validation Testing, Vendor Selection

Hybrid Wo