As an Associate Software Engineer, your role involves designing, developing, deploying, and maintaining software applications and solutions to meet business needs. This includes working on complex systems, optimizing storage solutions, and integrating third-party services to build robust Generative AI (GenAI) platforms for Chemistry, Manufacturing, and Controls (CMC). You will be part of a regulatory submission content automation initiative, focusing on digitizing and modernizing regulatory submissions using advanced technologies like GenAI, structured content management, and data integration. Key Responsibilities: - Write clean, efficient, and maintainable code for GenAI content authoring/management systems - Build APIs and services to handle GenAI content retrieval, storage, and rendering - Develop front-end (React) and back-end (Python) components for CMC content solutions - Deploy and manage content solution infrastructure using Infrastructure-as-Code (e.g., AWS RDS, DynamoDB, S3, Lambda, ECS) - Support system maintenance, upgrades, and bug fixes - Participate in technical discussions and code/design reviews to influence architecture - Create and maintain technical documentation - Stay current with the latest trends in content management and authoring technologies - Collaborate with product, business, and cross-functional teams Qualifications Required: - Bachelor's degree in Computer Science, IT, or related field with 3 years of experience OR Diploma with 4-7 years of relevant experience Functional Skills: Must-Have: - Solid understanding of software development processes, databases, and connected systems requiring ontologies and data dictionaries - Proficiency in Java, Python, or JavaScript - Experience with API development and ontology mapping - Hands-on experience with SQL/NoSQL databases - Familiarity with Jira and collaboration tools Good-to-Have: - Experience in building/supporting GenAI solutions - Familiarity with cloud infrastructure and Infrastructure-as-Code - Exposure to CI/CD pipelines, version control, and Agile development - Understanding of pharmaceutical regulatory submission processes (e.g., eCTD, ICH, CDS, USPI) Soft Skills: - Excellent analytical and troubleshooting abilities - Strong verbal and written communication skills - Comfortable working with global, virtual teams - High level of initiative and self-motivation - Ability to manage multiple priorities effectively - Team-oriented mindset with strong collaboration skills - Confident in presentations and public speaking As an Associate Software Engineer, your role involves designing, developing, deploying, and maintaining software applications and solutions to meet business needs. This includes working on complex systems, optimizing storage solutions, and integrating third-party services to build robust Generative AI (GenAI) platforms for Chemistry, Manufacturing, and Controls (CMC). You will be part of a regulatory submission content automation initiative, focusing on digitizing and modernizing regulatory submissions using advanced technologies like GenAI, structured content management, and data integration. Key Responsibilities: - Write clean, efficient, and maintainable code for GenAI content authoring/management systems - Build APIs and services to handle GenAI content retrieval, storage, and rendering - Develop front-end (React) and back-end (Python) components for CMC content solutions - Deploy and manage content solution infrastructure using Infrastructure-as-Code (e.g., AWS RDS, DynamoDB, S3, Lambda, ECS) - Support system maintenance, upgrades, and bug fixes - Participate in technical discussions and code/design reviews to influence architecture - Create and maintain technical documentation - Stay current with the latest trends in content management and authoring technologies - Collaborate with product, business, and cross-functional teams Qualifications Required: - Bachelor's degree in Computer Science, IT, or related field with 3 years of experience OR Diploma with 4-7 years of relevant experience Functional Skills: Must-Have: - Solid understanding of software development processes, databases, and connected systems requiring ontologies and data dictionaries - Proficiency in Java, Python, or JavaScript - Experience with API development and ontology mapping - Hands-on experience with SQL/NoSQL databases - Familiarity with Jira and collaboration tools Good-to-Have: - Experience in building/supporting GenAI solutions - Familiarity with cloud infrastructure and Infrastructure-as-Code - Exposure to CI/CD pipelines, version control, and Agile development - Understanding of pharmaceutical regulatory submission processes (e.g., eCTD, ICH, CDS, USPI) Soft Skills: - Excellent analytical and troubleshooting abilities - Strong verbal and written communication skills - Comfortable working with global, virtual teams - High level of initiative and self-motivation - Ability to manage multiple priorities effectively - Team-orien
In this vital role, as a Vulnerability Management Analyst, you will be focused on identifying, assessing, prioritizing, and tracking the remediation of vulnerabilities across the organization's technology stack. Your key responsibility will be to play a crucial role in the security operations team by ensuring known vulnerabilities are managed through their lifecycle using structured processes and tools. You will analyze vulnerability scan data, correlate threat intelligence (e.g., KEV, EPSS), and work closely with infrastructure, application, and business teams to drive risk-based remediation. **Roles & Responsibilities** - Analyze vulnerability scan results from tools like Tenable, Qualys, or Rapid7 to identify security weaknesses across infrastructure and applications. - Prioritize vulnerabilities using multiple criteria, including CVSS, KEV (Known Exploited Vulnerabilities), EPSS (Exploit Prediction Scoring System), asset criticality, and business context. - Partner with IT and DevOps teams to track remediation progress and provide technical guidance on mitigation strategies. - Monitor threat intelligence feeds to correlate vulnerabilities with current exploit activity. - Create and maintain vulnerability metrics, dashboards, and reports for leadership and compliance teams. - Support vulnerability assessment activities in cloud environments (AWS, Azure, etc.). - Maintain documentation related to the vulnerability management lifecycle. - Assist in policy and process development related to vulnerability and patch management. - Participate in audits and compliance efforts (e.g., SOX, ISO, NIST, PCI). **Qualifications Required** - Master's degree and 1 to 3 years of experience in Cybersecurity, vulnerability management, or information security operations; OR - Bachelor's degree and 3 to 5 years of experience in Cybersecurity, vulnerability management, or information security operations; OR - Diploma and 7 to 9 years of experience in Cybersecurity, vulnerability management, or information security operations. **Must-Have Skills** - Familiarity with vulnerability management tools (e.g., Tenable, Qualys, Rapid7). - Understanding of CVSS scoring, vulnerability lifecycle, and remediation workflows. - Basic knowledge of threat intelligence and how it applies to vulnerability prioritization. - Working knowledge