Director, Analytical Instruments
Scorpion Therapeutics, San Francisco, California, United States, 94199
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Role Summary
Director, Analytical Instruments leads instrument control and data acquisition management for complex analytical instruments within Quality Control, supporting both small molecule and biologics. The role oversees implementation, qualification, ongoing operations, enhancements, decommissioning, and retirement of these instruments and their control software, ensuring regulatory compliance and data integrity. It drives automation of laboratory processes, champions emerging technologies including AI, and partners with Quality leadership, Technical Development, IT, Manufacturing, CMC Regulatory, Finance, and Procurement to enable data‑driven, digitally empowered workflows. The position is based in Foster City, CA. Responsibilities
Apply knowledge of analytical instrumentation and software across chromatography, microplate readers, mass spectrometry, endotoxin testing, titration, particle size analysis, Mettler‑Toledo instrument data acquisition, X‑ray diffraction, thermal analysis, nuclear magnetic resonance, optical rotation, infrared spectroscopy, and disintegration. Understand USP 1058, Analytical Instrument Qualification and its application. Responsible for instrument control and data acquisition software such as Waters Empower, Mettler‑Toledo LabX, Softmax Pro, MassHunter, OMNIC Paradigm, OPUS, TRIOS, and Tiamo. Maintain quality and compliance of instruments including data integrity, GMP adherence, and right‑first‑time execution. Lead business case development and ROI analysis for new complex instrument investments, effectively communicating trade‑offs between speed, cost, and scope to leadership and stakeholders. Critically analyze the instrument landscape, processes, metrics, pain points, and opportunities for improvement with GMP compliance, program delivery, vendor coordination, and inspection readiness. Deliver GMP analytical instruments and associated instrument control software to quality laboratories in a timely manner, with documentation, qualification, and processes meeting their intended use. Ensure instruments are highly available for testing by scientists and remain in a compliant state. Foster relationships with major instrument vendors such as Waters, ThermoFisher, Agilent, and Mettler Toledo. Continuously refine quality operations strategy and roadmaps aligned to organizational priorities and enterprise platforms. Maintain quality records for complex instrument deviations, change controls, CAPA actions, and ensure timely closure and resolution. Represent management and compliance of complex instruments during inspections. Communicate utilization, reliability, maintenance, and inventory information to leadership and stakeholders. Lead innovation and continuous improvement initiatives to optimize instrument management and lab workflows. Qualifications
Required: Bachelor's Degree and Twelve Years’ Experience; OR Masters’ Degree and Ten Years’ Experience; OR PhD and Eight Years’ Experience. Preferred: Hands‑on laboratory experience and analytical instrument use. Preferred: At least 5 years in a leadership role managing teams across QC, lab operations, instrument and equipment management, informatics, and data management. Preferred: Proven experience integrating instrument lifecycle, data and digital tools into workflows. Skills
Technical & Strategic Skills: Enterprise mindset aligning Quality needs to enterprise platforms; strong instrument program leadership from strategy to implementation; data analytics and data management; knowledge of data governance, systems integrations, and metadata management (a plus). Leadership & Soft Skills: Visionary leader; excels at collaboration with scientists, engineers, IT, and manufacturing; change agent for digital adoption; proven ability to build and manage high‑performing, multidisciplinary teams. Collaboration & Influence: Ability to partner with IT, QC, QA, regulatory, finance, and procurement; effective at stakeholder management and vendor relationships; represent Internal Quality in steering committees and working groups; align with drug development initiatives. Innovation & Change Leadership: Drive innovation, upskilling, communication planning, and user adoption; leverage AI and data‑driven workflows. Education
Relevant degrees: Bachelor's, Master's, or PhD in a field related to analytical science, engineering, or equivalent.
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Director, Analytical Instruments leads instrument control and data acquisition management for complex analytical instruments within Quality Control, supporting both small molecule and biologics. The role oversees implementation, qualification, ongoing operations, enhancements, decommissioning, and retirement of these instruments and their control software, ensuring regulatory compliance and data integrity. It drives automation of laboratory processes, champions emerging technologies including AI, and partners with Quality leadership, Technical Development, IT, Manufacturing, CMC Regulatory, Finance, and Procurement to enable data‑driven, digitally empowered workflows. The position is based in Foster City, CA. Responsibilities
Apply knowledge of analytical instrumentation and software across chromatography, microplate readers, mass spectrometry, endotoxin testing, titration, particle size analysis, Mettler‑Toledo instrument data acquisition, X‑ray diffraction, thermal analysis, nuclear magnetic resonance, optical rotation, infrared spectroscopy, and disintegration. Understand USP 1058, Analytical Instrument Qualification and its application. Responsible for instrument control and data acquisition software such as Waters Empower, Mettler‑Toledo LabX, Softmax Pro, MassHunter, OMNIC Paradigm, OPUS, TRIOS, and Tiamo. Maintain quality and compliance of instruments including data integrity, GMP adherence, and right‑first‑time execution. Lead business case development and ROI analysis for new complex instrument investments, effectively communicating trade‑offs between speed, cost, and scope to leadership and stakeholders. Critically analyze the instrument landscape, processes, metrics, pain points, and opportunities for improvement with GMP compliance, program delivery, vendor coordination, and inspection readiness. Deliver GMP analytical instruments and associated instrument control software to quality laboratories in a timely manner, with documentation, qualification, and processes meeting their intended use. Ensure instruments are highly available for testing by scientists and remain in a compliant state. Foster relationships with major instrument vendors such as Waters, ThermoFisher, Agilent, and Mettler Toledo. Continuously refine quality operations strategy and roadmaps aligned to organizational priorities and enterprise platforms. Maintain quality records for complex instrument deviations, change controls, CAPA actions, and ensure timely closure and resolution. Represent management and compliance of complex instruments during inspections. Communicate utilization, reliability, maintenance, and inventory information to leadership and stakeholders. Lead innovation and continuous improvement initiatives to optimize instrument management and lab workflows. Qualifications
Required: Bachelor's Degree and Twelve Years’ Experience; OR Masters’ Degree and Ten Years’ Experience; OR PhD and Eight Years’ Experience. Preferred: Hands‑on laboratory experience and analytical instrument use. Preferred: At least 5 years in a leadership role managing teams across QC, lab operations, instrument and equipment management, informatics, and data management. Preferred: Proven experience integrating instrument lifecycle, data and digital tools into workflows. Skills
Technical & Strategic Skills: Enterprise mindset aligning Quality needs to enterprise platforms; strong instrument program leadership from strategy to implementation; data analytics and data management; knowledge of data governance, systems integrations, and metadata management (a plus). Leadership & Soft Skills: Visionary leader; excels at collaboration with scientists, engineers, IT, and manufacturing; change agent for digital adoption; proven ability to build and manage high‑performing, multidisciplinary teams. Collaboration & Influence: Ability to partner with IT, QC, QA, regulatory, finance, and procurement; effective at stakeholder management and vendor relationships; represent Internal Quality in steering committees and working groups; align with drug development initiatives. Innovation & Change Leadership: Drive innovation, upskilling, communication planning, and user adoption; leverage AI and data‑driven workflows. Education
Relevant degrees: Bachelor's, Master's, or PhD in a field related to analytical science, engineering, or equivalent.
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