Senior Scientist Manufacturing– MSAT

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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 innovationultimately helping ensure reliable supply of lifesaving 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 crossfunctional 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 controlstrategy updates and recommend risk mitigations.

• Own and assess processrelated 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 regulatoryfacing activities: prepare for and participate in audits/inspections; chip in to postapproval 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/scaleup 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:

• 58 years confirmed experience in MSAT/LCM in a GMP environment with deep expertise in drug substance upstream and/or downstream processes.

• Solid understanding of endtoend 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 processspecific 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).

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Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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