About this opportunity:

The Supplier Quality Specialist III/IV plays an integral role in supporting quality activities related to Supplier Management in accordance with FDA, ISO, and other IVD regulations. This individual also supports the company’s quality system activities that comply with the FDA’s Quality System Regulation 21 CFR § 820 and ISO 13485 as well as CLIA, CAP, and applicable state requirements. In this role you will facilitate the supplier compliance program (external audits, drive improvement in supplier performance, supplier development, supplier selection and qualification). In addition, this role will support the quality assurance activities in partner development as needed. 

What you’ll do:

• Maintain the approved supplier list and supplier audit schedule
• Drive compliance with applicable quality management system requirements, engaging in supplier corrective actions as needed
• Conduct external and internal quality audits to identify potential areas of risks and drive continuous improvement
  
• Lead establishing quality agreements with critical suppliers, and quality of supplier records
  
• Actively participate in supplier quality related communication and feedback.
  
• Lead the processing of supplier change notifications 
  
• Engage directly with Freenome suppliers to drive quality and process improvements in order to continuously improve the quality of product and services received
  
• Maintain supplier non-conformances to closure and effectiveness review, working with impacted departments
  
• Maintain organized records that demonstrate compliance to all company processes, regulations, and the company’s QMS
  
• Support routine Quality processes such as document control, employee training, investigating non-conformances, quality metrics, etc.

Must haves:

• Minimum of a Bachelor's degree in a life science field (genetics or molecular biology preferred) or equivalent experience
  
• 5+ years of experience in manufacturing operations, clinical laboratory operations, quality, or supplier quality
  
• ISO 13485 certified Lead Auditor or Certified Quality Auditor (CQA)
  
• Effective problem solving skills and ability to identify, analyze and solve problems with minimal direction and escalate concerns to management
  
• Proficiency in Word, Excel, PowerPoint or Google Workspace and experience with document management systems and document sharing systems
  
• Ability to prioritize and multitask while maintaining a positive and collaborative attitude
  
• Experience with both internal audits or external audits
  
• Effective verbal and written communication skills and ability to share and receive information from all levels of the organization throughout various departments
  
• Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
  
• Flexibility to successfully balance and prioritize multiple ongoing projects/tasks in a fast-paced, deadline driven environment
  
• Drive for results and continual improvement
  
• Travel 10 - 30% domestically and potentially internationally, potentially more as needed
  

Nice to haves:

• Certified Quality Engineer, CQE (ASQ)
• Experience in quality system methodologies including but not limited to CAPA, Lean, 5 Why's, Pareto Analysis, Six Sigma
• Experience with statistical process control (SPC) techniques to evaluate and improve process performance
• Experience with process validations
  

Additional information:

Contractors may be hired through a third-party provider and will be considered contingent workers. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal opportunity employer and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI-HYBRID

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Director, Drug Substance Manufacturing provides technical and operational leadership for drug substance manufacturing activities supporting Ultragenyx’s small molecule and oligonucleotide programs. This role is responsible for execution of departmental manufacturing strategies, management of external CMOs, and delivery of reliable clinical and commercial supply under cGMP conditions. The Director partners cross‑functionally to ensure safe, compliant, and efficient manufacturing while operating within established functional strategies. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Lead and manage drug substance manufacturing for synthetic molecules and oligonucleotides in a cGMP environment, supporting both clinical and commercial supply. 
2. Oversee production planning, execution, and performance tracking to ensure reliable fulfillment of agreed manufacturing services. 
3. Manage and strengthen CMO relationships, including selection, onboarding, governance, and ongoing performance management. 
4. Lead or contribute to CMC projects across the small molecule and oligonucleotide portfolio, ensuring alignment with development and supply strategies. 
5. Author and/or provide expert input into CMC sections for global regulatory filings, including INDs, IMPDs, NDAs, and MAAs. 
6. Serve as an integral member of cross‑functional and cross‑discipline CMC teams for programs containing synthetic components. 
7. Oversee process development, optimization, technology transfer, and lifecycle management, including change controls, deviations, and investigations. 
8. Ensure development and maintenance of manufacturing-related documentation, including Design History Files and Quality Risk Management Plans. 
9. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing and quality governance documents. 
10. Promote continuous improvement, knowledge management, and operational excellence while representing Drug Substance Manufacturing on global and cross‑functional teams. 

Requirements:

1. Ph.D. in chemistry, chemical engineering, organic chemistry, or a related discipline, or equivalent industry experience. 
2. 8–12 years of pharmaceutical or biopharmaceutical experience with progressive responsibility in CMC and manufacturing. 
3. Demonstrated experience in managing small molecule synthetic chemistry, pharmaceutical CMC development, process scale‑up, and cGMP manufacturing. 
4. Demonstrated experience managing and participating in cross‑functional CMC teams. 
5. Strong background in development and clinical manufacturing of small molecule drug substances; experience with oligonucleotides is a plus. 
6. Familiarity with QbD principles, DoE, process scale-up and optimization, validation/qualification, and phase‑appropriate controls. 
7. Solid knowledge of cGMP requirements, ICH guidelines, and phase‑appropriate controls.. 
8. Familiarity with analytical development and quality control is advantageous. 
9. Strong track record of building and sustaining effective CMO partnerships. 
10. Demonstrated ability to lead teams, manage complexity, and deliver results in a matrixed environment. 
11. Excellent written and verbal communication skills in English; additional languages are a plus. 
12. Demonstrated commitment to leadership development, coaching, and continuous learning. 

Physical Demand Requirements

Office‑based role with occasional presence in manufacturing and partner facilities. requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body may be required during site visits or when attending as person-in-plant. This requires the ability to change clothes into appropriate gowning and personal protective equipment.  

#LI-CT1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Director, Drug Product Manufacturing is an experienced operations leader responsible for CMC development and GMP manufacturing of Ultragenyx’s drug product formulations, including small molecule and oligonucleotide products. This role leads external drug product manufacturing activities, supports reliable clinical and commercial supply, and contributes to strategic planning within Technical Operations. The position serves as a recognized technical expert and partners cross‑functionally across Quality, Regulatory, Supply Chain, and Development organizations. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Lead external drug product manufacturing for small molecule and oligonucleotide products in a cGMP environment. 
2. Oversee production planning, execution, and performance tracking to ensure clinical and commercial supply commitments are met. 
3. Manage CMO relationships, including selection, onboarding, and performance management, fostering strong collaborative partnerships. 
4. Lead or support CMC activities across the drug product portfolio, including authoring and reviewing CMC sections for global regulatory filings (INDs, IMPDs, NDAs, MAAs). 
5. Serve as an integral member of cross‑functional CMC teams, partnering with Quality, Regulatory, Supply Chain, Development, and Clinical teams. 
6. Develop and maintain manufacturing documentation, including Product Design History Files and Quality Risk Management Plans. 
7. Oversee process development, technology transfer, process optimization, and lifecycle management activities. 
8. Manage manufacturing-related deviations, change controls, investigations, and complaint responses. 
9. Drive RFPs, Statements of Work, Master Service Agreements, and other manufacturing governance documents. 
10. Promote knowledge management, documentation best practices, continuous improvement, and operational excellence initiatives while representing Drug Product Manufacturing on global and cross‑functional teams. 

