Senior Specialist – Tech Transfer & Manufacturing Science (SBX Sequencing) responsible for the key technical anchor of advanced genetic sequencing workflows at Roche Diagnostics International AG in Rotkreuz. The role involves technical transfer, process optimization, regulatory compliance, and cross‑functional collaboration across our dual‑site strategy between Switzerland and the United States. Key Responsibilities
Technology Transfer & Site Alignment: Drive the technical transfer of RUO (Research Use Only) and regulated genetic sequencing workflows (SBX sequencing chemistry) from Roche Santa Clara, USA, to the Rotkreuz site, ensuring absolute process alignment. Subject Matter Expert (SME): Serve as the primary technical authority for drafting, reviewing, and auditing site‑specific operating procedures, batch record templates, and work instructions for critical consumable components. Process Optimization & Scaling: Manage and execute complex experiments throughout the product lifecycle, from initial feasibility and stability testing through to official launch and routine manufacturing transfer. Advanced Quality Control: Oversee high‑priority investigations into complex process failures or manufacturing deviations, applying advanced statistical techniques and data analysis to implement robust Corrective and Preventive Actions (CAPA). Cross‑Functional Training: Translate development workflows into standardized work procedures, providing deep technical guidance and training local operators on complex reagent handling, raw material formulation, automated dispensing, and data analyzation. End‑to‑End Quality Inspection: Act as the final technical gatekeeper for complex diagnostic portfolios, ensuring strict adherence to compliance standards, including final inspections of specialized testing frameworks. Qualifications
Regulated Industry Expert: Seasoned scientist with comprehensive experience driving operations within strict cGMP, ISO 13485, and QSR‑compliant biotech and molecular diagnostics environments. End‑to‑End Quality Mindset: Proven track record in executing rigorous in‑process quality control (QC), raw material stability testing, and final product inspections to ensure total regulatory compliance. Analytical Problem Solver: Highly skilled in managing nonconformances and deviations, utilizing data‑driven root‑cause analysis to implement effective corrective and preventive actions (CAPA). Process & Efficiency Optimizer: Demonstrated success in process improvement and technology transfer projects, with a history of leveraging ERP systems (SAP) to measurably reduce production timelines and costs. Documentation & Compliance Anchor: Expert in the end‑to‑end lifecycle of critical manufacturing documentation, including drafting, cross‑functional review, and approval of batch records and SOPs. Adaptable Technical Skills: Proficient in both high‑precision manual laboratory techniques and the operation, maintenance, and troubleshooting of high‑throughput automated instrumentation. Cross‑Functional Collaborator: Adept at bridging gaps between R&D, Quality Assurance, and Engineering teams to ensure seamless internal product transfers and hit aggressive deadlines. Workflow Coordination & Mentorship: Experienced in synchronizing cross‑functional workflows, overseeing production lines, and designing training schedules to upskill team members on GMP compliance. Benefits
18 weeks of maternity leave 10 weeks of gender‑independent partnership leave Flexible working options On‑site childcare facilities Medical services Restaurants, cafeterias, and various employee events Take the next step in a career that builds the future of global diagnostics. Roche is an Equal Opportunity Employer.
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Technology Transfer & Site Alignment: Drive the technical transfer of RUO (Research Use Only) and regulated genetic sequencing workflows (SBX sequencing chemistry) from Roche Santa Clara, USA, to the Rotkreuz site, ensuring absolute process alignment. Subject Matter Expert (SME): Serve as the primary technical authority for drafting, reviewing, and auditing site‑specific operating procedures, batch record templates, and work instructions for critical consumable components. Process Optimization & Scaling: Manage and execute complex experiments throughout the product lifecycle, from initial feasibility and stability testing through to official launch and routine manufacturing transfer. Advanced Quality Control: Oversee high‑priority investigations into complex process failures or manufacturing deviations, applying advanced statistical techniques and data analysis to implement robust Corrective and Preventive Actions (CAPA). Cross‑Functional Training: Translate development workflows into standardized work procedures, providing deep technical guidance and training local operators on complex reagent handling, raw material formulation, automated dispensing, and data analyzation. End‑to‑End Quality Inspection: Act as the final technical gatekeeper for complex diagnostic portfolios, ensuring strict adherence to compliance standards, including final inspections of specialized testing frameworks. Qualifications
Regulated Industry Expert: Seasoned scientist with comprehensive experience driving operations within strict cGMP, ISO 13485, and QSR‑compliant biotech and molecular diagnostics environments. End‑to‑End Quality Mindset: Proven track record in executing rigorous in‑process quality control (QC), raw material stability testing, and final product inspections to ensure total regulatory compliance. Analytical Problem Solver: Highly skilled in managing nonconformances and deviations, utilizing data‑driven root‑cause analysis to implement effective corrective and preventive actions (CAPA). Process & Efficiency Optimizer: Demonstrated success in process improvement and technology transfer projects, with a history of leveraging ERP systems (SAP) to measurably reduce production timelines and costs. Documentation & Compliance Anchor: Expert in the end‑to‑end lifecycle of critical manufacturing documentation, including drafting, cross‑functional review, and approval of batch records and SOPs. Adaptable Technical Skills: Proficient in both high‑precision manual laboratory techniques and the operation, maintenance, and troubleshooting of high‑throughput automated instrumentation. Cross‑Functional Collaborator: Adept at bridging gaps between R&D, Quality Assurance, and Engineering teams to ensure seamless internal product transfers and hit aggressive deadlines. Workflow Coordination & Mentorship: Experienced in synchronizing cross‑functional workflows, overseeing production lines, and designing training schedules to upskill team members on GMP compliance. Benefits
18 weeks of maternity leave 10 weeks of gender‑independent partnership leave Flexible working options On‑site childcare facilities Medical services Restaurants, cafeterias, and various employee events Take the next step in a career that builds the future of global diagnostics. Roche is an Equal Opportunity Employer.
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