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Rigel Pharmaceuticals jobs

- 423 jobs
  • Director, Quality Assurance Compliance

    Rigel Pharmaceuticals, Inc. 4.2company rating

    Rigel Pharmaceuticals, Inc. job in South San Francisco, CA

    Job Description The Director, QA Compliance, is responsible for ensuring Rigel's GxP compliance across GMP, GCP, GLP, and GPvP domains. This role oversees the internal audit program, inspection readiness activities, and complaint management processes. The Director interfaces closely with Medical Affairs, CMC, Regulatory, Clinical Operations, Pharmacovigilance, and the Call Center. This position drives continuous improvement in quality systems and maintains alignment with global regulatory expectations. Salary Range: $196,000 to $235,000 ESSENTIAL DUTIES AND RESPONSIBILITIES: • Lead Rigel's vendor/supplier audit program, while this role is not expected to lead every audit conducted by Rigel, serving as an Audit Lead is an important element of this role. Lead Rigel inspection and partner audit readiness activities for GxP areas • Lead Rigel complaint management program to ensure effective tracking, investigation, escalation, resolution, reconciliation, and trending of product complaints. Drive collaboration between QA, CMC/Technical Operations, Medical Affairs, Pharmacovigilance, and the Call Center. • Ensure completeness, accuracy, and appropriate escalation of product complaints, identify and drive CAPAs, when appropriate. • Analyze and present complaint data at Rigel Safety Committee. • Serve as QA representative for post-market quality activities, ensuring alignment between GMP and GPvP systems. • Manage Rigel Quality Escalation process: setting up and facilitating quality review board or equivalent governance meetings • Lead Rigel inspection readiness efforts and oversee inspection response management. • Partner with Rigel Clinical Operations to drive adherence to Good Clinical Practice (GCP) guidelines and regulatory standards through activities like audits, SOP development, Quality Agreements implementation, etc. • Monitor compliance metrics and identify trends to inform risk-based quality improvements. • Ensure global regulatory changes are evaluated and integrated into Rigel's QMS. • Provide training and compliance guidance to QA and cross-functional teams. KNOWLEDGE AND SKILL REQUIREMENTS: • Bachelor's degree in scientific discipline. • 12+ years of pharmaceutical QA experience with focus on compliance, audits, and complaint management. GMP and GCP experience is desired. • Comprehensive understanding of FDA, EMA, and ICH regulations for GMP, GCP, and GPvP. • Experience managing complaint and CAPA systems, and supporting regulatory inspections. • Strong analytical and organizational skills with attention to detail. • Excellent communication and stakeholder management skills across technical and non-technical teams. • Demonstrated ability to lead continuous improvement and compliance initiatives. WORKING CONDITIONS: PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk, sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
    $196k-235k yearly 13d ago
  • Director, Commercial & Promotional Analytics

    Rigel Pharmaceuticals, Inc. 4.2company rating

    Rigel Pharmaceuticals, Inc. job in South San Francisco, CA

    Job Description Director, Commercial and Promotional Analytics will be responsible for leading the strategy, design, and execution of commercial and promotional analytics to drive evidence-based decision making across Rigel's commercial portfolio. This role combines advanced analytics, business acumen, and strategic partnership to optimize brand performance, promotional effectiveness, and investment allocation. The role will have direct ownership of complex cross-functional analytics projects supporting Commercial Strategy, Marketing, and other partners across the Commercial organization. Salary Range: Premium NY/CA $217,000 to $260,000 National: $196,000 to $235,000 ESSENTIAL DUTIES AND RESPONSIBILITIES: Strategic Insights and Brand Performance Lead development of data-driven insights to inform brand, franchise, and commercial strategy. Partner with Marketing and cross-functional partners (including Market Access) to establish annual business analytics plans. Oversee KPI and performance tracking dashboards to evaluate market trends, brand health, and promotional effectiveness. Design and execute analytics projects including HCP and patient segmentation, customer journey analyses, support of the forecasting team, and sampling optimization. Collaborate on New Product Planning to assess market opportunities, competitive dynamics, and patient populations for pipeline and early-stage assets. Develop pre-launch analytics frameworks to inform go-to-market planning, resource allocation, and launch readiness assessments. Synthesize complex data into actionable insights that drive strategic recommendations for leadership. Promotional and Advanced Analytics Develop and maintain Marketing Mix models to measure and optimize promotional ROI across channels. Partner cross-functionally to define and monitor campaign performance metrics. Integrate advanced analytics capabilities (AI, machine learning, predictive modeling) to identify opportunities for dynamic targeting and next-best action. Partner with Data Operations to evaluate and implement new data sources (e.g., IQVIA, Symphony, MMIT, EMR, Lab data) and methodologies to enhance commercial decision-making. Support launch readiness efforts by providing insight into field deployment, promotional investment optimization, and launch KPI tracking. Collaborate with Forecasting and Brand leads to inform launch performance projections and scenario planning. Leadership and Collaboration Serve as a strategic thought partner to leaders across Commercial Strategy, Marketing, and other commercial teams. Translate analytical findings into clear, compelling narratives for executive stakeholders. Manage external analytics and consulting partners to ensure high-quality project delivery. Represent Commercial Analytics in cross-functional planning processes and business reviews. Partner closely with cross-functional Launch Teams and New Product Planning to align analytics deliverables with early commercial strategies, ensuring data-driven launch readiness. KNOWLEDGE AND SKILL REQUIREMENTS: Bachelor's degree in a quantitative, business, or healthcare-related field (e.g., Economics, Statistics, Business, Life Sciences). 10-12+ years (Director) of experience in commercial analytics, marketing science, or business insights within the biopharmaceutical industry. Demonstrated ability to synthesize diverse data sources into strategic guidance and actionable insights. Expertise with pharmaceutical data assets (IQVIA, Symphony, MMIT, SHA, EMR, Lab data). Advanced proficiency with analytical and visualization tools (Excel, Tableau, Power BI, SQL, Databricks). Strong business acumen, communication, and influencing skills. MBA or Master's degree preferred. Understanding of rare disease, oncology, payer and managed market dynamics is a plus. Experience supporting New Product Planning, launch analytics, or early commercial strategy is highly desirable. Management of external vendors. WORKING CONDITIONS: PHYSICAL DEMANDS: While performing the duties of this job, the employee is required to stand, walk; sit; talk and hear. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and the ability to adjust focus. WORK ENVIRONMENT: The noise level in the work environment is usually moderate. Some travel may be required. Rigel Pharmaceuticals, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
    $196k-235k yearly 28d ago
  • Strategic Insights & Business Optimization Data Analyst