Requirements:

1. PhD or equivalent relevant experience in Pharmaceutical Sciences, Engineering, or related discipline. 
2. 10–15+ years of experience in pharmaceutical or biopharmaceutical manufacturing, preferably within global organizations. 
3. Demonstrated expertise in small molecule drug product development and clinical/commercial manufacturing; experience with multiple dosage forms preferred. 
4. Strong knowledge of QbD, DoE, process validation/qualification, phase‑appropriate manufacturing controls, PAT, and current regulatory expectations for drug products. 
5. Working knowledge of cGMP, ICH guidelines, and global regulatory submission requirements. 
6. Proven track record managing and sustaining effective CMO partnerships in a matrixed organization. 
7. Experience with analytical development and quality control is a plus. 
8. Strong problem‑solving, leadership, communication, and financial acumen. 
9. Commitment to coaching, feedback, and continuous learning and development.  

Physical Demand Requirements   

Office‑based role with occasional presence in manufacturing and partner facilities. requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body may be required during site visits or when attending as person-in-plant. This requires the ability to change clothes into appropriate gowning and personal protective equipment.  

#LI-CT1 #LI-Hybrid

Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Manager, CMC QA will be responsible for the Product Complaints, Annual Product Quality Review and CMC Change Control Review Board programs and will maintain strategic responsibility over QA Manufacturing Operations and will implement and communicate Ultragenyx’s CMC quality approach for the company. This role will direct and oversee operations in accordance with GxP regulations and Ultragenyx standards. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC 
2. Lead UGX Change Control Review Board program and provide coaching to Change Owners on the Change Control process as needed 
3. Support the release of production lots in accordance with Ultragenyx procedures 
4. Execution of Quality Systems in an Owner/SME or QA role, for Deviations, Change Controls and Product Quality Complaints 
5. Lead and actively participate in Continuous Improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by the CMC QA and cross-functional partners 
6. Design, develop, and review CMC QA standards and procedures (i.e., policy documents and SOPs). Review and support deployment of Quality Standards generated by the Quality System Department 
7. Support the Product Complaints function in investigating reported product quality events, as needed 
8. Represent Ultragenyx to Health Authorities during inspections 
9. Ensure activities and deliverables comply with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx policies, SOPs and industry best practices. 
10. Communicate and promote a culture of quality and operational excellence  
11. Other duties as assigned 

Requirements:

1. A Bachelor’s degree or equivalent work experience in QA Manufacturing Operations or related discipline.  
2. 8+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality. 
3. Experience with management of Change Control process and Review Board. 
4. Experience with Product Disposition.  
5. Demonstrate quality mindset and influences across the entire organization. 
6. Strong understanding unique quality and manufacturing expectations from other regulatory authorities such as EMA, ANVISA, MHRA, etc. 
7. Expert knowledge of GMPs. 
8. Flexibility and the ability to manage change. 
9. Strong interpersonal skills and the ability to work well as part of a team. 
10. Demonstrated ability for analytical and systematic thinking. 
11. Experience with Product Complaint handling, investigations, and reporting a plus. 
12. Fosters an environment of accountability, diversity and speaking up. 
13. Demonstrated high personal and professional ethical standards. 
14. Travel up to 10% of total work hours.  

#LI-CT1 #LI-Hybrid

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

Position

The Senior Manager / Associate Director, Computer Systems Assurance (CSA) is an important technical and operational leader within the Nurix Quality Systems organization, responsible for owning and advancing Nurix's computer systems assurance program. As a virtual drug developer, Nurix operates through a lean internal infrastructure and relies on a curated ecosystem of Software-as-a-Service (SaaS) and cloud-hosted platforms to support GxP-regulated activities across clinical development, quality operations, manufacturing oversight, and regulatory submissions. This role will serve as the primary subject matter expert and program owner for all CSA and computerized system validation (CSV) activities at Nurix.

Reporting to the Vice President / Senior Director, Quality Systems, this individual will establish and maintain Nurix's risk-based CSA framework aligned with current regulatory expectations, including the FDA's 2022 guidance on computer software assurance, GAMP 5 (2nd edition), and applicable 21 CFR Part 11 and Annex 11 requirements. The role requires an individual who combines deep technical knowledge of GxP computerized systems with practical experience in SaaS and cloud-based platform qualification, and who can translate regulatory requirements into pragmatic, fit-for-purpose validation approaches that support a modern, agile biotech environment. This is a high-impact, program-ownership role requiring both strategic vision and hands-on execution. The successful candidate will work closely with Quality, IT, Regulatory Affairs, CMC, Clinical Operations, and external vendors to ensure that all GxP-critical systems are appropriately assessed, validated, and maintained in a compliant state. The individual will champion a risk-based, science-driven approach to CSA across the organization.

Responsibilities

CSA Program Ownership and Strategy

• Own and maintain Nurix's Computer Systems Assurance policy framework, SOPs, and risk-based validation strategy, aligned with FDA CSA guidance (2022), GAMP 5 (2nd edition), 21 CFR Part 11, EU Annex 11, and applicable ICH guidelines.
• Define and implement a fit-for-purpose, risk-tiered approach to system qualification for SaaS and cloud-hosted GxP applications, recognizing the vendor-managed nature of modern software platforms.
• Maintain the GxP system inventory; conduct and document periodic system risk assessments to classify systems and determine appropriate validation scope and rigor.
• Establish and maintain processes for vendor assessment, including review of vendor SOC 2 reports, quality agreements, and audit strategies appropriate for SaaS providers.
• Drive continuous improvement of the CSA program through benchmarking, regulatory intelligence, and adoption of industry best practices.