of network, operating system, and application-level security. - Ability to analyze scan data and correlate it with business context and threat intelligence. **Preferred Qualifications** - Experience with KEV, EPSS, and other threat-based scoring systems. - Familiarity with patch management processes and tools. - Exposure to cloud security and related scanning tools (e.g., Prisma Cloud, AWS Inspector). - Certifications (one or more preferred):CompTIA Security+, GIAC GSEC / GCIH, Qualys Vulnerability Management Specialist (QVMS), Tenable Certified Nessus Auditor (TCNA). **Soft Skills** - Analytical Thinking: Ability to interpret complex data sets and assess risk effectively. - Attention to Detail: Precision in identifying and tracking vulnerabilities and remediation status. - Communication Skills: Ability to communicate technical findings to both technical and non-technical audiences. - Collaboration & Teamwork: Able to work across IT, DevOps, and security teams to drive resolution. - Curiosity & Continuous Learning: Willingness to stay current with evolving threats and technologies. - Problem-Solving Approach: Capability to identify solutions to security weaknesses in diverse environments. In this vital role, as a Vulnerability Management Analyst, you will be focused on identifying, assessing, prioritizing, and tracking the remediation of vulnerabilities across the organization's technology stack. Your key responsibility will be to play a crucial role in the security operations team by ensuring known vulnerabilities are managed through their lifecycle using structured processes and tools. You will analyze vulnerability scan data, correlate threat intelligence (e.g., KEV, EPSS), and work closely with infrastructure, application, and business teams to drive risk-based remediation. **Roles & Responsibilities** - Analyze vulnerability scan results from tools like Tenable, Qualys, or Rapid7 to identify security weaknesses across infrastructure and applications. - Prioritize vulnerabilities using multiple criteria, including CVSS, KEV (Known Exploited Vulnerabilities), EPSS (Exploit Prediction Scoring System), asset criticality, and business context. - Partner with IT and DevOps teams to track remediation progress and provide technical guidance on mitigation strategies. - Monitor threat intelligence feeds to correlate vulnerabilities with current exploit activity. - Create and maintain vulnerability metrics, dashboards, and reports for leadership and compliance teams. - Support vulnerability assessment activities in cloud environments (AWS, Azure, etc.). - Maintain documentation related to the vulnerability m
As a Software Engineer, you will collaborate with business partners and other team members to develop and deploy advanced technologies to optimize products. You will work closely with delivery and platform teams to align applications with architectural and development guidelines. Additionally, you will support the design and development of Proof-of-Concept automated solutions, quickly iterating on concepts. Your responsibilities will include developing systems architecture, integrating hardware and software components, conducting system testing, and optimizing system performance. You will also be responsible for creating and maintaining documentation, working with other engineers and project managers, and implementing network solutions for connectivity, performance, and security. Key Responsibilities: - Collaborate with business partners and software engineers to deploy advanced technologies - Ensure alignment of applications with architectural and development guidelines - Design and develop Proof-of-Concept automated solutions - Develop systems architecture to meet current and future organizational needs - Integrate hardware and software components into cohesive systems - Conduct system testing and validation - Optimize system performance and troubleshoot issues - Create and maintain comprehensive systems documentation - Implement network solutions for connectivity, performance, and security Qualifications Required: - Bachelor's degree with 6 - 8 years of experience in Computer Science, IT, or related field OR Diploma with 10-12 years of experience in Computer Science, IT, or related field - Knowledge of network security protocols and tools - Experience with cloud platforms like AWS, Azure, or Google Cloud - Ability to translate business requirements to technical solutions for automation In addition to the technical qualifications, the following soft skills are desirable: - Excellent analytical and troubleshooting skills - Strong verbal and written communication skills - Ability to work effectively in global, virtual teams - High degree of initiative and self-motivation - Strong presentation and public speaking skills Experience with cloud security, DevOps tools, networking protocols, systems engineering processes, and systems integration and validation would be considered advantageous for this role. As a Software Engineer, you will collaborate with business partners and other team members to develop and deploy advanced technologies to optimize products. You will work closely with delivery and platform teams to align applications with architectural and development guidelines. Additionally, you will support the design and development of Proof-of-Concept automated solutions, quickly iterating on concepts. Your responsibilities will include developing systems architecture, integrating hardware and software components, conducting system testing, and optimizing system performance. You will also be responsible for creating and maintaining documentation, working with other engineers and project managers, and implementing network solutions for connectivity, performance, and security. Key Responsibilities: - Collaborate with business partners and software engineers to deploy advanced technologies - Ensure alignment of applications with architectural and development guidelines - Design and develop Proof-of-Concept automated solutions - Develop systems architecture to meet current and future organizational needs - Integrate hardware and software components into cohesive systems - Conduct system testing and validation - Optimize system performance and troubleshoot issues - Create and maintain comprehensive systems documentation - Implement network solutions for connectivity, performance, and security Qualifications Required: - Bachelor's degree with 6 - 8 years of experience in Computer Science, IT, or related field OR Diploma with 10-12 years of experience in Computer Science, IT, or related field - Knowledge of network security protocols and tools - Experience with cloud platforms like AWS, Azure, or Google Cloud - Ability to translate business requirements to technical solutions for automation In addition to the technical qualifications, the following soft skills are desirable: - Excellent analytical and troubleshooting skills - Strong verbal and written communication skills - Ability to work effectively in global, virtual teams - High degree of initiative and self-motivation - Strong presentation and public speaking skills Experience with cloud security, DevOps tools, networking protocols, systems engineering processes, and systems integration and validation would be considered advantageous for this role.