    Genentech 4.5company rating

    South San Francisco, CA job

    At Roche/Genentech, we have a bold Pharma Strategy to deliver 20 transformative medicines addressing diseases with the highest societal burden. With this top of mind, Portfolio Strategy & Delivery's (PSD) purpose is to translate Roche strategies into PD priorities and deliver PD's portfolio with excellence. We want you to join our vision and be part of our talented global PSD community! We are a strong, close, trusting community that operates from a creative mindset. We provide an environment where talent can thrive and feel valued. Our organization focus is on prioritized, high impact work; customers draw on our expertise to help them deliver PD's priorities with excellence. As a Strategic Insights & Business Optimization Data Analyst, you will be responsible for supporting the team in preparing and delivering business analytics and insights, including data management activities related to the insight delivery. Accountabilities for you as an individual contributor include, but are not limited to, a combination of the following areas: Strategic Insights Generation You will collaborate with the SIBO team to collect analytics requirements, translate into specifications and delivery outputs in a timely manner using an iterative approach You will be responsible for analytical reports: develop, maintain and update a pipeline process that allows for a streamlined, easy to update manner. This includes the use of Business Intelligence tools to generate standard reports that can be customized (and eventually self service) You will handle a pipeline of requests for frequent analytics related to business performance/management, including agile project management, risk register and a dev/val/prod approach; you will provide key insights to internal partners. Advanced Data Analytics/Data science You will design and deliver advanced analytics solutions, including predictive modelling (e.g. forecasting and regressions), machine learning, and uncertainty analyses, Apply descriptive and inferential statistical methods to uncover trends, patterns, and actionable insights from large, complex datasets. You have a high level of proficiency with LLM, GenAI and developing multi-modal Agentic AI agents which would be used in the workplace to augment the analysis and reporting capabilities. You will own the end-to-end delivery of analytical solutions, from ideation to implementation, ensuring that they align with strategic priorities and stakeholder needs. You will manage and update tools and resources with the latest industry information to ensure accuracy and relevance. Collaboration and Consultation You will provide advice to the team on analytics architecture, infrastructure and improved pipeline processes as well as delivery. You will collaborate with the SIBO team to continuously improve on visualization of analytics, design of reports/dashboards and storytelling components. Data Curation and Stewardship You will acquire, aggregate, and curate high-quality primary and secondary data sources to enable accurate and meaningful analyses. You will act as the technical point of contact between SIBO and Informatics teams or Product Owners of data/insights sources. You will collaborate with other team members to pull in insights from primary and secondary data, to continuously improve forecast methods and accuracy. Continuous Improvement and Innovation You will stay up-to-date with emerging analytics methodologies, tools, and technologies to maintain a cutting-edge approach. You will regularly adapt plans and deliverables to focus on activities that deliver the highest value. You will identify opportunities to improve organizational processes, deliverables, and efficiencies, focusing on outcomes that bring the highest business value. Enterprise Mindset You will align individual responsibilities with the broader goals of the organization, emphasizing a “One Pharma” perspective. You will provide inputs for designing the right measures, &/or improve metrics, analytics and visualizations to generate evidence for business insights that enable operational efficiency and optimal decision-making with targeted communications. You will develop a deep understanding of our data sources and their systems through interacting with business & IT colleagues to design and maintain data models that allow us to measure performance and comprehend performance drivers for different areas of the business; you will help drive a culture of excellence. Who You Are: (Required) You have a Bachelor's in computer science, data analytics, data science and/or its equivalent with 7+ years of work experience, preferably in the life sciences industry or management consulting; or you have a Masters in computer science, data analytics, data science and/or its equivalent with 5+ years of work experience, preferably in the life sciences industry or management consulting; or a PhD in computer science, data analytics, data science and/or its equivalent with 3+ years of work experience, preferably within pharmaceutical or biotech industry (commercial or clinical) and/or management consulting. You have a high level of proficiency in at least two of the following areas: Data Analytics, Advanced Data Analytics, Resource Forecasting and Management, Statistics, Information Visualization, Data Science, Patient and/or Investigator Insights, and/or Competitive Intelligence. You are proficient in scripting, statistical programming, and visualization languages, such as: Python, R, SQL, Julia, Plotly, or other similar tools. You are proficient in data analytics toolkits and platforms, such as: Matlab, SAS, BI tools (Tableau, PowerBI, etc), spreadsheet software (Google Sheets, Excel), version control and collaborative tools (Git). You have demonstrated the ability to translate data into actionable insights and craft compelling narratives. Preferred Qualifications You have the ability to leverage sophisticated techniques and tools beyond traditional data analysis; you have the ability to discover deeper insights, generate recommendations, and make predictions. You have a solid understanding of the advantages and limitations of different analytical approaches. You have a considerable level of experience in exploratory and confirmatory data analysis techniques that drive strategic business decisions. You are skilled in independently or semi-autonomously examining data or content to uncover insights. You have a proven track record of effectively working in a matrix environment, collaborating with international team members (scientific, business, and operational) and using influence without authority. You are skilled at integrating data sets from diverse sources and presenting findings in various formats and mediums. You have strong written and verbal communication skills, capable of simplifying and presenting complex concepts. You have demonstrated a strong attention to detail. This position is based onsite in South San Francisco, USA. Relocation benefits are not being offered for this position. The expected salary range for this position based on the primary location of San Francisco, CA is $150,000 - $280,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $150k-280k yearly Auto-Apply 7d ago
  • Performance Excellence Delivery Lead

    Genentech 4.5company rating

    Oceanside, CA job

    At Roche, we are committed to delivering greater benefits to our patients. To achieve this, we are seeking a hands-on Operational Excellence expert to drive breakthrough performance improvements and build long-term capabilities. This role is about delivering step-change improvements, not just marginal gains, by embedding structured, data-driven methodologies that enhance efficiency, quality, and overall operational performance. As a member of the Performance Excellence Delivery team within our Pharmaceutical Global Operational Excellence organization, you will work with site teams, integrating traditional Lean principles with cutting-edge digital solutions to drive true transformation. Our Holistic and well-defined Breakthrough Methodology follows four key steps: Diagnose, Design, Implement, and Sustain, ensuring a structured and lasting impact. This is a role for a true impact driver, someone who thrives in hands-on environments, collaborates closely with teams, and is passionate about accelerating performance and creating tangible, sustainable results. The Opportunity On-Site Performance Improvement - Partner with local teams to identify and implement measurable and sustainable operational enhancements Breakthrough Performance Gains - Lead structured initiatives that go beyond incremental changes, driving significant improvements in quality, efficiency, and productivity Sustainable Capability Building - Coach and develop teams to adopt best-in-class methodologies, embedding long-term operational excellence Systematic, Data-Driven Approach - Apply proven frameworks to ensure measurable, repeatable success Leveraging Digital for Operational Improvement - Utilize digital tools and data analytics to accelerate efficiency gains and optimize end-to-end processes Cross-Functional Collaboration and Change Leadership - Engage with all levels of the organization to drive alignment, secure buy-in, and foster a culture of continuous improvement Performance Monitoring & Long-Term Impact - Define and track key performance indicators to ensure initiatives deliver lasting business value, not just short-term fixes. Who You Are Bachelor's degree and a minimum of 8 years of related/relevant experience; or an advanced degree with 6 years of equivalent work experience. Extensive experience in pharmaceutical manufacturing or related field, with a focus on sterile environments (Highly preferred). Proven expertise in Lean methodologies and leading structured performance improvement initiatives. Demonstrated success in delivering transformational impact (step-change improvements), not just incremental changes, in operational environments. Demonstrated ability to synthesize complex information and data sets, extract actionable insights, and craft compelling presentations that drive decisions. Experiences in top consulting firms (Highly preferred). Locations This is a primarily on-site role in Oceanside. Relocation benefits are available for this position. The expected salary range for this position based on the primary location of Oceanside is $120,400 and $224,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $120.4k-224.7k yearly Auto-Apply 44d ago
  • Director, Field Medical Integrated Enablement & Engagement Process Lead (EPL)

    Genentech 4.5company rating

    California job

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. The Opportunity The Director, Integrated Enablement & Engagement Process Lead (EPL) is a critical member of the Field Medical team, collaborating with the US Medical Digital team. This individual is instrumental in defining, aligning, and embedding digital, data, and analytics capabilities to not only meet current business needs but also proactively address and anticipate future needs. Acting as a key connector and central liaison between Field Medical and product teams, this role provides strong user understanding, workflow expertise, and product ecosystem knowledge to effectively embed tools within a complex, matrixed organization. Simultaneously, this role coordinates directly with users to drive successful user adoption of new digital capabilities and initiatives. This role plays a strategic part in identifying business needs, shaping product direction and prioritization, and integrating products into new and existing workflows to maximize impact in Field Medical. Furthermore, this role drives the planning and execution of change management, knowledge sharing, training, and adoption, as well as understanding and measurement activities, in partnership with Operational Excellence teams. This role requires a deep understanding of Field Medical priorities, standards of excellence, compliance, and the ability to intuitively manage, inspire, and build trust within a matrixed organization. Key Responsibilities Strategic Liaison & Stakeholder Engagement: Serves as the primary point of contact for Field Medical capability needs, collaborating with cross-functional stakeholders to identify, synthesize, and prioritize user feedback, and ensuring end-to-end excellence across Field Medical digital and AI initiatives. Workflow Design & Process Integration: Accountable for seamless integration of new digital products into workflows, serving as a subject matter expert to identify capabilities, validate requirements, and lead process changes to optimize workflows. Enablement & Support: Develops and implements strategies to drive awareness and adoption of new tools, champions change management, and designs and delivers comprehensive training. Change Leadership & Continuous Improvement: Leads complex change initiatives, drives organizational change from current to future state, and continuously partners with stakeholders to ensure alignment on priorities. Measurement & Optimization: Regularly assesses and reports on the health of Field Medical operations, collaborates with partners to establish KPIs, and synthesizes measurement insights and user feedback into actionable learnings. Compliance & Governance: Establishes robust project governance frameworks, ensures adherence to regulatory compliance and privacy standards, and builds relationships with legal and compliance partners. Who you are Qualifications & Experience Bachelor's degree A minimum of 8 years of work experience, with at least 6 years of experience in the pharmaceutical or biotech industry, including 2 years in Healthcare Business Analytics. Experience in machine learning, deep learning, AI techniques, and building impactful data visualizations for medical decision-making (e.g., using Spotfire , Tableau, and RShiny). Strong data proficiency with a deep understanding of data strategy, technology, and platforms. Strong ability to work across functions in matrixed environments, providing strategic guidance, engaging stakeholders on data and visualization needs, and influencing senior leadership without direct authority. Experience with sole ownership of tactics or pieces, ability to articulate business problems, identify solutions, and own content development from strategy through execution. Demonstrated experience with strategic planning, prioritizing, and management of high-level initiatives and projects. Strong understanding of the healthcare landscape and customer types (health systems, payers, providers, HCPs, patients, IDNs, distributors, pathways), and how they operate their businesses. Preferred Qualifications & Experience MBA or other related graduate-level degree 5+ years of experience in clinical development with strong skills in clinical trial data analysis, RWD assets. Six sigma, PMP, or similar certifications Proven ability to embed products, embrace agile methodologies, and effectively organize for impactful outcomes, while continuously investing in personal development. Demonstrates an enterprise and execution mindset, thriving in ambiguous, transformational environments with adaptive and critical thinking. Exhibits inspiring, visionary, customer-first leadership, strong business acumen, excellent presentation, interpersonal, and communication skills, alongside highly proficient project planning and oversight. Location & Travel Requirements The role is field-based, with a minimum of 30% of the time expected to be spent in the office in South San Francisco, CA, or traveling to locations designated by the Business. The expected salary range for this position based on the primary location of South San Francisco, CA is $136,100 - 252,700. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Relocation benefits are not available for this job posting Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $136.1k-252.7k yearly Auto-Apply 60d+ ago
  • 2026 Summer Intern - BRAID DELTA Lab