System Validation and Qualification Execution

• Lead and execute validation activities for GxP SaaS platforms including, but not limited to, eQMS (e.g., Veeva Vault), electronic document management, clinical data management, regulatory information management, and laboratory information systems.
• Author and review validation documentation including Validation Master Plans (VMPs), User Requirements Specifications (URS), Risk Assessments, Vendor Assessments, Validation Protocols (IQ/OQ/PQ), Traceability Matrices, and Validation Summary Reports.
• Manage validation activities associated with system implementations, major configuration changes, upgrades, and periodic re-validation reviews, applying critical thinking to scope validation effort proportionate to system risk and change impact.
• Coordinate validation testing activities with cross-functional stakeholders; ensure test scripts are appropriately designed to demonstrate fitness for intended use.
• Review and approve validation deliverables prepared by internal teams, vendors, or external validation consultants.

21 CFR Part 11 and Data Integrity

• Serve as the internal subject matter expert for 21 CFR Part 11 and EU Annex 11 requirements; assess systems for compliance and provide guidance to cross-functional partners.
• Partner with IT and system owners to ensure electronic records and electronic signature controls are properly implemented and documented in all GxP systems.
• Support data integrity assessments and remediation initiatives; apply ALCOA+ principles to guide compliant system design and use.

Change Management and Periodic Review

• Manage the computerized systems change control process; evaluate proposed changes for validation impact and establish appropriate assessment, testing, and documentation requirements prior to implementation.
• Own and execute the periodic review program for validated GxP systems; assess continued fitness for intended use and compliance with current regulatory expectations.
• Maintain validation status documentation and ensure validation files are audit-ready at all times.

Inspection Readiness and Regulatory Support

• Support preparation for regulatory agency inspections; serve as the CSA subject matter expert during FDA, EMA, and other Health Authority inspections and ensure validation documentation is complete, current, and accessible.
• Contribute to relevant sections of regulatory submissions and respond to agency questions related to computerized systems and data integrity.
• Monitor evolving regulatory guidance and industry standards related to CSA, CSV, data integrity, and cloud-based systems; proactively adapt Nurix's program to reflect current expectations.

Cross-Functional Partnership and Training

• Serve as the primary point of contact and internal consultant for all GxP system owners across Quality, IT, Regulatory Affairs, CMC, and Clinical Operations.
• Develop and deliver CSA training for system owners, end users, and other stakeholders to build organizational capability and awareness.
• Partner with IT and vendor project teams to embed validation requirements early in system selection and implementation processes.

Required Qualifications

• Bachelor's degree in computer science, information systems, life sciences, pharmaceutical sciences, or a related field.
• 7–10+ years of progressive experience in computer systems validation and/or computer systems assurance in a GxP-regulated pharmaceutical, biopharmaceutical, or biotechnology environment.
• Demonstrated expertise in current regulatory requirements for computerized systems, including FDA 21 CFR Part 11, EU Annex 11, FDA CSA guidance (2022), and GAMP 5 (2nd edition).
• Hands-on experience validating SaaS and cloud-hosted GxP platforms; understanding of vendor-managed environments and shared responsibility models.
• Proficiency authoring and reviewing CSA/CSV deliverables: VMPs, URSs, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Strong working knowledge of data integrity principles (ALCOA+) and their application to electronic records management and GxP system design.
• Experience managing system change control and periodic review programs for validated GxP systems.
• Ability to operate as both program owner and individual contributor in a lean, virtual organizational model; comfortable managing validation activities without a large internal support team.
• Excellent written and verbal communication skills; able to translate complex technical and regulatory requirements into practical guidance for diverse stakeholders.
• Strong organizational skills and attention to detail; demonstrated ability to manage multiple concurrent programs and priorities in a fast-paced environment.

Preferred Qualifications

• Experience with eQMS validation (e.g., Veeva Vault) and familiarity with Veeva's Qualified System approach and available supplier documentation.
• Familiarity with clinical development platforms such as electronic data capture (EDC), regulatory information management (RIM), or clinical trial management systems (CTMS) in a validated context.
• Experience supporting FDA, EMA, or equivalent Health Authority inspections as a CSA subject matter expert.
• Exposure to laboratory informatics systems (LIMS, ELN) and their GxP qualification requirements.
• Experience in a virtual or lean biotech environment managing validation activities through external vendors and consultants.
• Working knowledge of cybersecurity frameworks and their intersection with GxP system compliance (e.g., NIST, SOC 2).
• Advanced degree in a relevant scientific, engineering, or regulatory discipline.

Fit with Nurix Culture and Values

• You know the regulations deeply and apply them with judgment, designing validation approaches that are rigorous where it matters and efficient everywhere else. You bring expertise with pragmatism —
• You are comfortable as the go-to expert, driving the CSA program forward proactively rather than waiting for direction, and you take accountability for outcomes. You own the program —
• You build trusted relationships across Quality, IT, and the business, and you understand that a well-designed, compliant systems environment is an enabler of Nurix's mission to develop important medicines for patients. You partner with purpose —

Location: Brisbane, CA - Onsite 

Salary Ranges: Senior Manager, CSA(Quality)      - $170,538 – $193,493                                  
                           Associate Director, CSA(Quality) - $190,269 – $216,360

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix.  By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/). 

Position Summary:

The Associate Director, GxP Systems will report to the Sr. Director, Commercialization Systems and will be responsible for leading the implementation, validation, and support of GxP-regulated systems to enable Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a commercial biotech environment. This role will play a pivotal part in supporting regulatory, compliance, and for commercialization. Working with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M functions to ensure systems are fit-for-purpose, validated and aligned with evolving business requirements.

Responsibilities:

• Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
• Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
• Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
• Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
• Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
• Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
• Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
• Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
• Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
• Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
• Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
• Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

Qualifications:

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred
• 10-12 years of hands-on experience with GxP systems in Life Sciences, including system administration, validation oversight, and operational support
• Proven experience implementing and validating systems such as eQMS, TraceLink, LMS, Validated Documents and Data storage solutions (such as Box for GxP or Egnyte Life Sciences), or ERP systems (e.g., NetSuite, Oracle, SAP) in a GxP-regulated environment
• Strong understanding of CSV, data integrity, Part 11 compliance, and regulatory expectations (FDA, EMA, ICH)
• Experience partnering with validation/CSV resources while maintaining accountability for system compliance and validation outcomes
• Proven experience owning and managing Change Control processes for GxP systems
• Experience supporting pre-commercial biotech organizations transitioning to commercialization
• Ability to balance strategic oversight with hands-on system administration and operational responsibilities
• Strong cross-functional collaboration skills across IT, QA, Regulatory, and Technical Operations
• Experience managing vendors and implementation partners
• Excellent troubleshooting, analytical, and problem-solving skills
• Strong communication skills with the ability to translate technical concepts into business terms and influence stakeholders

Position Summary 

The Practice Manager | Accounting is responsible for the effective leadership, coordination, and continuous improvement of practice management for the accounting division across all locations. The role provides strategic and operational oversight of onshore and offshore teams and ensures consistent, efficient, and high‑quality service delivery aligned with the organisation’s objectives and regulatory requirements.

