MSAT Manufacturing Scientist

MSAT Manufacturing Scientist, Drug Substance

Location: Leiden, Netherlands

Duration: 12 months

Hours: 40 hours per week, regular hours

Are you passionate about ensuring life-saving medicines are produced with the highest quality and efficiency? As our team member (Manufacturing Scientist), you’ll play a critical role in keeping commercial pharmaceutical processes robust, efficient, and in control. In this position, you will be a hands-on technical leader at the interface of science and manufacturing, working in a Good Manufacturing Practices (GMP) environment. Your contributions will directly impact patient health by supporting the reliable supply of high-quality biopharmaceutical products.

roles and responsibilities

• Provide Scientific & Technical Support: Oversee and support commercial drug substance manufacturing processes to ensure they remain robust, efficient, and fully compliant with GMP standards throughout the product’s life cycle.

• Investigate and Resolve Production Issues: Lead and support thorough root-cause investigations for manufacturing deviations or non-conformances, determine product impact, and drive effective corrective and preventive actions to avoid recurrence.

• Maintain Validated Process State: Author and update technical documentation—including process protocols, reports, and change control justifications—ensuring processes stay in a validated state and meet all regulatory and quality requirements.

• Monitor Process Performance: Analyze manufacturing data and trends as part of ongoing process monitoring (continued process verification) to identify shifts or deviations early, and recommend appropriate adjustments to maintain consistent product quality and yield.

• Implement Process Improvements: Identify opportunities for process optimization and innovation, such as introducing new equipment or materials and updating process control strategies. Develop and execute improvement plans in collaboration with cross-functional partners, ensuring any changes are scientifically sound and properly qualified.

• Cross-Functional Collaboration: Partner closely with Manufacturing, Quality (QA/QC), Engineering, and Regulatory teams to troubleshoot issues, align on solutions, and ensure seamless implementation of changes and improvements.

What You Will Deliver (Key Deliverables):

• Comprehensive investigation reports that pinpoint root causes of manufacturing issues and outline robust corrective action plans to enhance process reliability.

• Regular process performance summaries (ongoing monitoring reports) that highlight trends, control limits, and opportunities for preventive action to ensure consistent product quality.

• Clear change impact assessments for proposed process or equipment changes, evaluating potential effects on product quality and validated state, with well-justified recommendations.

• Detailed technical study protocols and reports for manufacturing process experiments or improvements, documenting methods, results, and conclusions for internal review and audit readiness

how to succeed

Qualifications:

• Education: Master’s degree in Biotechnology, Chemical/Bioprocess Engineering, Biochemistry, or a related field (advanced degree preferred).

• Experience: Proven experience (typically 3-6+ years) in pharmaceutical or biopharmaceutical manufacturing within a GMP-regulated commercial production environment. Experience can include roles in manufacturing science & technology, process engineering, or related technical support functions.

• Required Skills and Competencies: 

  • Strong understanding of manufacturing processes (such as cell culture, fermentation or purification) and associated equipment in a pharmaceutical or biotechnology setting.

  • Hands-on experience with process troubleshooting and root cause analysis, including leading or contributing to investigations of production issues and implementing effective solutions.

  • Demonstrated ability to author high-quality technical documents (e.g. protocols, reports, risk assessments, or change control documentation) with clarity and attention to detail.

  • Proficiency in analyzing process data (using tools or statistical methods) to monitor process performance and support data-driven decisions for process control and improvements.

  • Excellent knowledge of Good Manufacturing Practices (GMP) and a strong quality and compliance mindset.

  • Effective communication and collaboration skills, with the ability to work cross-functionally and clearly convey complex technical information to different stakeholders.

  • Problem-solving orientation and continuous improvement mindset—proactive in identifying opportunities to enhance process robustness, efficiency, and product quality.

• Preferred (Additional) Qualifications: 

  • Advanced degree (PhD) in a relevant discipline.

  • Direct experience with biologics drug substance manufacturing (upstream cell culture and/or downstream purification processes).

  • Experience leading complex process improvements or technology introduction projects in a manufacturing environment (e.g. implementing new equipment, new process technologies, or process scale-up).

  • Familiarity with formal risk assessment tools (such as FMEA) and statistical techniques (e.g. design of experiments) for process optimization.

Other:

• Language: Proficiency in English (written and spoken) is required.

• Travel: This position is based at our manufacturing site in Leiden

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 month duration. This is a hybrid position, 3 days on-site, 2 days at home.

you are welcome here

J&J is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email.. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.