    Genentech 4.5company rating

    South San Francisco, CA job

    Genentech, a leader in biotechnology, is seeking an outstanding machine learning intern to contribute to cutting-edge research at the Deep-Learning Theory and Algorithms (DELTA) lab within the Biology Research | AI Development (BRAID) department. Our lab is dedicated to advancing machine-learning research to support drug discovery and target discovery efforts, with a focus on foundation models and representation learning, particularly in the realms of graphs, sequences, and multimodal data. We are committed to driving innovation through cutting-edge ML methods with real-world impact in the drug discovery field. This internship position is located in South San Francisco, on-site. The Opportunity Drive research on foundational AI methods for scientific problems, with a specific focus on generative modeling, AI agents, and LLMs applied to biological reasoning and discovery. Lead the design and implementation of novel, cutting-edge ML methods with applications to drug discovery and target discovery. Collaborate closely with cross-functional teams across gRED to tackle complex problems. Program Highlights Intensive 12-weeks, full-time (40 hours per week) paid internship. Program start dates are in May/June (Summer) A stipend, based on location, will be provided to help alleviate costs associated with the internship. Ownership of challenging and impactful business-critical projects. Work with some of the most talented people in the biotechnology industry. Who You Are Required Education Must be pursuing a PhD (enrolled student). Required Majors Computer Science, Computer Engineering, Computational Biology. Required Skills: Enrolled in a PhD program where your core focus is on machine learning, artificial intelligence, computational theory, or a related field. Strong publication record at top-tier ML venues such as NeurIPS, ICML, ICLR, AISTATS, ACL, EMNLP, etc. Excellent knowledge of the theory and practice of deep learning. Familiarity with generative modeling methods, AI agents, and/or LLMs. Excellent Python and PyTorch programming skills, with extensive knowledge of the best practices of software engineering, data engineering, and MLOps (e.g., familiar with code version control, high-performance compute infrastructures, and machine learning experiment monitoring workflows). Preferred Knowledge, Skills, and Qualifications Excellent communication, collaboration, and interpersonal skills. Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. Knowledge and experience with LLM reasoning, model post-training, and/or reinforcement learning. Familiarity with biological applications such as sequence design, perturbation biology, and/or target discovery. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of California is $50.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $50 hourly Auto-Apply 2d ago
  • SAP System Process Specialist (CVRM)

    Genentech 4.5company rating

    California job

    ITOT supports Pharma Technical Manufacturing (PTM), PTM is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. ITOT will own and operate Manufacturing Technology stack at the site working with Global IT. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). The Opportunity A System Process Specialist is being hired to participate in Greenfield Project execution and then support the facility after going live. The role will become member of SAP deployment team for Holly Springs and post go live become site first level support. Candidate will bring experience from one or more of following L4 business processes: EWM (Warehouse), Make, Plan, Asset, Quality Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. What You'll Do A Systems Process Specialist acts in the 1-Stop-Shop and is part of the support, continuous improvement and onboarding and adoption value streams. The Systems Process Specialist has a profound process understanding and is collaborating with the Business Support Community to continuously improve business processes and underlying IT applications. By this, he/she acts as a trusted adviser of the end-user for any kind of inquiry as well as a bridge between the end user and other roles in the various support layers and can raise incidents on behalf of the user area or work with managers to train users . The role is specialist on a specific operation process area and is providing end-user support based on in-depth and long time professional experience in this domain. Examples of domains include Plan, Make, Quality, EWM (Warehouse), Assets etc. In projects the Systems Process Specialist can also represent the interests of the systems user group and has the responsibility of coordinating and bringing input from the area of responsibility to the project and communicating project goals, information and progress back to the business areas. End User Operation Support Performs Level 1 On Site/Remote support and troubleshooting of applications, primarily focused on SAP R3 and ASPIRE but could expand to PI, MES, etc. Acts as Point of Contact for End User/business stakeholders in terms of business requests and IT related issues. Triages, prioritizes requests and tries to identify the nature / root cause of an issue (handling issue, data issue, authorization issue, IT issue). Distributes application issues and non-application issues that cannot be solved by him/her to the 2nd level and/or Global Team support. Coordinates end user groups and escalation management. Follows up on IT Service tickets to resolve issues in a timely manner. Supports issue clarification on request of 2nd level and/or Global Team support. Validates the resolution proposals and performs the necessary test in case tests are required. Cooperates with 2nd level and/or Global Team support during analysis of reported incidents. Maintains close coordination and communication with End User/site business stakeholders for major incidents. May be a role owner for local roles. Performs interface monitoring (business errors). Executes complex or critical system actions. For new IT initiatives/product/system roll out/Go Live to site, provides on site/remote on call support per business requirement such as adopting business shift pattern during initial roll out and stand down to remote On Call post Hyper Care after successful roll out. Supports Global/Enterprise and Local ITOT application/systems. Supports site audits and inspections, planned/unplanned events, and implementation of corrections, etc. as a Subject Matter Expert. Provides 24x7 routine operation service support per Service Level Agreements to business. Adheres to the requirements specified in IT related Roche's quality policies/quality standards or related SOP. Continuous Improvement Supports/Leads Continuous Improvement opportunities related to ITOT applications/system. Regular exchange with the Support network and or BPMs on support cases, best practices and process improvement proposals with network relevance. Helps the End User to submit new ideas for process improvements, allowing a comprehensive approach for assessing both the process interdependencies as well impact to all underlying systems. Describes the full lifecycle of an integrated Change process to Business Process with System impact. This Framework combines the Assessment of the requirement, Build and Test work as well as Deployment and eventually delivery of the added value to the End User. Embodies PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives. Onboarding & Training Coordinates and conducts End User training. Supports user authorization workflows (e.g. request, verify training, approve). Adds information to the knowledge base. Creates/Reviews Knowledge Articles. Creates/Reviews training material. Initiates knowledge management process. Who You Are Bachelor's degree in Informatics, Engineering, or equivalent. 5+ years of experience with SAP R3. Experience or familiarity with ASPIRE is a plus. Must have experience in biotech/pharmaceutical manufacturing GMP domain. Knowledgeable about integration with enterprise business systems (SAP, MES, LIMS, etc.) and data integrity concepts. Soft Skills Strong analytical skills for effective troubleshooting and problem solving. Candidates must be self-driven and able to work well with others as a team member. Strong technical writing and verbal communication skills. Excellent customer service skills and delivery through agile mindset, stability, flexibility, and speed. Passion for learning and sharing/leveraging best practices. Eager to explore new technology and have the ability to learn new concepts. Relocation Funding is not available for this role. The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $80,500 - $149,500. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $80.5k-149.5k yearly Auto-Apply 49d ago
  • Principal Human Factors Engineer