Working closely with the Head of Accounting, this position plays a key role in driving operational excellence, supporting sustainable growth, and fostering strong working relationships across offices, service lines, and global teams.

This role can be located in Brisbane, Queensland, Australia; Melbourne, Victoria, Australia; Sydney, New South Wales, Australia.

Primary Responsibilities

Strategic Accounting Operations Management:

• Lead and optimise operations across all locations, ensuring alignment with broader company goals and strategic initiatives.
• Develop and execute scalable processes and systems to drive operational efficiency and productivity across the division.
• Work with the Head of Accounting and the Compliance Team to ensure all regulatory and organisational standards are met, ensuring a high level of quality control across the division.

Global Team Leadership & Management:

• Lead and manage both onshore Client Services Team and offshore teams, fostering a culture of collaboration and excellence in line with company values.
• Design and implement best practices for managing offshore teams
• Drive the performance of global teams, ensuring high-quality outcomes, productivity, and alignment with business objectives.
• Drive change management initiatives to support global team integration and performance.

Relationship Management:

• Cultivate and maintain strong, long-term working relationships across multiple locations, serving as the trusted point of contact.
• Understand client needs and work proactively to exceed expectations by delivering high-quality services.
• Identify improvements in service delivery, and ways to drive client satisfaction and retention.

Financial Leadership & Budgeting:

• Work closely with senior leadership and finance teams to monitor and optimise office expenses and resource allocation.
• Ensure accurate billing, timely invoicing, and financial reporting in alignment with the company’s standards and client agreements.
• Identify opportunities for cost optimisation and revenue growth.

Operational Excellence & Continuous Improvement:

• Lead the development of a culture of continuous improvement, proactively identifying and implementing strategies to enhance division and team performance.
• Utilise data and insights to measure key performance indicators (KPIs) and drive operational decisions.
• Collaborate with the Leadership Team to define and implement long-term growth strategies, including resource planning and technology integration.

Risk Management & Problem Solving:

• Identify and mitigate risks related to the division’s operations, employee performance, client relations and global team dynamics.
• Maintain divisions risk matrix.
• Liaise with the Head of Accounting to provide solutions to complex operational issues, working across teams to implement corrective actions and improve processes.
• Act as a key decision-maker for resolving conflicts, operational bottlenecks, and client service concerns, working closely with the Head of Accounting.

Qualifications 

• Extensive experience (7+ years) in managing multi-office operations, ideally within a practice-based environment.
• Proven success in managing offshore teams, with a deep understanding of the challenges and nuances of offshore operations.
• Demonstrated leadership skills, including team management, development, and performance optimisation.
• Exceptional communication and interpersonal, skills, with the ability to engage and influence stakeholders at all levels.
• Strong financial acumen with the ability to manage budgets, expenses and cost optimisation.
• Advanced problem-solving abilities and strategic thinking, with a focus on long-term growth and efficiency.
• Proven ability to drive operational excellence and continuous improvement in dynamic environments.
• Strong understanding of accounting/financial principles and operational best practices.

About Focus Partners Australia 

Focus Partners Australia is part of Focus Financial Partners, a leading financial services firm based in the United States, comprised of wealth management, family office, and business management services. Focus Partners Australia offers integrated capabilities in investment and portfolio management, accounting, lending, insurance and related services from its offices in Sydney, Melbourne, Brisbane and the Gold Coast. Guided by a client-first ethos, we leverage the global expertise, platforms and capital strength of Focus Financial Partners to deliver holistic, fiduciary guidance across strategic planning, portfolio management, insurance, credit and tax. By fusing local insight with world-class resources, Focus Partners Australia helps its clients protect, grow, and transition their wealth at every life stage. Discover more about Focus Partners Australia at focuspa.com.au/ or LinkedIn.  

As a Specialist OT Engineer, you’ll be joining the IT & Security team responsible for maintaining High System Integrity Protection Scheme (SIPS) Performance at Waratah Super Battery; the most powerful BESS globally. In addition, the team recently achieved commercial operation date (COD) alongside the first full month of operational reporting for Akaysha’s Ulinda Park BESS.  

Building on this momentum, the role will focus on establishing and sustaining stable, reliable day-to-day OT system operations across multiple live sites. You will play a key role in supporting BAU activities, maintaining system integrity, and ensuring OT environments operate safely and predictably over time. 

Each site presents unique technical and operational considerations, offering the opportunity to deepen your experience in supporting the reliability, performance, and security of operational technology systems. This includes hands on involvement with SCADA servers and HMIs, as well as PCS, BMS, and EMS subsystems, throughout the operations and maintenance phase of largescale energy assets.  

Your expertise will be critical in enabling stable, visible and secure OT environments across Akaysha’s portfolio of assets with your work making a tangible impact as you: 

• Manage and maintain OT infrastructure—including SCADA, HMIs, BESS, gateways, and historians—while overseeing configuration, documentation, system health, automation, and lifecycle planning. 
  
  
• Support secure, governed OT–cloud integration (Azure/AWS) with accurate, high‑quality data flows for real‑time analytics and AI‑driven maintenance 
  
  
• Apply OT cybersecurity and compliance practices across AESCSF/IEC‑62443, hardening, secure access, monitoring, vulnerability management, asset control, backups, and SOCI requirements. 
  
  
• Maintain and troubleshoot OT system performance and communications across SCADA, RTUs, historians, and BESS subsystems while resolving incidents, supporting on‑call operations, and improving OT architectures and practices. 
  
  
• Coordinate OT vendor support, technical reviews, compliance, lifecycle planning, Tier 2/3 assistance, and commissioning activities while reviewing documentation and deliverables. 

Travel to AU sites once every 2-3 months or when needed, is a requirement of this position. The role can be based at Akaysha’s Melbourne (HQ), Sydney or Brisbane office with the option to work in a hybrid capacity – spending time in the office, and at home. 