As a Project Manager, you will be responsible for overseeing a portfolio of projects and/or programs to ensure alignment with the organization's strategic objectives and delivery of maximum value and outcomes. You will work closely across teams to lead and deliver program and project management services through all phases of the Project Management Lifecycle (PMLC). **Key Responsibilities:** - Define project/program scope, goals, and deliverables in collaboration with senior management and stakeholders - Lead the project team in executing the project plan, monitoring progress, and making necessary adjustments - Deliver successfully against project schedule, scope, and financial commitments - Maintain budgetary responsibility of the project(s) - Identify potential risks, develop mitigation strategies, and ensure project deliverables meet quality standards - Coordinate resources across projects, manage dependencies, and resolve conflicts - Track ongoing program performance using appropriate tools and techniques **Qualifications Required:** - Doctorate Degree OR Masters degree with 4 - 6 years of experience in Computer Science, IT, or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, IT, or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, or related field In addition to the above, you should have the following **Must-Have Skills**: - Proven track record of delivering high impact projects - Extensive knowledge of program and project management methodologies - Strong knowledge of change management principles - Experience with Agile delivery and project analysis tools - Cost & Budget management experience - Experience with technology enabling projects **Good-to-Have Skills** include: - Proficiency with program management software and tools - Experience with organizational change initiatives and transformations - Experience with GxP projects in life sciences space **Professional Certifications:** - Project Management Professional (PMP) or equivalent certification (preferred) - Certified Change Management Professional (CCMP) or equivalent (preferred) **Soft Skills:** - Excellent analytical and troubleshooting skills - Strong leadership and strategic thinking abilities - Effective verbal and written communication skills - Ability to work effectively with global, virtual teams - High degree of initiative and self-motivation - Strong presentation and public speaking skills - Ability to deal with ambiguity and influence outcomes Lastly, you will be required to work during evening or night shifts based on business requirements. As a Project Manager, you will be responsible for overseeing a portfolio of projects and/or programs to ensure alignment with the organization's strategic objectives and delivery of maximum value and outcomes. You will work closely across teams to lead and deliver program and project management services through all phases of the Project Management Lifecycle (PMLC). **Key Responsibilities:** - Define project/program scope, goals, and deliverables in collaboration with senior management and stakeholders - Lead the project team in executing the project plan, monitoring progress, and making necessary adjustments - Deliver successfully against project schedule, scope, and financial commitments - Maintain budgetary responsibility of the project(s) - Identify potential risks, develop mitigation strategies, and ensure project deliverables meet quality standards - Coordinate resources across projects, manage dependencies, and resolve conflicts - Track ongoing program performance using appropriate tools and techniques **Qualifications Required:** - Doctorate Degree OR Masters degree with 4 - 6 years of experience in Computer Science, IT, or related field OR Bachelors degree with 6 - 8 years of experience in Computer Science, IT, or related field OR Diploma with 10 - 12 years of experience in Computer Science, IT, or related field In addition to the above, you should have the following **Must-Have Skills**: - Proven track record of delivering high impact projects - Extensive knowledge of program and project management methodologies - Strong knowledge of change management principles - Experience with Agile delivery and project analysis tools - Cost & Budget management experience - Experience with technology enabling projects **Good-to-Have Skills** include: - Proficiency with program management software and tools - Experience with organizational change initiatives and transformations - Experience with GxP projects in life sciences space **Professional Certifications:** - Project Management Professional (PMP) or equivalent certification (preferred) - Certified Change Management Professional (CCMP) or equivalent (preferred) **Soft Skills:** - Excellent analytical and troubleshooting skills - Strong leadership and strategic thinking abilities - Effective verbal and written communication skills - Ability to work effectively with gl
As a highly skilled and experienced Principal AI Solution Architect, you will lead the design and development of enterprise-level AI solutions. Your role will involve providing thought leadership and driving AI and GenAI solutions, particularly in collaboration with the Master Data Management (MDM) Center of Excellence (CoE). Your extensive hands-on experience in AI/ML, data science, and GenAI technologies, along with knowledge of MDM, will be essential to ensure the scalability, reliability, and performance of the solutions. **Key Responsibilities:** - **AI Architecture & Solutioning:** Lead the design and development of enterprise-level GenAI applications using frameworks like Langchain, Autogen, and Hugging Face. Architect intelligent data pipelines using PySpark, TensorFlow, and PyTorch within Databricks and AWS environments. - **Data Integration & Engineering:** Integrate and leverage MDM platforms like Informatica and Reltio to supply high-quality structured data to ML systems. Utilize SQL and Python for data engineering, data wrangling, and pipeline automation. - **GenAI Implementation:** Implement embedding models and manage VectorStores for Retrieval-Augmented Generation (RAG) solutions. Build scalable APIs and services to serve GenAI models in production. - **Leadership & Collaboration:** Lead cross-functional collaboration with data scientists, engineers, and product teams to scope, design, and deploy AI-powered systems. Provide thought leadership and mentorship to junior team members. - **Governance & Compliance:** Ensure model governance, version control, and auditability are aligned with regulatory and compliance expectations. **Technical Skills:** - Extensive hands-on experience (14+ years) in AI/ML or Data Science, including designing and implementing GenAI solutions. - Expertise in AI/ML solution architecture and design, with a strong knowledge of industry best practices. - Hands-on experience with Python, PySpark, PyTorch, LLMs, Vector DB, Embeddings, Langchain, Autogen, and frameworks like TensorFlow. - Experience designing GenAI-based solutions using the Databricks platform. - Strong knowledge of AWS and cloud-based AI infrastructure. - Prior experience in Data Modeling, ETL development, and data profiling to support AI/ML workflows is a plus. - Proficiency in tools like JIRA and Confluence for Agile delivery is a plus. - AWS or Azure certifications, and Data Science and ML certifications are