    Genentech 4.5company rating

    South San Francisco, CA job

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche! The Opportunity The Principal Human Factors Engineer will be responsible for providing human factors engineering expertise to project teams developing combination product drug delivery devices for parenteral pharmaceutical therapeutics at Genentech, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered. The Principal Human Factors Engineer has strong experience in human factors engineering for combination products and/or medical devices. They will collaborate with multifunctional teams including device engineering, regulatory, clinical, quality, marketing, and program management to inform and guide development of innovative products and ensure that those products are safe and easy to use. The candidate has demonstrated ability to lead project-level human factors activities, including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and design validation studies. They will also develop instructions for use and training materials for clinical trial and commercial purposes. The Principal Human Factors Engineer will be assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems. The candidate will work with limited direction and may provide guidance and coordinate work activities of other personnel and may also supervise staff members. The work is reviewed with a focus on long-term perspectives, as the Principal Human Factors Engineer establishes his/her own work priorities and timelines. Who you are Education and Industry Experience: B.S, M.S, or advanced degree in human factors engineering, cognitive psychology, industrial engineering, bioengineering, or related discipline. At least 8 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelor's degree. In depth experience in writing technical documents, analyzing data, writing usability study protocols, performing statistical data analysis and writing summary reports is expected. Technical Knowledge: Strong skills in relevant modeling and design tools, design controls and/or data analysis. For example: Ability to generate and analyze large data sets, including quantitative and qualitative analysis Advanced knowledge of design controls and relevant human factors standards and guidances Development of product training and instructions for use, design and execution of formative and summative usability studies, use-related risk analysis, and other human factors methods Interpersonal Skills: A proven track record of working effectively in a matrixed organization with a highly cross-functional (e.g., device development, regulatory, clinical, quality, and program management) and collaborative environment is very desirable. Excellent communication skills are required. Experience in working with external partners is also highly desirable. Highly organized and detail oriented. Excellent leadership skills. Relocation benefits are available for this job posting. The expected salary range for this position based on the primary location of South San Francisco, CA is $109,500 - $203,300. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $109.5k-203.3k yearly Auto-Apply 32d ago
  • 2026 Summer Intern - Product Technical Development - Laboratory (Wet-Lab or Dry-Lab)

    Genentech 4.5company rating

    South San Francisco, CA job

    To Apply: As a second attachment (apart from your CV), please include a cover letter (not to exceed 1 page in length) that addresses the following questions: What strengths are you most proud of that you will bring to your role as an intern at Genentech? How does interning at Genentech fit in with your long term career goals? Please describe a unique situation in either your academic, personal, or career areas of your life in which you took initiative that had a meaningful impact on either your school, community, or an organization. Department Summary Pharmaceutical Technical Development (PTDU) develops, delivers, and supports robust, cost-effective production methods and technologies for innovative therapeutics to meet the needs of Genentech's Research, Development, Commercial, and Product Operations groups. The group has long been recognized as a world leader in developing large-scale manufacturing processes, sophisticated analytical methods, and effective drug delivery systems. This internship position is located in South San Francisco, on-site Program Highlights Six Months (with a possible 6-month extension), (40 hours per week) paid internship. Program start dates are in May/June 2026. A stipend, based on location, will be provided to help alleviate costs associated with the internship. Ownership of challenging and impactful business-critical projects. Work with some of the most talented people in the biotechnology industry. Final presentations of project work to senior leaders. Lead or participate in intern committees to design and coordinate program events and initiatives. Professional & personal development curriculum throughout the program, including networking opportunities, workshops, and panel discussions. Participate in volunteer projects, social events, and team-building activities. The Opportunity As a Technical Development Intern, Laboratory focus, you may be assigned a project in one of the following areas within PTDUP: Cell Culture and Fermentation Development Purification Development Protein Analytical Chemistry Analytical Operations Pharmaceutical Development Drug Delivery Technology Development Potency Assay Development Cell and Gene Therapies This program provides a broad perspective and appreciation of the development of new processes, methods, and technologies at different production scales in the biotechnology industry. Candidates applying for the PTDU Intern Program should be passionate about science/engineering and thoroughly enjoy the challenges associated with complex problem-solving. Candidates must be highly self-motivated and able to work effectively as individuals and as part of multi-disciplinary teams in an atmosphere of casual intensity to develop medicines for unmet medical needs. Interns with a laboratory focus will work alongside scientists to design, execute, and analyze wet-lab or dry-lab-based experiments in support of the diverse development activities needed to produce therapeutics at scale for patients. Previous internship projects have included but are not limited to: Cell and molecular biology approaches to develop novel drug potency assays. Bioreactor, fermentation, and cell culture media studies. Drug analysis using tools like mass spectrometry, HPLC, NMR Protein structure and stability studies. Developing cell differentiation protocols in support of cell therapy programs. Updates to the PTDU Assay Information & Request (PAIR) System. Benchling templates and results schema update. Required Education You meet one of the following criteria: Must be pursuing a Bachelor's degree (enrolled student graduating in 2026 or 2027). Must have attained a Bachelor's degree no more than 2 years ago from the time of application (not currently enrolled in a grad program). Must be pursuing a Master's degree (enrolled student). Must have attained a Master's degree no more than 2 years ago from the time of application. Required Majors: Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Bioengineering, Pharmaceutical Engineering, Chemistry, Biology, Microbiology, Biophysics, or related disciplines. Preferred Knowledge, Skills, and Qualifications Detail-oriented, enthusiastic, and self-directed individual who is excited about tackling complex and creative scientific challenges in an industrial setting. Excellent communication, collaboration, and interpersonal skills. Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. Ability to show a high degree of adaptive capacity. Relevant work experience in research labs or the biotechnology industry. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location for this position in California is $30.00 - $40.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $30-40 hourly Auto-Apply 4d ago
  • 2026 Summer Intern - Computational Sciences Center of Excellence - Agentic tool for Optical Pooled Screens

    Genentech 4.5company rating

    South San Francisco, CA job

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Advances in AI, data, and computational sciences are transforming drug discovery and development. Roche's Research and Early Development organisations at Genentech (gRED) and Pharma (pRED) have demonstrated how these technologies accelerate R&D, leveraging data and novel computational models to drive impact. Seamless data sharing and access to models across gRED and pRED are essential to maximising these opportunities. The new computational sciences Center of Excellence (CoE) is a strategic, unified group whose goal is to harness this transformative power of data and Artificial Intelligence (AI) to assist our scientists in both pRED and gRED to deliver more innovative and transformative medicines for patients worldwide. Within the CoE organisation, the Data and Digital Catalyst organisation drives the modernisation of our computational and data ecosystems and integration of digital technologies across Research and Early Development to enable our stakeholders, power data-driven science and accelerate decision-making. This internship position is located in South San Francisco, on-site. The Opportunity The XY and Li Labs are seeking a PhD intern with deep expertise in AI Agent architectures to advance our capabilities in Optical Pooled Screens (OPS). Our teams have developed high-performance internal computational frameworks to process terabytes of OPS data. However, optimal execution of these pipelines currently relies on complex, manual configuration by domain experts. We are looking for a researcher to build an autonomous agentic system capable of driving these internal tools. The goal is to move from "human-in-the-loop" operation to a fully autonomous reasoning engine that can optimize data processing strategies on the fly. Key Responsibilities: Architecture: Design a modular Python-based agent capable of "tool use" (invoking internal binary executables and APIs). API & Documentation: Build a production-grade interface for the agent. You must prioritize clear, standard communication protocols to ensure the agent can be easily integrated into broader multi-agent workflows. Benchmarking: Establish a rigorous evaluation framework to quantify the agent's ability to converge on optimal processing configurations compared to human experts. Project Scope Autonomous Pipeline Optimization: Design an agent capable of utilizing our internal OPS CLI and Python tools. The agent must autonomously test hypotheses on raw image data to determine optimal parameters for image stitching, registration, and feature extraction. Agentic Reasoning & Recovery: Implement a robust reasoning loop (e.g., Plan-and-Solve, ReAct) that can interpret structured quality control logs. The system should effectively diagnose failure modes-distinguishing between data anomalies and configuration errors-and self-correct without human intervention. Interoperable System Design: A critical requirement is the ability of this agent to exist within a larger automated ecosystem. You will design and implement a well-documented, standard API (REST/OpenAPI) for the agent. This interface must allow third-party orchestrators or other specialized agents to communicate with your system, submit jobs, and negotiate parameters programmatically. Program Highlights Intensive 12-weeks full-time (40 hours per week) paid internship. Program start dates are in May.18 2026 A stipend, based on location, will be provided to help alleviate costs associated with the internship. Ownership of challenging and impactful business-critical projects. Work with some of the most talented people in the biotechnology industry. Who You Are Required Education Must be pursuing a PhD (enrolled student). Must have attained a PhD. Required Majors Computer Sciences, Data Sciences, Artificial Intelligence, Machine Learning, Applied Mathematics, Applied Physics, Computational Biology, Biomedical Engineering, Bioinformatics, Data Engineering. Required Skills Advanced Expertise in AI Agents: You are currently researching or building complex agentic systems. You have deep knowledge of orchestration frameworks (e.g., LangGraph, AutoGen), state management, and tool-calling patterns. Strong Software Engineering: Expert Python system designer with experience in Model Context Protocol (MCP) and Agent Communication protocol (ACP) implementation. Data Fluency: While biological expertise is not required, you must be comfortable working with high-dimensional data and complex optimization landscapes. Collaborative Mindset: Ability to work at the intersection of two labs, translating computer science concepts into practical solutions for biological discovery. Preferred Knowledge, Skills, and Qualifications Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of California is $50.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $35k-42k yearly est. Auto-Apply 2d ago
  • Sr. Contract Recruiter