Making an impact in this role will rely on proven expertise in the following areas:   

• Industrial Control Systems (ICS) & SCADA 
  Expertise in configuring and optimising ICS environments, including SCADA, HMIs, PLCs, RTUs, and IEDs for real‑time operations.
  
  
• Industrial Communication Protocols 
  Skilled in applying and interpreting industrial protocols - Modbus, DNP3, IEC 61850, and OPC/OPC‑UA—to ensure reliable device and system communication. 
  
  
• OT Cybersecurity 
  Proficient in applying OT security frameworks (AESCSF, IEC 62443) to guide hardening, segmentation, and secure system architecture. 
  
  
• Troubleshooting & Systems Diagnostics 
  Skilled in diagnosing faults across OT networks, control systems, data pipelines, and BESS subsystems using structured problem‑solving and root‑cause methods. 
  
  
• Cloud‑Integrated OT Systems 
  Knowledge of OT–cloud integration patterns, including telemetry pipelines, secure connectivity, and cloud‑based monitoring and analytics. 
  
  
• Vendor & Contractor Coordination 
  Experienced in coordinating technical validation and lifecycle activities with OEMs, service providers, and contractors across reviews and assessments. 
  
  
• Technical Documentation 
  Proficient in producing clear, accurate technical documentation, including diagrams, procedures, system records, and operational artefacts. 

Senior Manager, Quality Operations

Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation therapeutics. Leveraging our proprietary DELigase platform, we design small molecules that harness the body’s own protein disposal system to selectively eliminate disease-causing proteins. Our pipeline spans oncology and immune-mediated diseases, and our team is united by a commitment to scientific excellence and meaningful impact for patients.

We are a team of scientists, innovators, and problem-solvers committed to improving patient lives. We value integrity in everything we do — from the bench to the boardroom — and we foster an environment where every voice is heard and every contribution matters.

Position

The Senior Manager, Quality Operations is an important operational and technical contributor within the Nurix Quality organization, responsible for supporting the quality operations and GMP compliance activities that underpin Nurix’s clinical development programs. This role will partner closely with CMC teams, CDMOs, and internal stakeholders to ensure quality oversight across drug manufacturing, laboratory operations, auditing, and inspection readiness.  Reporting to the Senior Director, Quality, the Senior Manager will execute essential quality systems activities including deviation management, change control, CAPA, batch record review, and audit support. This individual will demonstrate strong independent judgment, meticulous attention to detail, and the ability to collaborate effectively across functions in a dynamic, early to late clinical-stage environment where quality and program timelines are closely intertwined

Responsibilities

Drug Manufacturing Quality Operations

• Execute and support quality systems operations for clinical development, including document management, deviation management, change control, CAPA, training, and validation activities.
• Provide day-to-day quality oversight of CDMOs and contract laboratory operations, including review and approval of deviations, OOS/OOT investigations, batch records, specifications, sampling and testing plans, analytical methods, and lot disposition decisions.
• Review and approve development, process transfer, and validation protocols and reports; verify process data in support of CMC regulatory submissions (INDs and NDAs).
• Approve production-related activities including master batch records, change controls, stability study protocols and reports, and certificate of analysis reviews.
• Participate in CMO selection, commissioning, qualification, and certification activities, support negotiation and maintenance of quality agreements with contract manufacturing partners.
• Support risk management assessments of suppliers and manufacturing processes.
• Manage and file quality documents in the electronic document management system; ensure timely completion of document lifecycle activities in compliance with internal procedures.

Quality Auditing

• Support domestic and international GMP audits of contract manufacturers and laboratory service providers; collaborate cross-functionally with internal stakeholders to assess compliance with applicable regulations and Nurix SOPs.
• Support internal quality audits to evaluate Nurix’s GMP compliance; document findings, prepare audit reports, and track corrective action commitments.
• Communicate audit findings clearly to auditees and management; partner with auditees to develop thorough root cause analyses and CAPA plans. 

Inspection Readiness

• Support preparation and coordination for regulatory agency inspections of Nurix and contract manufacturing partners, including pre-approval inspections (PAIs).
• Assist with inspection logistics, document preparation, back-room operations, and response coordination during Health Authority GMP inspections.
• Contribute to ongoing inspection readiness programs, including gap assessments, mock inspection activities, and training.

Qualifications

• Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, or a related field.
• 7+ years of progressive Quality Assurance experience in clinical or commercial pharmaceutical or biopharmaceutical operations, with demonstrated hands-on responsibility for GMP quality systems
• Strong working knowledge of GMP regulations and their practical application in CMC development and CDMO management (21 CFR Parts 210/211, ICH Q7, Q8, Q9, Q10, EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines).
• Hands-on experience with deviation investigations, CAPA management, change control processes, and batch record review and approval.
• Ability to travel to CDMO and laboratory sites domestically and internationally, as needed.
• Experience supporting or conducting GMP audits of contract manufacturers and laboratory service providers; ability to write clear, comprehensive audit reports.
• Familiarity with regulatory submission processes and experience reviewing or contributing to CMC sections of regulatory filings.
• Proficiency with eQMS platforms, electronic document management systems, and Microsoft Office suite.
• Strong attention to detail and organizational skills; demonstrated ability to manage multiple concurrent priorities and deliver against deadlines.
• Excellent written and verbal communication skills; able to work effectively across functions and with external manufacturing partners.
• Ability to travel to CDMO and laboratory sites domestically and internationally, as needed.

Salary Range:  $137,859 - $155,758 plus bonus & equity.

Location:  Brisbane, CA – Onsite

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix.  By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/). 

Senior Director, Quality Assurance 

Nurix Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation therapeutics. Leveraging our proprietary DELigase platform, we design small molecules that harness the body's own protein disposal system to selectively eliminate disease-causing proteins. Our pipeline spans oncology and immune-mediated diseases, and our team is united by a commitment to scientific excellence and meaningful impact for patients.We are a team of scientists, innovators, and problem-solvers committed to improving patient lives. We value integrity in everything we do — from the bench to the boardroom — and we foster an environment where every voice is heard and every contribution matters.

Position

The Senior Director, Quality Assurance is a leadership role within the Nurix Quality organization, responsible for providing strategic and operational oversight of GMP/GLP quality assurance activities supporting small molecule CMC development. This leader will serve as the primary quality interface with external contract development and manufacturing organizations (CDMOs), ensuring the quality, compliance, and timely supply of clinical materials across Nurix’s pipeline programs.

