Sr Laboratory Large Molecule Drug Product Process Scientist

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Summary:

This role supports life cycle management (LCM) and process optimization for largemolecule parenteral products within MSAT global department. Execution of process development studies and supportive techtransfer tasks analyzes process data aids PAT/digital tool rollout and support Annex1 process changes. Ensures GMP/ICH compliance and collaborates with crossfunctional and external partners.

Key Responsibilities

• Prepare review and approve technical protocols reports and product impact assessments related to product lifecycle management (LCM) and 2nd TT.
• Apply and improve lab-scale models to evaluate process parameters and ranges; translate findings to scale up and confirm or adjust critical/key parameters
• Analyze process data and access data driven changes for 2nd TT or LCM activities
• Plan and execute process development studies in the lab on product to support lifecycle decisions for unit operation (freeze/thaw mixing filtration filling)
• Lead filter validation activities with external partners
• Support new technology PAT and digital tool implementation to commercial processes
• Ensure GMP/ICH compliance; document
• Collaborate globally with cross functional teams and commercial supply chain to review process performance data in depth and drive process improvements
• Enable MSAT digital capabilities and establish the LCM function by implementing tools processes and training to streamline scaleup and support techtransfer and process changes.

Other Responsibilities

• Opportunity to develop process engineering skills and data analysis
• Support the department information technology and building up the LCM department
• Support process modeling and the statistical analysis of data.
• Contributes to best practice initiatives aimed at streamlining process development processes to enhance efficiency and effectiveness.

Required Qualifications

• MSc/PhD in Pharmacy Chemical Engineering Biotechnology or related; 5 years in MSAT/LCM/Tech Transfer in pharma/biotech
• Strong handson experience executing lab studies and process validations with external vendors/CMOs
• Skills on dataevaluation using tools (e.g. JMP Minitab Excel).
• GXP experience in Pharma production and Laboratory
• Familiarity with GMP/ICH and systems like LIMS/MES/SAP; strong stakeholder management.
• Proficient in English; German language skills are optional.
• Creative flexible and open-minded
• Familiarity with GMP/ICH and systems like LIMS/MES/SAP; strong stakeholder management.

Location:

This role requires a minimum of 3 days a week onsite presence at the JNJ Schaffhausen site. More days onsite per week may be required depending on Lab study execution. Flexibility is expected to ensure timely study execution in the Labs.

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