    Neurocrine Biosciences 4.7company rating

    San Diego, CA job

    Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role:Do you have a knack for identifying top-tier talent and a passion for recruiting? Are you ready to make a significant impact within the dynamic and innovative environment of a leading biopharmaceutical company? If so, Neurocrine Biosciences is looking for you! As our Senior Contract Recruiter, you will be a strategic partner to hiring managers, tasked with sourcing, assessing, and securing top talent for a variety of roles in the pharmaceutical space. You will leverage your deep understanding of the industry, technical acumen, and best practices to enhance our talent acquisition strategy and elevate our company's growth trajectory. _ Your Contributions (include, but are not limited to):Your Contributions (include, but are not limited to): Act as a strategic partner to hiring managers, defining, refining, executing, and communicating search strategies tailored to specific job requirements Collaborate closely with hiring managers to understand business needs, define unique search parameters, and provide market insights Specialize in technical recruiting, leveraging your expertise to source and attract candidates for commercial pharmaceutical roles Analyze industry, products, and geographical trends to inform talent acquisition strategies and determine optimal recruiting sources Promote the company image to candidates and external service providers, ensuring a positive and engaging candidate experience Work with agencies, recruiting contractors, and third parties to conduct targeted employment advertising campaigns Assist with the immigration process and act as a liaison with immigration attorneys when necessary Identify critical skills and roles in partnership with leaders, building a proactive pipeline for future hiring needs Manage applicant flow meticulously, ensuring timely review, disposition, and advancement of resumes Facilitate and participate in candidate interviews and the selection decision process Partner with hiring managers to define interview team roles and focus areas using both technical and behavioral interviewing models Provide regular updates to the Talent Acquisition team, hiring managers, and business partners Participate in the selection of external search partners, as necessary Collaborate with HRBPs, the compensation team, and hiring managers to make job offer recommendations, secure necessary approvals, and extend offers to candidates Assist with the creation and enhancement of special programs and initiatives, such as employee referral programs, brand recognition improvement, interviewer training, and diversity and inclusion initiatives Other duties as assigned Requirements: BS/BA degree in Business, Human Resources, or a related field 6+ years of relevant experience within the Pharmaceutical/Biotechnology industry Developing reputation inside and outside the company related to expertise Excellent computer skills, communication, problem-solving, and analytical thinking skills Ability to see the broader picture and understand the impact on multiple departments/divisions Ability to meet multiple deadlines across various projects/programs with a high degree of accuracy and efficiency Excellent project management skills Experience delivering full-cycle recruitment services Experience working and negotiating with outside search partners Experience in a fast-paced organization Proven track record in sourcing and attracting qualified candidates Expertise with sourcing such as LinkedIn or AI tools; experience using ATS systems required. Workday preferred Superior selection skills and high proficiency in assessing individuals Strong persuasion, influence, negotiation, and consultation skills Robust stakeholder management and relationship-building skills High business acumen with the ability to communicate effectively with leaders across the organization Proven ability to cultivate successful relationships internally and externally Results-driven, demonstrating success relative to established targets and metrics Exceptional emotional intelligence and decision-making skills Strong listening, facilitation, and communication skills Type of Role: Consulting, temporary assignment #LI-MM1 Requirements: Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.
    $64k-87k yearly est. Auto-Apply 10d ago
  • Associate Scientific Director, Toxicology

    Neurocrine Biosciences 4.7company rating

    San Diego, CA job

    Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role: As a scientific leader, will develop and lead Toxicology/Safety Pharmacology projects, oversee studies from planning through to final reporting. Participates in formulating the strategic and operational direction of the function ensuring all studies are conducted in line and adhere to appropriate guidelines and regulatory testing standards and individual program objectives. Recommend scientific strategies for overall programs and/or department. Represents Toxicology on Development teams and may advise senior technical leadership of Toxicology/Safety pharmacology findings and recommendations. _ Your Contributions (include, but are not limited to): Lead toxicology strategy and execution for new and existing drug candidates Design, evaluate, and manage Toxicology and Safety Pharmacology studies, including protocol development, budgeting, oversight, and reporting Analyze and interpret study data; prepare technical reports and oral presentations for internal key stakeholders Own preparation and quality control of regulatory documents (IB, IND, CTA, NDA/BLA), including annual updates and submissions Recommend and implement process improvements and SOP updates to optimize program efficiency Stay current with global regulatory guidance and proactively inform stakeholders Collaborate across multidisciplinary teams and support technical documentation and database management Mentor junior scientists, and lead/contribute to intellectual property development Lead the development of intellectual property Support additional strategic initiatives as needed Requirements: BS/BA in Toxicology, Pharmacology, Biology, or related discipline with 15+ years of experience of CRO and/or pharmaceutical industry experience, including Safety Pharmacology OR MS/MA with 13+ years OR PhD with 7+ years in similar fields and roles Extensive experience in Safety Pharmacology, Toxicology, and Pathology across small molecules, peptides, and biologics (gene therapy knowledge a plus) Proven leadership in managing preclinical CROs and regulatory submissions (IB, IND, CTA, NDA/BLA/MAA) Strong knowledge of ICH and FDA guidance Preferred Skills DABT certification preferred #LI-DM1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $170,100.00-$246,150.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
    $170.1k-246.2k yearly Auto-Apply 60d+ ago
  • Senior Principal Mechanical Engineer, Site Services