Reporting to the Senior Vice President, Quality, the Senior Director will apply sound independent judgment to drive timely identification, investigation, and resolution of quality events, while building a culture of continuous improvement and cross-functional collaboration. This individual will be accountable for regulatory inspection readiness, quality oversight of external manufacturing and laboratory partners, and for contributing to the evolution of Nurix’s quality systems as the company advances through late-stage clinical development and toward commercialization.

This is a high-visibility role with direct accountability across Quality, CMC, Regulatory Affairs, and external manufacturing partners. The Senior Director will lead and mentor a team of Quality Assurance professionals and will be expected to operate both strategically and hands-on as needed in a dynamic, early to late clinical-stage environment.

Responsibilities

• Provide strategic quality leadership for CMC development programs, ensuring GMP/GLP compliance with FDA, Ex-US regulatory authorities, and ICH guidelines across drug substance and drug product development.
• Oversee quality operations at CDMOs and contract laboratories, including review and approval of deviations, investigations, batch records, lot disposition, technical protocols and reports, methods, and specifications.
• Lead and develop a team of Quality Assurance professionals; establish clear performance expectations, provide mentorship, and build organizational capability to support pipeline advancement and commercialization readiness.
• Drive timely identification, investigation, and resolution of quality events and deviations; oversee CAPA execution and effectiveness verification to prevent recurrence.
• Manage the change control process, ensuring appropriate capture of changes impacting internal procedures and regulatory filings; communicate and escalate issues with broad cross-functional impact.
• Lead regulatory inspection readiness activities; serve as a senior quality representative during FDA, EMA, and other agency inspections and manage observation responses.
• Contribute to CMC sections of regulatory filings (INDs, NDAs/BLAs) and support responses to agency questions in partnership with Regulatory Affairs.
• Partner with CMC and Regulatory Affairs teams to align quality deliverables with pipeline milestones and program timelines.
• Champion continuous improvement of quality assurance processes and procedures, leveraging data, metrics, AI tools, and cross-industry best practices.
• Support implementation and optimization of electronic quality management systems (eQMS) platform; contribute to system improvement initiatives.
• Maintain current knowledge of evolving regulatory expectations and industry standards; translate requirements into practical operational guidance for the organization.

Qualifications 

• Bachelor’s degree in chemistry, pharmaceutical sciences, life sciences, or a related field.
• 12+ years of progressive Quality Assurance experience in the pharmaceutical or biopharmaceutical industry, with experience in formal leadership role.
• Deep technical expertise in GMP requirements for small molecule drug substances and drug products across clinical development stages.
• Demonstrated experience managing CDMO relationships and overseeing quality operations at contract manufacturing and laboratory organizations.
• Thorough knowledge of FDA regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q8, Q9, Q10, Q11), and EudraLex - Volume 4 - Good Manufacturing Practice (GMP) and their practical application to CMC development.
• Proven track record managing quality events, deviations, CAPA programs, and change control in a clinical or commercial pharmaceutical setting.
• Experience supporting or leading regulatory agency inspections (FDA, EMA, or equivalent); experience as lead QA representative during pre-approval inspections preferred.
• Demonstrated ability to lead, develop, and motivate Quality Assurance teams in a fast-paced, ambiguous, clinical-stage environment.
• Excellent project management skills with the ability to manage multiple high-priority deliverables simultaneously.
• Strong verbal and written communication skills; able to present complex quality and compliance topics clearly to diverse stakeholders, including executive leadership.
• Willingness to travel to CDMO and laboratory sites domestically and internationally, as needed.

Preferred Qualifications 

• Experience in a clinical-stage biotech environment scaling quality operations through late-stage development and toward commercialization.
• Experience with electronic QMS platforms (e.g., Veeva Vault) and document management systems.
• Expertise in both development-phase and pre-commercial-phase quality assurance standards and expectations.

Fit with Nurix Culture and Values 

• You lead with integrity and set the standard — you bring the same rigor and accountability to quality systems that our scientists bring to the bench
• You are a builder who thrives in ambiguity, energized by the opportunity to shape something meaningful from the ground up in a high-growth environment
• You invest in people — you know that sustainable quality outcomes depend on capable, engaged teams, and you take developing others as seriously as you take system compliance

Salary Range: $238,155 - $270,990 plus bonus and equity 

Location:  Brisbane, CA – Onsite

Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix.  By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/). 

Applicants must be legally authorized to work for any employer in the United States.

Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.

PsiQuantum’s mission is to build the first useful quantum computers—machines capable of delivering the breakthroughs the field has long promised. Since our founding in 2016, our singular focus has been to build and deploy million-qubit, fault-tolerant quantum systems. 

Quantum computers harness the laws of quantum mechanics to solve problems that even the most advanced supercomputers or AI systems will never reach. Their impact will span energy, pharmaceuticals, finance, agriculture, transportation, materials, and other foundational industries. 

Our architecture and approach is based on silicon photonics. By leveraging the advanced semiconductor manufacturing industry—including partners like GlobalFoundries—we use the same high-volume processes that already produce billions of chips for telecom and consumer electronics. Photonics offers natural advantages for scale: photons don’t feel heat, are immune to electromagnetic interference, and integrate with existing cryogenic cooling and standard fiber-optic infrastructure. 

In 2024, PsiQuantum announced government-funded projects to support the build-out of our first utility-scale quantum computers in Brisbane, Australia, and Chicago, Illinois. These initiatives reflect a growing recognition that quantum computing will be strategically and economically defining—and that now is the time to scale. 

PsiQuantum also develops the algorithms and software needed to make these systems commercially valuable. Our application, software, and industry teams work directly with leading Fortune 500 companies—including Lockheed Martin, Mercedes-Benz, Boehringer Ingelheim, and Mitsubishi Chemical—to prepare quantum solutions for real-world impact. 

Quantum computing is not an extension of classical computing. It represents a fundamental shift—and a path to mastering challenges that cannot be solved any other way. The potential is enormous, and we have a clear path to make it real. 

Come join us. 

Job Summary:

PsiQuantum is rapidly scaling to build the world's first useful fault-tolerant quantum computer. At the forefront of this effort, we need a motivated physicist/engineer to join our new laboratory in Brisbane and help us test the limits of our beyond-state-of-the-art quantum photonic platform. This role will focus on the validation and high-performance operation of our quantum photonic systems, and the development and validation of related methodology. The successful candidate will be responsible for executing experiments—including data analysis and interpretation—to validate and calibrate quantum computer subsystems to fault-tolerant levels at high cadence. They will also assist with experimental design. They will identify physical processes that limit photonic quantum performance and feedback new understandings to improve designs and operations of future generation of quantum hardware, and new generations of validation methodologies. They will collaborate broadly with design and engineering teams across all of PsiQuantum’s technical disciplines, including optics, quantum optics, photonics, electronics, cryogenics, quantum architecture, and software to understand system performance and inform engineering models.