preferred. **Qualifications:** - A Master's degree with 11-14 years of experience, a Bachelor's degree with 15-16 years of experience, or a Diploma with 17-18 years of hands-on experience in Data Science, AI/ML technologies, or related technical domains. As a Principal AI Solution Architect, you are expected to possess strong soft skills such as leadership, problem-solving, collaboration, and communication to effectively manage and mentor junior team members, solve complex problems, collaborate with cross-functional teams, and convey technical concepts to stakeholders. As a highly skilled and experienced Principal AI Solution Architect, you will lead the design and development of enterprise-level AI solutions. Your role will involve providing thought leadership and driving AI and GenAI solutions, particularly in collaboration with the Master Data Management (MDM) Center of Excellence (CoE). Your extensive hands-on experience in AI/ML, data science, and GenAI technologies, along with knowledge of MDM, will be essential to ensure the scalability, reliability, and performance of the solutions. **Key Responsibilities:** - **AI Architecture & Solutioning:** Lead the design and development of enterprise-level GenAI applications using frameworks like Langchain, Autogen, and Hugging Face. Architect intelligent data pipelines using PySpark, TensorFlow, and PyTorch within Databricks and AWS environments. - **Data Integration & Engineering:** Integrate and leverage MDM platforms like Informatica and Reltio to supply high-quality structured data to ML systems. Utilize SQL and Python for data engineering, data wrangling, and pipeline automation. - **GenAI Implementation:** Implement embedding models and manage VectorStores for Retrieval-Augmented Generation (RAG) solutions. Build scalable APIs and services to serve GenAI models in production. - **Leadership & Collaboration:** Lead cross-functional collaboration with data scientists, engineers, and product teams to scope, design, and deploy AI-powered systems. Provide thought leadership and mentorship to junior team members. - **Governance & Compliance:** Ensure model governance, version control, and auditability are aligned with regulatory and compliance expectations. **Technical Skills:** - Extensive hands-on experience (14+ years) in AI/ML or Data Science, including designing and implementing GenAI solutions. - Expertise in AI/ML solution architecture and design, with a strong knowledge of industry best practices. - Hands-on experience with Python, PySpa
You will play a crucial role as a Senior Associate Visualization Engineer within Amgen's Global Medical Data and Analytics team. Your primary responsibility will be to lead the technology ecosystem for enhancing Amgen's analytics and visualization capability, focusing on delivering analytics tools and capabilities across the Global Medical business organization. Here are the key responsibilities associated with this role: - Be accountable for the development and deployment of advanced data visualization solutions for Global Medical teams, enabling actionable insights. - Support lifecycle management and ownership of technology assets. - Develop interactive dashboards and analytical reports using tools like Tableau and Power BI to visualize complex medical data for stakeholders. - Create visualization prototypes for interactive applications using frameworks like React js. - Drive innovation in data visualization by introducing advanced techniques like predictive analytics and dynamic storytelling. - Monitor and enhance the performance of visualization tools to ensure optimal load times and usability. - Partner with leadership to define and implement technology solutions aligned with the organization's objectives. - Implement automated data validation frameworks to ensure consistency and reduce errors. - Translate business requirements into scalable visualization solutions. - Present data insights and visualization solutions to senior leadership for data-driven decision-making. - Establish and monitor KPIs for the visualization team to ensure alignment with business goals. - Drive cross-functional collaboration to streamline workflows and enhance efficiency. - Implement reusable, scalable frameworks for visualization solutions to support global reporting needs. - Support ad-hoc and strategic reporting requests with customized data visualizations. In terms of technical expertise and innovation, you are expected to: - Stay updated with emerging trends and tools in data visualization and analytics. - Advocate for the adoption of cutting-edge tools and methodologies. - Collaborate on the development of a centralized data lake and ensure alignment with enterprise architecture standards. - Commit to learning and staying at the forefront of AI/ML advancements. Key skills required for this role include expertise in visualization tools such as Tableau, Power BI, or React js equivalent, proficiency in SQL, Python, R, or other data analysis programming languages, strong understanding of medical data models, excellent communication and stakeholder management skills, and strong project management skills. The basic qualifications for this position include a Doctorate degree, Masters degree with 2-6 years of Information Systems experience, or a Bachelors degree with relevant experience. Preferred qualifications include a degree in Data Science, Computer Science, Analytics, Business Administration, or a related field, along with experience in data analytics, visualization, or business intelligence. Moreover, you are expected to have excellent communication and interpersonal skills, the ability to work collaboratively with cross-functional teams, strong analytical and problem-solving skills, and the ability to analyze and model large datasets. It is also beneficial to have work experience in the biotechnology or pharmaceutical industry, experience using Scaled Agile Framework (SAFe), the ability to work effectively in a fast-paced environment, and a commitment to ongoing learning and staying updated with AI/ML advancements. Professional certifications such as SAFe for Teams certification and Tableau certification are considered advantageous for this role. You will play a crucial role as a Senior Associate Visualization Engineer within Amgen's Global Medical Data and Analytics team. Your primary responsibility will be to lead the technology ecosystem for enhancing Amgen's analytics and visualization capability, focusing on delivering analytics tools and capabilities across the Global Medical business organization. Here are the key responsibilities associated with this role: - Be accountable for the development and deployment of advanced data visualization solutions for Global Medical teams, enabling actionable insights. - Support lifecycle management and ownership of technology assets. - Develop interactive dashboards and analytical reports using tools like Tableau and Power BI to visualize complex medical data for stakeholders. - Create visualization prototypes for interactive applications using frameworks like React js. - Drive innovation in data visualization by introducing advanced techniques like predictive analytics and dynamic storytelling. - Monitor and enhance the performance of visualization tools to ensure optimal load times and usability. - Partner with leadership to define and implement technology solutions aligned with the organization's objectives. - Implement automated data validation frameworks to ensur