    Genentech 4.5company rating

    South San Francisco, CA job

    As a Senior Principal Mechanical Engineer at Genentech, you'll have the unique opportunity to lead the charge in designing and upgrading advanced mechanical systems for a dynamic and evolving portfolio of facilities spanning over 6 million square feet across South San Francisco, Dixon, and beyond. Acting as a technical authority, you'll drive innovative and efficient solutions for critical mechanical infrastructure, utilities, and HVAC systems that underpin Genentech's cutting-edge operations. Collaborating with cross-functional teams and industry leaders, you'll play a strategic role in shaping site standards, ensuring alignment with emerging technologies, regulatory requirements, and corporate excellence. If you're a seasoned engineer with a passion for innovation, collaboration, and pushing industry boundaries, this pivotal role offers the chance to make a lasting impact across a globally recognized organization. The OpportunityResponsibilities: The responsibilities for this position may include, but are not limited to: Under the direction of the Director of Design Engineering, the Design Engineering Senior Principal Mechanical Engineer provides technical leadership and accountability for mechanical engineering designs on capital projects and engineering services done at the South San Francisco, Dixon sites and other sites as requested. This role engages actively in the design and planning of upgrades to critical mechanical infrastructure, utilities and facility HVAC systems across a portfolio of 50+ buildings / ~6M square feet of space. This role is a respected industry expert and engages with the Roche internal and industry external network to learn, influence and collaborate on new technologies, best practices and standards, bringing this knowledge and expertise to bear so that project designs provide safe, efficient and reliable operations to Genentech customers. Project Technical Analysis & Design Guidance: The primary area of focus for this role will be supporting the execution of a portfolio of projects with technical input and technical coordination in the mechanical engineering area, including design guidance on HVAC, plumbing, fire protection, building controls, automation and energy management. The Senior Principal Mechanical Engineer will be assigned 2 - 3 large scale projects ($10M and above) and a portfolio of approximately ~20 projects at a time (ranging in size from $50K to $10M each) for which they will attend key design meetings and provide design input and technical options analysis. The projects will be executed by multi-disciplinary teams, and this role will need to align, coordinate input and influence key customers (R&D, Commercial, Pharmaceutical Technical Operations) and stakeholders (Site Operations, SHE and Security) on project designs. Project Technical Analysis & Design Guidance, continued: The Senior Principal Mechanical Engineer will also provide management and oversight of other Mechanical SMEs brought in as required to manage influx of mechanical related work. A key function of this role will also be to align the many project designs to Roche / Genentech and site specific standards, and to coordinate the scope done on these many small projects into a comprehensive strategy to address needs in this technical area across the site. Lead Mechanical Design Standard Team: SSF Design and Construction executes the design work on portfolio (less than $10M) projects using the services of three alliance engineering firms, each of whom has an assigned mechanical engineering lead. The role will lead a mechanical engineering design sub-team including the representatives of each of these three firms, along with representatives of Site Operations, Environment, Health and Safety (EH&S), and others. As defined by project needs, this team will be tasked with developing strategies for upgrading deficient areas of the campus through the project portfolio. This team may also engage in the development and review of design standards. Site Specific Standards: This role will be responsible for developing site specific mechanical design standards. Such standards will be based on Roche/Genentech corporate standards (including corporate “K” directives), but will be customized for the South San Francisco and Dixon sites. Development of site standards will involve effectively engaging, involving and influencing site leaders, site operations and customer groups, and will involve incorporating new industry technologies and concepts to advance the mechanical infrastructure of the site. Standards will be updated on a schedule agreed with management, and likely driven by upcoming portfolios of projects in a technical area for which such standards apply. This role will also be responsible for maintaining updated standards in an accessible online portal available to partner design firms and stakeholders. Technical Leadership & Industry\Network Engagement: The Senior Principal Mechanical Engineer will be the SSF site expert on industry HVAC/Plumbing, BAS trends and new technologies. As such, a key portion of the role is continuous learning, engagement with the Roche Engineering Network (technical experts within the Roche Global organization and other Roche sites) as well as outside industry organizations, including ASHRAE, ISPE and others. A portion of the role's time will be spent visiting other sites, attending (and occasionally presenting) at applicable conferences and industry events, and applying learned skills to the execution of projects at the SSF site. Technical Leadership & Industry\Network Engagement, continued: Additionally, a portion of the Senior Principal Mechanical Engineer's time will be spent supporting broad Design Engineering process improvement projects and LEAN initiatives, to improve the processes and functioning of the overall team. Strategic Partnership & Innovation: The Senior Principal Mechanical Engineer will be responsible for driving innovation across the design and construction of building systems, appropriately adopting technologies and delivery approaches which improve building systems performance, cost effectiveness, and reliability. This role will lead the development of a site-wide mechanical/electrical infrastructure strategy in partnership with Site Ops and Real Estate & Assets focusing on reducing total cost of ownership, improving performance, and ensuring current site needs are fully met while remaining adaptable to future demands. Additionally, for projects over $10M the role will work with internal and external partners to create and maintain a quality assurance and control program. This includes developing individual and team capabilities, collaborating with external partners to ensure qualified engineering resources are assigned to Genentech projects, and driving change when performance does not meet expectations. The Senior Principal Mechanical Engineer will also be the SSF site expert on industry trends and new technologies for performance-based commissioning and data analytics. Who You Are Requirements: Bachelor's degree in Mechanical Engineering or equivalent. 15 years or more pharmaceutical technology experience in industry or academia after receiving their Bachelor's Degree, at least 8 of which involved mechanical system design, construction and\or commissioning and qualification activities. Working knowledge of ANSI / ASHRAE, NEMA, NFPA, EPA, and OSHA standards as well as relevant chemical industry specific standards and documentation (piping and instrumentation diagrams, process flow diagrams). Pharmaceutical GMP project mechanical design experience, LEED certification, experience in project management, LEAN / Six Sigma certification, and/or experience working in a campus environment highly desired, but not required. Must have excellent communication (written/verbal), presentation, leadership, interpersonal, collaborative, conflict resolution, and negotiating skills Excellent organization and planning skills. Advanced Microsoft Office and Google Suite skills. Exceptional teamwork and collaboration skills are essential to facilitate the work of cross-functional and interdepartmental teams. Must be dependable, provide attention to details, and execute proficiently in coordination tasks. Self-starter and ability to work with minimum or no supervision. Relocation benefits are not available for this position. The expected salary range for this position based on the primary location of California is $159,000.00 - $295,200.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $159k-295.2k yearly Auto-Apply 60d ago
  • Senior Manager, Facilities Data & Analytics - Site Services

    Genentech 4.5company rating

    South San Francisco, CA job

    We are seeking a strategic and visionary Senior Manager, Facilities Data & Analytics to build and lead the data foundation for our Facilities & Engineering (F&E) organization. This leader will transform how we leverage data to enhance infrastructure reliability, optimize capital planning, and drive operational excellence across our building and lab equipment assets. As a member of the F&E Leadership Team, this role is pivotal in shaping and executing our long-term digital transformation.The OpportunityReporting to the Sr. Director of F&E, you will own the strategy and execution across three core pillars: Data Governance & Process: Oversee and manage a robust data governance framework for ~30,000+ assets, ensuring data quality, consistency, and accessibility across our asset management platform. Ensure processes are efficient and consistent throughout the organization. Analytics & Insights: Develop and scale a sophisticated analytics ecosystem, creating standardized reports, dashboards and predictive models that translate complex data into actionable insights for operational teams and strategic recommendations around capital investment, resource allocation and maintenance optimization for leadership. Technology & Innovation: Act as a thought leader, identifying and championing the use of emerging technologies like AI and IoT to drive initiatives in predictive maintenance, resource optimization, and data-driven capital investment. Who You AreThe ideal candidate is a proven leader with a strong technical foundation in data systems and a passion for solving business problems. You excel at managing teams of technical experts, influencing stakeholders in a complex environment, and delivering innovative, business-aligned solutions that create tangible value. Key Responsibilities Team Leadership & Development Lead, coach, motivate and develop a high-performing team of ~4 employees including data specialists and reliability analytics experts. Elevate employee engagement by fostering a collaborative, inclusive, and innovative team environment. Given the highly regulated environment, ensure services comply with OSHA, cGMP, environmental, and other regulations. Collaborate across global teams to support the development of shared tools and processes across the network. Use outcome-based planning to set and monitor team goals, ensuring alignment with departmental and organizational objectives. Ensure effective and efficient business processes are in place, leveraging agile behaviors and mindset, LEAN continuous improvement methodologies, innovation, and business metrics. Design and implement training programs to enhance team expertise in data management, SAP systems, and analytics tools. Promote a data-driven culture within the department by training leadership and teams on interpreting and applying analytics insights Data Governance Establish and enforce a consistent data governance process and master data standards across ~30,000+ assets for SSF and Dixon sites aligned with Quality and Global standards. Manage data entry requests for new and existing assets, maintenance materials (spare parts), and calibration data. Serve as a data specialist for our SAP CMMS/CCMS, overseeing data integrity and ensuring systems are continually inspection-ready and compliant with cGMP standards. Drive continuous improvement in data management processes, leveraging AI and other tools to enhance quality, consistency, and efficiency. Act as an expert in mass asset data entry, recurring and ad hoc maintenance data queries and reporting within SAP. Work across teams to align on data entry standards and behaviors which will enable analytics. Collaborate with internal stakeholders to standardize data processes and align them with enterprise-wide governance practices. Analytics & Operational Insights Direct the development of a robust analytics toolkit, including standard reporting and advanced dashboards (Tableau, SAC, SEEQ, PiVision, etc), to support operational decision-making. Lead the development and continuous improvement of business analytics tools. Partner with the F&E Leadership Team to evolve KPIs and deliver insights that drive meaningful improvements in reliability, maintenance optimization, and capital planning. Translate large, complex datasets into clear, compelling stories and strategic recommendations for senior leadership. Technology Strategy Translate strategic digital goals into actionable criteria for data management and analytics. Guide the application of AI across all phases of asset management-from initial generation of asset data through maintenance and reliability analysis to inform capital replacement. Lead initiatives such as maintenance and resource optimization, spare parts optimization and management, and predictive reliability analytics. Act as a thought leader on emerging technologies (e.g., AI, IoT) as they relate to Operations and Maintenance and evaluate their application for improving energy efficiency, reliability and resource optimization. Drive innovation by leveraging expertise across the Roche network, scaling solutions, and adopting and sharing technical best practices. Stay informed on industry trends to recommend and apply innovative technologies that drive competitive advantage Collaboration & Partnerships Effectively collaborate, partner and leverage capabilities across the organization including DS&P, our Integrated Facilities Management (IFM) provider, Design & Construction (D&C), Real Estate & Workplace Effectiveness (REWE), IT and various internal customer groups and global teams. Lead change management initiatives, effectively communicating the value of data-driven approaches to a broad, cross-functional audience. Establish and maintain a strong customer service mindset and ability to navigate complex and extensive partnerships across multiple teams. Improve team performance by regularly soliciting and integrating feedback from stakeholders, key customers, and business partners. Foster strong relationships through exemplary, timely, and consistent communication with staff, customers, and service providers. Drive superior customer satisfaction in close collaboration with senior leadership. Qualifications Experience & Education Bachelor's degree in engineering, data science, or a related field required. Masters degree in data science, statistics or engineering preferred but not required. Minimum 5 years of related analytical and business experience working with business processes and systems. Demonstrated experience in leading teams of technical experts or data specialists is required. Familiarity with facilities system assets and maintenance data preferred. Ability to solve problems autonomously with minimal guidance is required. Detail-oriented, self-motivated, results driven and self-directed while remaining a strong team player is required. Core Competencies Technical Skills Familiarity with SAP CMMS (S4 Hana) required. Familiarity with ASPIRE SAP Finance System (S4 Hana) desired. Experience developing business cases for technology and analytics initiatives, including quantifying ROI through maintenance optimization, capital deferment, and risk reduction. Experience in dashboarding and analytics/dashboarding platforms (Tableau, SAC, etc.) required. Programming experience (Python, etc.) desired. Formal training in some level of statistics and/or statistical process control required. Experience with statistics modeling software such as JMP desired. Familiarity or working knowledge of reliability metrics (Mean Time Between Failure, Mean Time to Repair, etc) desired. Stakeholder Management Excellent communicator both verbally and visually. Demonstrated ability to develop analytics tools which tell a story and drive decision-making. Able to lead change-management initiatives within an organization. Creative thinker with a pragmatic approach to innovation and continuous improvement in large, regulated organizations. This position is not eligible for relocation. The expected salary range for this position based on the primary location of California is $124,900 - $231,900 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $124.9k-231.9k yearly Auto-Apply 60d+ ago
  • Regulatory Early Talent Program - OnePDR