Responsibilities:

• Be part of a team pushing photonic quantum computing hardware to fault-tolerant quantum performance.
• Development of classical and non-classical measurements and procedures, and execution of these, to validate optical quantum computer systems performance.
• Develop and verify methods for calibration, self-test, and control of novel quantum photonic systems.
• Develop clear and quantitative metrics for quantum performance.
• Work with other teams to ensure that developed, defined, and documented validation objectives fit with the broader company mission and timeframes.
• Develop requirements for the software and electronics teams to implement procedures and manage data.
• Analyse, reduce, and deliver experimental data. Work with other engineering teams to ensure that the data informs engineering models for system performance.
• Debug complex systems and work with other engineering teams to conduct failure analysis and resolve design or manufacturing issues as appropriate.
• Communicate validation outcomes broadly to internal stakeholders and help guide corrective actions.
• Work on-site in the lab in Brisbane, Australia.

Experience/Qualifications:

• Ph.D or equivalent experience in experimental quantum optics/quantum physics, photonic/electrical engineering, or a related field, and a demonstrated track record of delivering high quality research outcomes.
• Demonstrated expertise in the design and execution of complex quantum experiments in a cross-functional environment.
• Broad technical knowledge with ability to dive deep into required technical areas of our systems including hardware, software, controls, precision measurement, photonics, and quantum information.
• Software development for instrumentation, controls, test equipment, and data analysis (python preferred).
• Proven team player with an ability to work effectively across departments, sites, time zones.
• Excellent verbal and written communication skills with an ability to communicate effectively to a variety of audiences including senior leadership and technical experts.
• Demonstrated interest in PsiQuantum’s mission and vision for quantum computing, with an ability to contribute within a fast-paced start-up environment consistent with PsiQuantum’s values of communication, collaboration, respect, results, and challenge.

PsiQuantum provides equal employment opportunity for all applicants and employees. PsiQuantum does not unlawfully discriminate on the basis of race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), gender identity, gender expression, national origin, ancestry, citizenship, age, physical or mental disability, military or veteran status, marital status, domestic partner status, sexual orientation, genetic information, or any other basis protected by applicable laws.

Note: PsiQuantum will only reach out to you using an official PsiQuantum email address and will never ask you for bank account information as part of the interview process. Please report any suspicious activity to recruiting@psiquantum.com.

We are not accepting unsolicited resumes from employment agencies.

About this opportunity:

At Freenome, we are seeking a Senior Machine Learning Research Engineer to join the Machine Learning Science (MLS) team, within the Computational Science department. The ideal candidate has a strong knowledge in designing and building deep learning (DL) pipelines, and expertise in creating reliable, scalable artificial intelligence/machine learning (AI/ML) systems in a cloud environment. 

The MLS team at Freenome develops DL models using massive-scale genomic data that presents significant challenges for current training paradigms. The Senior Machine Learning Research Engineer will primarily be responsible for developing and deploying the infrastructure needed to support development of such DL models: enabling distributed DL pipelines, optimizing hardware utilization for efficient training, and performing model optimizations. As part of an interdisciplinary R&D team, they will work in close collaboration with machine learning scientists, computational biologists and software engineers to accelerate the development of state-of-the-art ML/AI models and help Freenome achieve its mission of reducing cancer mortality via accessible early detection.

The role reports to the Director of Machine Learning Science. This can be a hybrid role based in our Brisbane, California headquarters (2-3 days per week in office), or remote.

What you’ll do:

• Implement and refine DL pipelines on distributed computing platforms enhancing the speed and efficiency of DL operations including model training, data handling, model management, and inference.
• Collaborate closely with ML scientists and software engineers to understand current challenges and requirements and ensure that the DL model development pipelines you create are perfectly aligned with scientific goals and operational needs.
• Continuously monitor, evaluate, and optimize DL model training pipelines for performance and scalability.
• Stay up to date with the latest advancements in AI, ML, and related technologies, and quickly learn and adapt new tools and frameworks, if necessary.
• Develop and maintain robust and reproducible DL pipelines that guarantee that DL pipelines can be reliably executed, maintaining consistency and accuracy of results.
• Drive performance improvements across our stack through profiling, optimization, and benchmarking. Implement efficient caching solutions and debug distributed systems to accelerate both training and evaluation pipelines.
• Act as a bridge facilitating communication between the engineering and scientific teams, documenting and sharing best practices to foster a culture of learning and continuous improvement.

Must haves:

• MS or equivalent experience in a relevant, quantitative field such as Computer Science, Statistics, Mathematics, Software Engineering, with an emphasis on AI/ML theory and/or practical development.
• 5+ years of post-MS industry experience working on developing AI/ML software engineering pipelines.
• Proficiency in a general-purpose programming language: Python (preferred), Java, Julia, C, C++, etc.
• Strong knowledge of ML and DL fundamentals and hands-on experience with machine learning frameworks such as PyTorch, TensorFlow, Jax or Scikit-learn.
• In-depth knowledge of scalable and distributed computing platforms that support complex model training (such as Ray or DeepSpeed) and their integration with ML developer tools like TensorBoard, Wandb, or MLflow.
• Experience with cloud platforms (e.g., AWS, Google Cloud, Azure) and how to deploy and manage AI/ML models and pipelines in a cloud environment.
• Understanding of containerization technologies (e.g., Docker) and computing resource orchestration tools (e.g., Kubernetes) for deploying scalable ML/AI solutions.
• Proven track record of developing and optimizing workflows for training DL models, large language models (LLMs), or similar for problems with high data complexity and volume.
• Experience managing large datasets, including data storage (such as HDFS or Parquet on S3), retrieval, and efficient data processing techniques (via libraries and executors such as PyArrow and Spark).
• Proficiency in version control systems (e.g., Git) and continuous integration/continuous deployment (CI/CD) practices to maintain code quality and automate development workflows.
• Expertise in building and launching large-scale ML frameworks in a scientific environment that supports the needs of a research team.
• Excellent ability to work effectively with cross-functional teams and communicate across disciplines. 
  