As a Sr Associate- Project Coordinator, you will be responsible for project management and coordination of material management and shipping activities for assigned studies including PK and Immunogenicity testing. Your role involves tracking supplier timelines, deliverables, and study milestones while identifying risks and issues early. You will also document issues, actions, and decisions in accordance with established processes. Your key responsibilities will include: - Serving as the primary point of contact for assigned suppliers - Communicating updates to suppliers, BAPS, and R&S regarding timelines, issues, and study status - Coordinating responses to requests for additional testing or information - Drafting and maintaining study documentation, trackers, and reports - Reviewing and submitting study reports for internal review - Supporting budget tracking and loss reporting activities - Ensuring coordination activities comply with GCP, GLP, and CLIA requirements - Supporting audit readiness through accurate documentation and timely issue resolution - Utilizing SharePoint, spreadsheets, and presentation tools to manage trackers, reports, and communications Qualifications required for this position include a Bachelors degree with 2 years of related experience, excellent written and verbal communication skills, experience using electronic document management systems, outstanding attention to detail, proficiency in Microsoft Office and online collaboration tools, strong team player skills, sharp learning agility, problem-solving abilities, and experience in biotechnology or other healthcare environments. Additionally, preferred qualifications include specialized knowledge within the informed consent field, biobank operations, and a basic knowledge of laboratory information management systems. You should also have experience in drafting and interpreting clinical protocol and ICF language, knowledge of related regulatory/industry considerations and compliance issues. This role is at a Senior Level, and you will be expected to apply principles, concepts, theories, and standards of the professional field, demonstrating competencies in various areas related to project coordination and management. As a Sr Associate- Project Coordinator, you will be responsible for project management and coordination of material management and shipping activities for assigned studies including PK and Immunogenicity testing. Your role involves tracking supplier timelines, deliverables, and study milestones while identifying risks and issues early. You will also document issues, actions, and decisions in accordance with established processes. Your key responsibilities will include: - Serving as the primary point of contact for assigned suppliers - Communicating updates to suppliers, BAPS, and R&S regarding timelines, issues, and study status - Coordinating responses to requests for additional testing or information - Drafting and maintaining study documentation, trackers, and reports - Reviewing and submitting study reports for internal review - Supporting budget tracking and loss reporting activities - Ensuring coordination activities comply with GCP, GLP, and CLIA requirements - Supporting audit readiness through accurate documentation and timely issue resolution - Utilizing SharePoint, spreadsheets, and presentation tools to manage trackers, reports, and communications Qualifications required for this position include a Bachelors degree with 2 years of related experience, excellent written and verbal communication skills, experience using electronic document management systems, outstanding attention to detail, proficiency in Microsoft Office and online collaboration tools, strong team player skills, sharp learning agility, problem-solving abilities, and experience in biotechnology or other healthcare environments. Additionally, preferred qualifications include specialized knowledge within the informed consent field, biobank operations, and a basic knowledge of laboratory information management systems. You should also have experience in drafting and interpreting clinical protocol and ICF language, knowledge of related regulatory/industry considerations and compliance issues. This role is at a Senior Level, and you will be expected to apply principles, concepts, theories, and standards of the professional field, demonstrating competencies in various areas related to project coordination and management.
As an Engineering Projects Senior Manager at Amgen, you will be responsible for managing projects for facilities, equipment, and system changes at Amgens Hyderabad Genome Valley Facilities. Your role will involve applying project management principles to lead cross-functional teams, develop project scopes, obtain funding approval, and implement new or modified facilities, process equipment, and infrastructure. Additionally, you will lead cross-functional project teams to implement facilities and equipment upgrades, changes, and installations while providing technical expertise to manage troubleshooting and resolve equipment and facility issues in the field. **Responsibilities:** - Manage the design and/or construction for various size engineering projects, developing project proposals, cost estimates, and execution plans. - Ensure capital and expense projects comply with global Amgen and site standards to achieve project objectives safely, on time, on budget, and meeting quality requirements. - Lead projects in active operations, renovating existing facilities and equipment, including contractor supervision and commissioning/validation of systems. - Develop project schedules, budgets, cash flows, business justifications, and project design documentation. - Communicate effectively across multi-functional teams, review progress, schedule, and costs, and provide regular updates to clients and management. - Supervise, coordinate, and review the work of team members or third-party resources. - Motivate the project team towards successful outcomes, working both independently and collaboratively. - Be willing to relocate onsite at Amgens Hyderabad Genome Valley facility and support projects in India and other JAPAC countries. **Basic Qualifications:** - Doctorate degree in engineering or related technical field and 6 years of directly related experience OR - Masters degree in engineering or related technical field and 10 years of directly related experience OR - Bachelors degree in engineering or related technical field and/or 15 years of directly related experience **Preferred Qualifications:** - 5 or more years experience in project management for lab or manufacturing environments. - Broad knowledge and experience in design, planning, construction, and startup of projects, preferably in GMP manufacturing and utility systems. - Demonstrated skills in design, engineering, troubleshooting, and cross-functional team leadership. - Proficient presentation and facilitation skills. Please note that all listed tasks and responsibilities are essential functions of this position. However, additional tasks and responsibilities may be required based on business conditions. As an Engineering Projects Senior Manager at Amgen, you will be responsible for