    Genentech 4.5company rating

    South San Francisco, CA job

    This is a temporary, 2-year contract position. Embark on a transformative two-year journey with the One Product Development Regulatory (PDR) Early Talent (ET) Program, meticulously crafted to impart comprehensive foundational knowledge in regulatory affairs. This dynamic initiative blends hands-on assignments with tailored learning solutions, making it an ideal entry-point for aspiring regulatory professionals. Participants gain invaluable insights into the complete lifecycle of pharmaceutical products, from initial clinical trials to market exit, by engaging in diverse activities across various therapeutic areas and stages of development. The latter part of the program offers the opportunity to rotate into another function or specialize further in PDR. Throughout the program, ETs collaborate with global drug development teams to support the introduction of novel pharmaceutical products to patients worldwide. This environment not only enhances their scientific writing skills but also deepens their understanding of regulatory frameworks by preparing a wide array of regulatory documents. By joining the One PDR ET Program, participants become pivotal contributors to the regulatory landscape, dedicated to ensuring that life-changing medicines reach those who need them most. The Opportunity: Delivers on projects with mentorship and actively builds foundational regulatory experience with the support of colleagues. Owns their learning and development, actively seeking to understand drug development and regulatory roles, and engaging in knowledge sharing and peer support. Responsible for understanding and applying business processes to deliver foundational regulatory deliverables. Engages with the team through active listening, practicing open communication, and building trust within regulatory and cross-functional teams. Grasps the vision of the Roche organization, understanding how their work impacts the team and contributes to overall goals. Improves prioritization and time management skills while spending significant time on-site at Roche office. Who you are: You hold a degree (B.Sc., M.Sc., or Doctorate) in a life sciences, biological sciences, biology, chemistry, pharmacy, or related field before the start of the program, and you are within two years of completion of a degree program in the before mentioned disciplines. You have a basic understanding of drug development and entry level understanding of the role of a regulatory professional. You have no more than 1-year of relevant past pharmaceutical experience. Demonstrates a learning mentality, engages in personal growth, and actively seeks and acts on feedback. Fosters partnership, collaboration, empowerment, and autonomy to build a strong community. Submit your application including your Curriculum Vitae and cover letter with responses to the following: What is your motivation to join the One PDR Early Talent Program at Roche? What technical and personal competencies would you bring along to the One PDR Early Talent Program? Additional Information: Department: Global Product Development Regulatory (PDR). Location: Based in South San Francisco, United States. Hours: Full-time (40 hours per week). Start date: April 2026 or upon agreement. Length: 2-year work term Number of Positions: 2 available in this recruitment cycle. Relocation benefits are not offered for this job. The expected salary range for this position, based on the primary location in California, is $56,800 - $105,600 USD annually. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also includes paid holiday time off benefits. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $56.8k-105.6k yearly Auto-Apply 9d ago
  • 2026 Summer Internship - External Quality

    Genentech 4.5company rating

    South San Francisco, CA job

    External Quality is responsible for the Quality and Compliance of externally sourced raw materials, supply from CDMOs, and distribution quality from Roche sites to Affiliates, including the certification for the EU market. We serve our patients through external partnerships because access to quality products is every patient's right. We leverage external partners to offer flexibility to our internal capacity at the correct cost and quality. We enable our external partners to reliably deliver compliant, quality products to our supply chain customers so that we can deliver to patients worldwide. We do this through cross-functional collaborations, ensuring quality process excellence and continuous improvement. This internship position is located in South San Francisco, on-site. The Opportunity Provide quality and compliance oversight for external GxP suppliers, including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and Quality Agreement requirements. Serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning. Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions. Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements. Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate. As applicable, manage all required activities to support Make Assess Release (MAR) of commercial medicinal products including approval of master process documentation, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance. As applicable, release, reject or quarantine commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Swissmedic and Roche requirements on behalf of the Responsible Person (RP). As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs. As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness. As applicable, manage or lead technical transfers for manufacturing, testing, packaging, and product launches. As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements. Program Highlights Intensive 12 months, full-time (40 hours per week) paid internship. Program start dates are in June 2026 (Summer). A stipend, based on location, will be provided to help alleviate costs associated with the internship. Ownership of challenging and impactful business-critical projects. Work with some of the most talented people in the biotechnology industry. Who You Are (Required) Required Education - You meet one of the following criteria: Must have attained a Bachelor's degree (recent graduates not currently enrolled in a grad program). Have attained a Master's Degree. Have attained a PhD. Required Majors: Biotechnology, Bioengineering, Chemistry, Biochemistry, Biology. Required Skills: Knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GxP suppliers. Highly competent in MS Office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc. Ability to communicate clearly and professionally both in writing and verbally. Fluency in oral and written English is a must. Preferred Knowledge, Skills, and Qualifications: Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus. Experience with GxP suppliers such as CMO, CLO, and direct material suppliers is a plus. Operational Excellence expertise is a plus. Additional language skills are a plus. Excellent communication, collaboration, and interpersonal skills. Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of South San Francisco is $33.00-$46.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $33-46 hourly Auto-Apply 7d ago
  • Portfolio Analytics Lead

    Genentech 4.5company rating

    South San Francisco, CA job

    We advance science so that we all have more time with the people we love. The Portfolio Analytics Lead in Genentech Research and Early Development (gRED) Early Clinical Development Informatics (ECDi) Data Intelligence (DI) team is a strategic thought partner to key stakeholders and an integral contributor to the company's clinical operational planning efforts. The role contributes to an integrated Clinical Operations Plan (iCOP) which is used to guide end-to-end, cross-business unit, Clinical Operations planning and strategies at the disease area (DA) level. The role provides strategic operational insights with their capabilities in the following areas: forecasting, landscape analysis, advanced data analysis, and project management, to support Clinical Operations and management for effective data-driven decision making. This role participates and leads in global workgroups and initiatives to define cross-business unit best practice for processing, analyzing, generating actionable insights, and presenting data in innovative and consumable ways to address inquiries, as well as to support business planning and strategies. The Opportunity: ● Work with cross-business unit Clinical Operations DA level workgroups (e.g., iCOP team), Clinical Operations leaders, project/study teams, lifecycle teams to understand business needs and priorities, as well as immediate scope of work. ● Deliver integrated insights and analytics, trade-off analyses, and risk assessment to enable optimization of patient recruitment strategies, country footprint, and clinical site selection at DA level in addition to for study teams and ECD Clinical Operations management. ● Proactively partner with relevant stakeholders to assess the health of the portfolio and identify opportunities to expedite evidence generation and to accelerate the delivery of studies and product launches. ● Utilizes state-of-art methodologies (including predictive modeling, ML/AI and scalable prototypes) and tools to analyze complex data (Real World Data and internal data) and interpret analysis of results to measure project/study performance and guide portfolio-level decisions efficiently. ● Take the initiative in identifying, interpreting, and communicating the effects that trial design elements, country and site selection, competitor activities and new engagement tactics will have on clinical trial recruitment and retention forecasts. ● Lead relevant data science and analytics projects, manage the implementation of the product development cycle, and ensure the success of the product. ● Actively lead/participate in related cross-functional communities and collaborate with subject matter experts (SMEs) from cross-business units in global workstreams. Through analytics expertise and deep technical knowledge, contribute to the creation and implementation of globally aligned strategies and tools. ● Identify potential opportunities for continuous improvement; engage managers and peer groups regularly for coaching, assistance, and advocacy. ● Lead and coach junior team members. ● Consult with IT service and data governance teams to clarify data needs. Lead internal and/or external team members to acquire, aggregate and curate data and information. Who You Are: ● Bachelor's degree in Data Science, Mathematics, Statistics, Computer Science, Life Sciences, Public Health, or a related field; Graduate-level degree preferred. ● 7+ years of experience with Bachelors; 5+ years of work experience with Masters; 3+ years of work experience with PhD, in the following areas: Patient Insights, Investigator Insights, Forecasting, Competitive Intelligence, Advanced Data Analytics, Information Visualization, and Data Science in Clinical Operations in the pharmaceutical/biotech industry. ● Strong proven experience working with and engaging Clinical Operations stakeholders, and acting as a strategic thought partner to teams. ● Experience of leading/working with SMEs from cross-business units to understand and diagnose business problems, as well as using data driven methods to analyze and solve business situations. ● Experience with scripting and analytical programming preferred (e.g., Python, R, SQL, JavaScript, or other JavaScript-based libraries) ● Knowledge of snowflake/cloud, architecture, and data modeling concepts preferred. Experience with various forecasting methods and techniques strongly preferred. ● Record of portfolio management experience and effectively leading/working in a matrix environment with team members using influence without authority. Able to multi-task and re-prioritize work on short notice, able to lean in and manage through change. ● Persuasive written and verbal communication skills, easily communicating complex ideas. Strong interpersonal skills and a consultative mindset, with the ability to develop strong partnerships. Relocation benefits are not available for this posting. Onsite presence, on our South San Francisco campus, is expected for at least 3 days a week. The expected salary range for this position based on the primary location of South San Francisco, California is $148,100 - $275,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #LI-JD1 #ECD Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $148.1k-275k yearly Auto-Apply 11d ago
  • TEMP - Associate Scientist, Biologics Research

