Sr Laboratory Large Molecule Drug Product Process Scientist

Johnson & Johnson seeks a Senior Laboratory Large Molecule Drug Product Process Scientist in Schaffhausen to lead process optimization and lifecycle management for parenteral products.

This position operates within the MSAT global department, focusing on the life cycle management and process optimization of large-molecule parenteral products. The scientist is responsible for executing process development studies, supporting technology transfer activities, analyzing process data, and facilitating the implementation of PAT and digital tools to support Annex 1 compliance.

Responsibilities

• Draft, evaluate, and authorize technical protocols, reports, and product impact assessments for lifecycle management and secondary technology transfer.
• Refine lab-scale models to assess process parameters, then translate these insights to scale-up efforts to confirm or adjust critical and key parameters.
• Examine process data to identify data-driven changes for secondary technology transfer or lifecycle management initiatives.
• Design and conduct lab-based process development studies on products to inform lifecycle decisions regarding unit operations such as freeze/thaw, mixing, filtration, and filling.
• Manage filter validation projects in collaboration with external partners.
• Assist in the integration of new technologies, PAT, and digital tools into commercial processes.
• Maintain strict adherence to GMP and ICH standards while ensuring comprehensive documentation.
• Work closely with global cross-functional teams and the commercial supply chain to analyze process performance data and drive improvements.
• Establish the lifecycle management function by implementing tools, processes, and training to streamline scale-up and support technology transfer.
• Provide support for process modeling and statistical data analysis.
• Participate in best practice initiatives designed to enhance the efficiency and effectiveness of process development.

Requirements

• MSc or PhD in Pharmacy, Chemical Engineering, Biotechnology, or a related field.
• Minimum of five years of experience in MSAT, lifecycle management, or technology transfer within the pharmaceutical or biotech industry.
• Proven hands-on experience in conducting lab studies and process validations with external vendors or contract manufacturing organizations.
• Proficiency in data evaluation using tools such as JMP, Minitab, or Excel.
• Experience working in GXP environments within pharmaceutical production and laboratories.
• Familiarity with GMP/ICH regulations and systems like LIMS, MES, or SAP, along with strong stakeholder management skills.
• Fluency in English.

Nice to have

• German language skills.

About the company

Johnson & Johnson maintains a global workforce and is committed to its employees. The company fosters an inclusive environment that treats every individual with respect, recognizing diversity, dignity, and merit.

• The company is responsible to its employees worldwide.
• An inclusive work environment is provided where each person is valued as an individual.
• Diversity and dignity are respected, and employee merit is recognized.