managing projects for facilities, equipment, and system changes at Amgens Hyderabad Genome Valley Facilities. Your role will involve applying project management principles to lead cross-functional teams, develop project scopes, obtain funding approval, and implement new or modified facilities, process equipment, and infrastructure. Additionally, you will lead cross-functional project teams to implement facilities and equipment upgrades, changes, and installations while providing technical expertise to manage troubleshooting and resolve equipment and facility issues in the field. **Responsibilities:** - Manage the design and/or construction for various size engineering projects, developing project proposals, cost estimates, and execution plans. - Ensure capital and expense projects comply with global Amgen and site standards to achieve project objectives safely, on time, on budget, and meeting quality requirements. - Lead projects in active operations, renovating existing facilities and equipment, including contractor supervision and commissioning/validation of systems. - Develop project schedules, budgets, cash flows, business justifications, and project design documentation. - Communicate effectively across multi-functional teams, review progress, schedule, and costs, and provide regular updates to clients and management. - Supervise, coordinate, and review the work of team members or third-party resources. - Motivate the project team towards successful outcomes, working both independently and collaboratively. - Be willing to relocate onsite at Amgens Hyderabad Genome Valley facility and support projects in India and other JAPAC countries. **Basic Qualifications:** - Doctorate degree in engineering or related technical field and 6 years of directly related experience OR - Masters degree in engineering or related technical field and 10 years of directly related experience OR - Bachelors degree in engineering or related technical field and/or 15 years of directly related experience **Preferred Qualifications:** - 5 or more years experience in project management for lab or manufacturing environments. - Broad knowledge and experience in design, planning, construct
As a Business Intelligence (BI) Developer in the Precision Medicine team at Amgen, your role will involve enabling data-driven decision-making across the scientific and R&D communities. You will be responsible for delivering enterprise-scale solutions for data standardization, data discovery, cohort building, analytics, and knowledge management, providing visibility into Amgens diverse ecosystem of clinical, omics, imaging, and research data. **Roles & Responsibilities:** - Design, develop, and maintain Power BI solutions including dashboards, reports, datasets, and semantic models. - Build scalable enterprise BI solutions using Power BI Desktop, Power BI Service, Power Apps, and Power Automate. - Optimize Power BI performance through efficient data modeling, DAX optimization, and query tuning. - Enable self-service analytics by designing reusable datasets and governed data models. - Design and develop analytics-ready data pipelines using Databricks and SQL. - Transform, cleanse, and curate structured and semi-structured data for BI and reporting use cases. - Collaborate with data engineering teams to ensure reliable, performant, and scalable data ingestion and transformation. - Implement data quality checks, validation rules, and monitoring to ensure data accuracy and consistency. - Leverage AWS services to support data storage, processing, and analytics workloads. - Design solutions that support secure, governed, and scalable data access across cloud environments. - Work with platform and security teams to align BI solutions with enterprise governance standards. - Partner with product owners, scientists, and business stakeholders to understand reporting and analytics needs. - Translate business requirements into clear BI and data solutions. - Support Agile delivery through backlog refinement, sprint planning, and demos. - Use Jira, Confluence, and DevOps tools to manage work, documentation, and releases. **Continuous Improvement:** - Continuously evaluate and improve BI standards, best practices, and reusable components. - Proactively identify opportunities to automate reporting and optimize data workflows. - Stay current with Power BI, Databricks, and cloud analytics advancements. **Must-Have Skills:** - Strong hands-on experience with Power BI (Power BI Desktop, Power BI Service, DAX, data modeling). - Experience integrating Power BI with Power Apps and Power Automate. - Hands-on experience with Databricks for data preparation and analytics. - Strong SQL skills for data transformation and analysis. - Solid understanding of data engineering concepts (ETL/ELT, data modeling, data quality). - Strong experience with AWS cloud services. - Experience working in Agile / SAFe environments. - Strong analytical, problem-solving, and communication skills. **Good-to-Have Skills:** - BI or analytics experience in biotechnology, pharma, or life sciences. - Experience designing enterprise semantic models and governed datasets. - Experience exposing curated data for downstream analytics or applications. - Familiarity with CI/CD practices for BI and data solutions. - Experience with performance tuning for large-scale analytical datasets. **Education & Professional Certifications:** - Masters degree with minimum 5 years of experience in Computer Science, IT, Data, or related field. - Bachelors degree with 7-10 years of relevant experience. **Preferred Certifications:** - Microsoft Power BI certification. - AWS Certified Data Engineer or related AWS certification. - Databricks certification. - SAFe or Agile certification. **Soft Skills:** - Excellent analytical and troubleshooting skills. - Strong verbal and written communication skills. - Ability to work effectively with global, cross-functional teams. - High degree of initiative and ownership. - Ability to manage multiple priorities in a fast-paced environment. - Team-oriented mindset with a focus on delivering business value. - Strong presentation and storytelling skills using data. In addition to the technical and professional requirements, this position may require you to work a later shift and may be assigned a second shift schedule. Candidates must be willing and able to work during evening or night shifts, as required. Amgen is an Equal Opportunity employer and is committed to providing reasonable accommodations to individuals with disabilities throughout the application, interview, and employment process. As a Business Intelligence (BI) Developer in the Precision Medicine team at Amgen, your role will involve enabling data-driven decision-making across the scientific and R&D communities. You will be responsible for delivering enterprise-scale solutions for data standardization, data discovery, cohort building, analytics, and knowledge management, providing visibility into Amgens diverse ecosystem of clinical, omics, imaging, and research data. **Roles & Responsibilities:** - Design, develop, and maintain Power BI solutions including dashboards,