Nice to haves:

• Experience working with large-scale genomics or biological datasets.
• Experience managing multimodal datasets, such as combinations of sequence, text, image, and other data.
• Experience GPU/Accelerator programming and kernel development (such as CUDA, Triton or XLA).
• Experience with infrastructure-as-code and configuration management.
• Experience cultivating MLOps and ML infrastructure best practices, especially around reliability, provisioning and monitoring.
• Strong track record of contributions to relevant DL projects, e.g. on github.
  

Benefits and additional information:

The US target range of our base salary for new hires is $161,925 - $227,325 You will also be eligible to receive equity, cash bonuses, and a full range of medical, financial, and other benefits depending on the position offered.  Please note that individual total compensation for this position will be determined at the Company’s sole discretion and may vary based on several factors, including but not limited to, location, skill level, years and depth of relevant experience, and education. We invite you to check out our career page @ freenome.com/job-openings/ for additional company information.  

Freenome is proud to be an equal-opportunity employer, and we value diversity. Freenome does not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Applicants have rights under Federal Employment Laws.  

• Family & Medical Leave Act (FMLA)
• Equal Employment Opportunity (EEO)
• Employee Polygraph Protection Act (EPPA)

#LI-REMOTE

Role

As a Principal Mechanical Engineer at Vivodyne, you will be part of a multi-disciplinary team pushing the boundaries of automated, large-scale "organ-on-a-chip" robotics and related manufacturing systems. Your focus will be on developing and optimizing hardware and software that orchestrates robotic arms, embedded controllers, and microfluidic systems to enable high-throughput, high-precision biological workflows.

This role requires expertise across hardware and software, but primarily hardware.  From high-level motion control and machine vision to robotics programming and embedded firmware. You’ll work extensively with existing Python (less so with, C#, and C++) codebases, ensuring seamless system integration and performance.

You are a mechanical design expert.  Things like kinematic docking, 440 vs 316, FEA, and error budgets are very familiar to you.  Your friends include McMaster-Carr, Misumi, and Grainger. 

Collaboration is key—you’ll engage with mechanical engineers, biologists, immunologists, AI scientists, and process engineers to design and refine automation workflows that drive breakthroughs. We’re looking for a problem solver comfortable working across multiple domains, thriving in a fast-paced, high-innovation environment that values continuous learning and technical excellence.

This is a full-time, onsite role in San Francisco, where you’ll be designing, building, and testing some of the most advanced automation and high-throughput biology systems in the world.

Responsibilities

• Architect, design, and implement advanced automation systems, ranging from automated microfluidic manufacturing to high-precision mammalian cell culture platforms—all of which are mission-critical and highly visible both internally and externally.
• Develop hardware and software systems that acquire and process data reliably, ensuring smooth handoffs to production through rigorous documentation, data acquisition, and analysis.
• Embrace the dynamic nature of a rapidly growing startup, working across multiple projects and disciplines.
• Collaborate cross-functionally with Product leads, tissue engineers, microfluidics specialists, and AI researchers etc. to gather requirements, set technical objectives, and integrate new features into our robotics platforms.
• Design and implement resilience mechanisms to ensure system robustness, enabling fault detection, fault recovery, and minimal downtime, while maintaining data integrity.
• Proactively identify optimization opportunities, selecting priorities through engineering analysis and data-driven decision-making.
• Communicate progress and findings to internal stakeholders—including mechanical engineers, data scientists, and senior leadership—through data-laden presentations and technical reports.

Requirements and Expectations

Technical Expertise & Knowledge

• Bachelor’s degree (M.S. or Ph.D. preferred) in Mechanical Engineering, Chemical Engineering, or a related field with a focus on microfluidics, tissue engineering, or lab automation at least six years of directly relevant industry experience.
• Broad experience in hardware and, preferable, software design for automation, spanning off-the-shelf solutions and custom-built systems—you have developed complex automation workflows for production-level environments.
• Proficiency in key hardware and software tools, including SolidWorks (expert-level, CAM experience is a plus), and at some exposure to Python/Matlab/C++/C#/Javascript/etc.
• Hands-on experience with commonly used automation hardware, such as vision/camera systems (optics and/or optomechanical expertise is a plus), motion control, liquid handling, and pick-and-place robotics.
• Highly knowledgeable in various Manufacturing Technologies, you know how things are made and which approaches fit a particular application
• Industry-specific expertise is highly valued:
• Biotech/lab automation or semiconductor robotics experience is a strong advantage.
• Knowledge of microfluidics and fluid handling systems.
• Experience integrating robotics with high-content imaging and confocal microscopy systems, optimizing workflows for advanced imaging pipelines.
• Biology background or familiarity with cell and tissue engineering concepts is a significant plus, especially in handling biological samples.
• Bonus points for experience with:
• Electronics/PCBA design or basic knowledge (reading schematic, troubleshooting interconnects), statistical analysis/data collection to inform design performance rigorously

Problem Solving & Ownership

• You take an outcome-driven approach, translating project goals and technical challenges into systematic, resilient robotics solutions.
• Strong ownership mentality, ensuring the timely delivery of high-reliability features and improvements.
• Growth-oriented, continuously seeking ways to enhance automation processes, optimize robotic operations, and drive innovation.

Collaboration & Communication

• A team player, capable of working with engineers, scientists, and external stakeholders to define requirements, refine designs, and communicate project progress effectively.
• Clear communicator, able to explain complex robotics concepts to cross-functional teams, from software engineers to biologists.
• Interdisciplinary mindset, integrating feedback from various fields to develop thoughtful, iterative design improvements.

Innovation & Leadership Mindset

• Passionate about staying at the cutting edge of robotics, bringing fresh ideas from emerging technologies, best practices, and research to the team.
• Comfortable taking initiative in uncharted territories, whether it’s developing new motion-planning algorithms or integrating novel sensors and hardware.

Why Vivodyne?

• High-Impact Mission – Play a pivotal role in transforming drug discovery and human therapeutics through advanced robotics and automation.
• Multi-Disciplinary Exposure – Work alongside leading experts in robotics, AI, biology, and microfluidics, expanding your expertise in a truly collaborative setting.
• Growth Opportunities – A fast-growing startup environment with significant autonomy, ownership, and influence over best practices in the intersection of biotech and robotics.
• Innovative Culture – Join a team that prioritizes continuous learning, rigorous engineering and scientific standards, and bold problem-solving.

If you're excited about revolutionizing automation in organoid engineering and biotech—while pushing the boundaries of robotics, AI, and advanced systems—let’s connect! Please submit your resume and a brief statement of interest. We look forward to exploring the opportunity together.

Vivodyne, Inc. is an equal opportunity employer. Vivodyne complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.