    Neurocrine Biosciences 4.7company rating

    San Diego, CA job

    Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role:Assists with setting up and execution of experiments and support the validation of AAV gene therapies. May set up biochemical & cell-based assays to support production, identification, optimization, and characterization of AAV gene therapies. May analyze and present data to lead scientists in an organized and timely manner. Work within and support biology needs of discovery teams. Performs research and/or development in collaboration with others for projects. Makes detailed observations, analyzes data and interprets results with some supervision. Investigates, creates and develops new methods and technologies for project advancement. Obtains professional expertise through familiarity with scientific literature and educational tools. May participate in scientific conferences and contribute to scientific journals. _ Your Contributions (include, but are not limited to): Performs experiments with some supervision in support of scientific activities and project goals involving cell and biochemical assays Follows new methods and techniques and seeks out senior personnel for training and to discuss clarifications and explanations of methods and results Generates complex bioinformatic data sets following SOPs, and assists in data analysis Assists in maintenance of cell culture facilities, including growing cell cultures, cell banking and cleaning and stocking of equipment and rooms. Follows SOP's and organizes data for experiments conducted, and presents data to research team members Complies with all SOP's, and safety and quality assurance standards at all times May assist in research and support of Gene Therapy drug development Other duties as assigned Requirements: BS/BA degree and some relevant experience preferred General knowledge of AAV biology and/or protein engineering Experience with molecular biology techniques such as PCR, digital PCR, gel electrophoresis, western blot/ELISA, plasmid design, cloning, and sequencing Experience with cell culture in vitro techniques such as cell passage of adherent and suspension cells, sterile technique, media preparation, cell lysis, and material processing Excellent critical analysis skills and ability to assess data and research findings outside of Neurocrine for application to new scientific projects Advanced knowledge and demonstrated ability to work with a variety of laboratory equipment/tools Ability to work as part of teams Excellent computer skills Excellent communication skills Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency LI-OB1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.
    $70k-102k yearly est. Auto-Apply 60d+ ago
  • Clinical Site Contracts Administrator

    Neurocrine Biosciences 4.7company rating

    San Diego, CA job

    Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis* and uterine fibroids,* as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. ( *in collaboration with AbbVie ) About the Role: Provide support in the site contract lifecycle management. Responsible for supporting the development of clinical site budgets including review, adjustment, and negotiation with clinical sites. Support the clinical study teams in the timely study startup and with legal department to help ensure clinical site contracts are fully executed in a timely manner. Support the administration, negotiation and execution of clinical site contracts towards the goal of favorable terms regarding study budget, timelines and deliverables including site payments, across multiple projects. _ Your Contributions: Support a timely and successful negotiation and on-going administration of clinical site contracts including CDAs, CTAs, CTA Amendments, and other site-contract related agreements in accordance with study timelines. Collaborate with clinical research sites for inhouse run studies, assist with site-specific challenges, and assist with study-related documentation. Learn to build site budgets including negotiations, triage, review, and identifying issues for escalation. Support in finding solutions for potential roadblocks and challenges in the study start-up process, including site budget constraints and contract discrepancies. Effectively communicate site budget issues and facilitate problem resolution. Present CDA and CTA updates in team meetings. Utilize strong analytical skills to assess issues and propose solutions. Check clinical site contracts for completeness and accuracy and ensure adherence to department guidelines; corrects documents as necessary. Facilitate the contract signing process as directed. Track all site interaction in a timely and accurate manner and ensure the status updates are fully descriptive. Track and create files for all site related contracts. Facilitate the CTA start-up process and develop the CTA and payment terms template, site budget, and supporting documentation to sites and serve as the site contract and budget point person with sites or CRO. Submit web requests and coordinate with Legal Department on execution of CTAs. Negotiate site budget with clinical sites based on parameters defined by Head of Clinical Operations (or designee). Co-manage site payments for inhouse run studies and accounting related activities to ensure payments are made in a timely manner and based on executed site contract. Collaborate with finance/accounting departments in support of site contract budgets. Contribute to the development and organization of site contracting and budget/payment processes. Other duties as assigned. Requirements: Bachelor's degree in relevant field and 2+ years of contracts administration or similar transactional experience in a role that requires direct interaction with clinical sites and internal stakeholders Understands Neurocrine's business objectives and develop understanding of Neurocrine's services and customers Experience in specific functional discipline while working to acquire higher-level knowledge and skills Comfortable working with tools and processes that support work conducted by functional area Ability to work as part of a team Strong computer skills Strong communications, problem-solving, analytical thinking skills Must be detail oriented Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Knowledge of Clinical Trial process, regulations and guidelines Ability to read and interpret contracts, ensure contract language / terms meet company standards Good contract administration skills, including budgeting, billing/invoicing, issue resolution, point of contact for CRO and or/study teams Knowledge of clinical contract accounting and budgeting process Excellent interpersonal and communication skills and experience supporting multiple teams #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The hourly rate we reasonably expect to pay is $39.61-$57.45. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
    $39.6-57.5 hourly Auto-Apply 60d+ ago
  • Packaging Engineer/Sr. Packaging Engineer

    Genentech 4.5company rating

    South San Francisco, CA job

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche. Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide. This position supports the establishment of a world class Global Packaging Development organization by applying technical leadership and expertise in the development, qualification, and deployment of new packaging systems for small molecule, parenteral, gene therapy and combination products. The success of this position requires effective collaborations and trusted relationships with Pharmaceutical Development, External Manufacturing, Marketing, Supply Chain, Packaging Operations, Regulatory, etc. The Opportunity General responsibilities: Lead packaging engineering projects within global teams in order to meet predefined timelines, quality, and budget. Deliver innovative, best in class packaging solutions to meet patient and business needs. Develop and qualify global packaging solutions for products through the packaging lifecycle, understanding customer needs and leveraging the organization. Innovate: Evaluate and screen new technologies, and new materials and/or packaging solutions based on patient, product, regulatory, business or technical requirements. Ensure compliance with international procedures and external regulations. Actively support a culture of knowledge sharing and interaction across packaging and device development teams. Who you are For this position, you bring the following qualifications: Bachelor degree in materials science, packaging engineering, mechanical engineering or related field; with a minimum of 2+ years with Bachelors (or 0+ yrs w/ Masters) for packaging engineer, OR a minimum of 5+ years with Bachelors (or 3+ yrs w/ Masters) for sr. packaging engineer working in packaging development lifecycle activities in the Pharma, Medical Device, Food or Cosmetic industry. Technical expertise in packaging design, test methods and packaging equipment and process qualification / validation. Sound knowledge of legislation, regulatory guidance and industry standards for packaging (e.g. ISTA/ASTM, design and validation / qualification, ISO, USP/EU/JP Compendia, ICH, and 21 CFR Part4). Excellent documentation practices: user requirements, design control, specifications, qualification protocols/reports for packaging systems, risk assessments, and shipping qualification activities. Innovative spirit leading to industry best practices. Design thinking, design management, drives creativity. Preferred: Project management skills and experience in cross-functional projects. Fosters team effectiveness, team spirit, team alignment, shares risks within the team beyond the function. Traveling is required approximately 10-20%. This position is an on-site position and located at the US Headquarters of Genentech in South San Francisco, CA. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of South San Francisco, CA is $92,600 to $172,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits #LI-PK1 Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
    $92.6k-172k yearly Auto-Apply 16d ago

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