As a Sr Associate Business Analyst at Amgen Global Supply Chain Analytics, you will play a key role in translating business needs into analytics and technology solutions. Your responsibilities will include: - Working with Data & Analytics Product team and customers to define scope and value for new developments and translating them into clear fit gap analysis - Writing actionable user requirements and defining user acceptance strategies for configurations, design, and implementation in analytical systems - Collaborating with business stakeholders for gating approvals, conducting roadshows, and evaluating requirements as fit & gap analysis - Capturing the voice of the customer to define business processes and product needs - Developing and executing effective product demonstrations for internal and external stakeholders - Maintaining accurate documentation of configurations, processes, and changes in solution documentation, workflows, and system configurations - Collaborating with geographically dispersed teams, including those in the US and other international locations - Being part of an Agile project team utilizing Agile/Scrum methodologies and working in a fast-paced, iterative environment - Partnering with Scrum Master, Product Owner, and the team in defining Technical User Stories and prioritizing enabler work Qualifications and Experience: - Masters degree with 5 to 8 years of experience in Supply Chain Technology, Supply Chain Business, Engineering, IT, or related field - Strong understanding of business analysis fundamentals, user story writing, and backlog grooming - Exposure to data pipelines, reporting logic, and metric definitions in a supply chain or operational context - Experience working with tools like JIRA, Confluence, or similar Agile collaboration platforms - Basic knowledge of data analysis tools (SQL, Excel) and familiarity with data visualization tools (Tableau, Power BI) - Excellent documentation and communication skills, with the ability to work across both business and technical teams - Knowledge of sprint-based planning and estimations required for implementation Soft Skills: - Strong leadership and team management skills - Transformation and change management experience - Exceptional collaboration and communication skills - High degree of initiative and self-motivation - Ability to manage multiple priorities successfully - Team-oriented with a focus on achieving team goals - Strong presentation and public speaking skills - Excellent analytical and troubleshooting skills - Strong verbal and written communication skills - Ability to work effectively with global, virtual teams Professional Certifications: - Business Analyst Professional (optional) Additionally, the following functional skills are required: - Health Cloud and Lifesciences Cloud hands-on experience - Working knowledge of integrations suite using APIs or 3rd party integration software like Talend, MuleSoft, Data Lake, and Data Fabrics - Extensive experience in software development lifecycle - Broad working knowledge of key IS domains and layers - Understanding of FDA regulations governing computer system validation and operation This role will provide you with the opportunity to contribute to the biotechnology industry and work in a collaborative and innovative environment. As a Sr Associate Business Analyst at Amgen Global Supply Chain Analytics, you will play a key role in translating business needs into analytics and technology solutions. Your responsibilities will include: - Working with Data & Analytics Product team and customers to define scope and value for new developments and translating them into clear fit gap analysis - Writing actionable user requirements and defining user acceptance strategies for configurations, design, and implementation in analytical systems - Collaborating with business stakeholders for gating approvals, conducting roadshows, and evaluating requirements as fit & gap analysis - Capturing the voice of the customer to define business processes and product needs - Developing and executing effective product demonstrations for internal and external stakeholders - Maintaining accurate documentation of configurations, processes, and changes in solution documentation, workflows, and system configurations - Collaborating with geographically dispersed teams, including those in the US and other international locations - Being part of an Agile project team utilizing Agile/Scrum methodologies and working in a fast-paced, iterative environment - Partnering with Scrum Master, Product Owner, and the team in defining Technical User Stories and prioritizing enabler work Qualifications and Experience: - Masters degree with 5 to 8 years of experience in Supply Chain Technology, Supply Chain Business, Engineering, IT, or related field - Strong understanding of business analysis fundamentals, user story writing, and backlog grooming - Exposure to data pipelines, reporting logic, and metric definit
Role Overview: You will be a Data Scientist at Amgen, responsible for developing, designing, and deploying AI-enabled forecasting models. Your role will involve applying deep technical expertise to scale forecasting models across Research & Development, Manufacturing, and Commercial departments to meet critical needs. You will work on manipulating large datasets, writing high-quality code, adapting machine learning models, and translating technical work into understandable outputs for key stakeholders. Key Responsibilities: - Be an integral part of a high-performing team of data scientists and engineers focused on translating machine learning algorithms into effective forecasting solutions - Conduct exploratory and targeted data analyses to identify patterns and anomalies - Develop high-performance forecasting algorithms, prototypes, predictive models, and proof of concepts using cutting-edge technical tools - Design and implement analytics pipelines following MLOps practices - Collaborate with data engineers on data quality assessment, data cleansing, and operational data pipelines development - Contribute ideas and methodologies to build the team and stay updated on industry and academia developments - Communicate effectively with technical, scientific, medical, and business stakeholders at different levels - Ensure compliance with regulatory, security, and privacy requirements related to data assets - Share findings and insights with team members and stakeholders Qualifications Required: - Experience in analyzing time-series data for forecasting and trend analysis - Proficiency in Python and relevant ML libraries such as TensorFlow, PyTorch, and Scikit-learn - Experience in designing, evaluating, and applying supervised and unsupervised machine learning models - Familiarity with Generative AI models and their applications in forecasting - Understanding of modern data stack tools like Spark, Hive, cloud computing environments, and Git - Proficiency in state-of-the-art machine learning tools, deep learning frameworks, transformer models, NLP models, and time series models - Experience with Databricks platform for data analytics and MLOps - Strong communication skills for presenting work clearly to a diverse audience Additional Company Details: Amgen is an Equal Opportunity employer that values diversity and inclusion. They provide reasonable accommodations for individuals with disabilities throughout the job application process, essential job functions, and other employment benefits and privileges. Role Overview: You will be a Data Scientist at Amgen, responsible for developing, designing, and deploying AI-enabled forecasting models. Your role will involve applying deep technical expertise to scale forecasting models across Research & Development, Manufacturing, and Commercial departments to meet critical needs. You will work on manipulating large datasets, writing high-quality code, adapting machine learning models, and translating technical work into understandable outputs for key stakeholders. Key Responsibilities: - Be an integral part of a high-performing team of data scientists and engineers focused on translating machine learning algorithms into effective forecasting solutions - Conduct exploratory and targeted data analyses to identify patterns and anomalies - Develop high-performance forecasting algorithms, prototypes, predictive models, and proof of concepts using cutting-edge technical tools - Design and implement analytics pipelines following MLOps practices - Collaborate with data engineers on data quality assessment, data cleansing, and operational data pipelines development - Contribute ideas and methodologies to build the team and stay updated on industry and academia developments - Communicate effectively with technical, scientific, medical, and business stakeholders at different levels - Ensure compliance with regulatory, security, and privacy requirements related to data assets - Share findings and insights with team members and stakeholders Qualifications Required: - Experience in analyzing time-series data for forecasting and trend analysis - Proficiency in Python and relevant ML libraries such as TensorFlow, PyTorch, and Scikit-learn - Experience in designing, evaluating, and applying supervised and unsupervised machine learning models - Familiarity with Generative AI models and their applications in forecasting - Understanding of modern data stack tools like Spark, Hive, cloud computing environments, and Git - Proficiency in state-of-the-art machine learning tools, deep learning frameworks, transformer models, NLP models, and time series models - Experience with Databricks platform for data analytics and MLOps - Strong communication skills for presenting work clearly to a diverse audience Additional Company Details: Amgen is an Equal Opportunity employer that values diversity and inclusion. They provide reasonable accommodations for individuals with disabilities throughout the
Role Overview: As an Associate IS Security Engineer at Amgen, you will play a crucial role within the Cybersecurity and Digital Trust (CDT) organization. Your primary responsibility will be to maintain and enhance the internal controls environment by collaborating with cross-functional teams to evaluate security risks and controls in information systems and projects. You will support various capabilities within the Governance, Risk and Compliance (GRC) team, focusing on risk management activities such as assessing security risks, recommending IT controls, and advising on control improvements. Key Responsibilities: - Bring innovative thinking, domain expertise, and a deep understanding of IT risks and controls to empower IT process and product owners in developing and maintaining secure and compliant IT solutions. - Advise project teams and application owners on information security risks and controls. - Participate in projects requiring security risks and controls expertise, ensuring appropriate security controls are implemented. - Evaluate compliance with security requirements and assess IT controls' design and implementation in various IT security processes. - Test the operating effectiveness of IT controls, including user access management, change management, and computer operations for complex IT systems. - Identify control deficiencies, assess risks, and suggest mitigating controls. - Document and communicate risks and risk mitigation actions effectively. - Utilize ISO and NIST information security frameworks to establish accountability and responsibility for controls within the information systems organization. - Ensure quality and timeliness across different functional deliverables, taking ownership of issues and seeing them through to completion. - Provide input based on industry best practices and experience to enhance security risk and controls areas. - Stay updated on emerging technological trends, security assessment, and risk management methodologies and standards. - Work hours are from 2 PM to 11 PM IST. Qualification Required: - Bachelor's degree and 3 years of directly related experience OR - Associate degree and 5 years of directly related experience OR - High school diploma / GED & 10 years of directly related experience Preferred Qualifications: - Bachelor's degree in computer information systems or computer science. - 2 years of IT audit, Information Technology / Security control assurance, or enterprise IT compliance experience. - Advanced industry-recognized security certification (i.e., CISA, CISM, CISSP, CRISC, Security, etc.). - Working knowledge of Information Security principles: confidentiality, integrity, and availability. - Knowledge of international standards for Information Technology and Information Security (i.e., ISO 2700x, NIST CSF, COBIT, ITIL, etc.). - Strong critical thinking skills for complex risk scenarios. - Ability to understand new technologies and propose appropriate controls and compliance mentorship. - Excellent written and verbal communication skills, including the ability to explain technical matters to a non-technical audience. - Detail-oriented with a focus on quality and ownership. - Exceptional teamwork skills in cross-functional environments. - Experience working in large/global corporate environments. - Fluency in English language. Additional Company Details: Amgen focuses on addressing areas of high unmet medical need, striving for solutions that improve health outcomes and enhance people's lives. As a biotechnology pioneer since 1980, Amgen has become one of the world's leading independent biotechnology companies, reaching millions of patients globally and developing a pipeline of medicines with significant potential. Amgen promotes a diverse and inclusive work environment, values collaboration, trust, empowerment, and inclusion. The company prioritizes employee well-being, offering industry-leading benefits for all employees, including transgender individuals and families of all compositions. Role Overview: As an Associate IS Security Engineer at Amgen, you will play a crucial role within the Cybersecurity and Digital Trust (CDT) organization. Your primary responsibility will be to maintain and enhance the internal controls environment by collaborating with cross-functional teams to evaluate security risks and controls in information systems and projects. You will support various capabilities within the Governance, Risk and Compliance (GRC) team, focusing on risk management activities such as assessing security risks, recommending IT controls, and advising on control improvements. Key Responsibilities: - Bring innovative thinking, domain expertise, and a deep understanding of IT risks and controls to empower IT process and product owners in developing and maintaining secure and compliant IT solutions. - Advise project teams and application owners on information security risks and controls. - Participate in projects requiring security risks and