At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**Job Summary**
We are seeking an Associate Director of Intelligent Solutions Engineering to lead delivery teams and initiatives building AI-powered platforms and cloud applications that streamline clinical trial processes and accelerate medicine delivery to patients. In this hands-on technical leadership role, you will oversee the architecture and development of custom products that automate workflows, enable data-driven decisions, and extract insights from diverse data sources. You'll drive technical execution by working directly with engineers, data scientists, business users, and cross-functional stakeholders to deliver robust, scalable, and maintainable solutions. This role requires balancing innovative AI technologies with real-world application requirements, ensuring our platforms are both technically sound and usable while aligned with business objectives.
**Key Responsibilities**
+ Lead technical strategy, roadmap, and architecture for scalable, cloud-native software solutions across onshore and offshore engineering teams.
+ Partner with data science teams and business stakeholders to identify priorities and modernize processes.
+ Communicate technical vision to align and influence cross-functional teams and senior stakeholders.
+ Architect and implement platforms that integrate, analyze, and visualize data using serverless, modern web technologies, and full-stack AWS deployments.
+ Serve as technical subject matter expert for AI solutions, including Generative AI applications, context engineering, document generation, and agentic workflows.
+ Drive end-to-end product development from inception through production deployment and maintenance.
+ Establish and enforce software engineering standards, design patterns, and architectural principles.
+ Implement automation-first DevOps practices and champion continuous improvement initiatives.
+ Oversee offshore vendor partnerships to ensure quality delivery and product sustainability.
+ Mentor engineering teams on AI-driven software development practices and establish best practices for code quality, testing, and documentation, including training on AI tooling and implementation.
+ Research and apply emerging AI technologies and innovative approaches to solve complex technical challenges.
**Basic Qualifications**
+ BA/BS with at least 10 years of relevant experience, MA/MS/MBA with at least 8+ years of relevant experience, or PhD with at least 2 years of experience.
+ 4+ years of cross-functional technical project management or other relevant leadership experience in a business environment, including multiple years managing project teams.
+ Expert-level understanding of software engineering fundamentals including data structures, algorithms, complexity analysis, and system design principles.
+ Proven experience leading full SDLC implementations across multiple methodologies (Agile/Scrum, waterfall, hybrid) and product development lifecycles.
+ Advanced Python proficiency building production REST APIs and async systems; working knowledge of modern frontend frameworks (React preferred).
+ DevOps proficiency with CI/CD automation (GitHub Actions, Terraform), containerization (Docker), and cloud security best practices (IAM, secrets management, network security).
+ Production AWS expertise: serverless architectures (Lambda, ECS), storage solutions (S3, RDS, DynamoDB), and infrastructure-as-code (Terraform).
+ Data integration engineering including API development, middleware solutions, event-driven architectures, and automated data synchronization pipelines.
+ Generative AI expertise with LLMs, prompt engineering, and frameworks (LangChain).
+ Proficiency with AI-powered development tools (GitHub Copilot, Cursor, Claude) for accelerated code generation and refactoring.
**Preferred Qualifications**
+ Experience working in or alongside clinical, regulatory, or real-world evidence (RWE) functions.
+ Familiarity with GxP, 21 CFR Part 11, and other relevant compliance frameworks.
+ Experience with AI/ML applications in healthcare, including model evaluation, validation frameworks, and integration of multimodal data sources.
**What You'll Gain**
You'll have the opportunity to shape technical strategy at the intersection of software architecture and AI, working on transformative projects that deliver real business impact. This role offers the chance to build strong cross-functional relationships while staying at the forefront of emerging AI technologies. You'll develop your ability to bridge technical and business contexts, lead high-performing teams, and drive meaningful results through a pragmatic, value-focused approach to innovation-all while maintaining the technical depth to contribute from architecture to code.
The salary range for this position is:
Bay Area: $195,670.00 - $253,220.00.
Raleigh: $168,980.00 - $218,680.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
**For jobs in the United States:**
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (********************************************** poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (*********************************************************
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
$195.7k-253.2k yearly 4d ago
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Manager, IT Engineering
Gilead Sciences 4.5
Gilead Sciences job in Raleigh, NC
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matters and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work.
Summary:
This role sits within the global Gilead IT organization within the US Commercial Field Enablement IT team with the primary responsibility of supporting IT operations for Field Enablement applications. This role reports to the US Commercial IT Field Enablement lead.
This role will support and liaise with a broad business team including Gilead Commercial Operations, Medical Affairs and Business Conduct. The role will also engage across IT teams who manage/support systems within the Capability ecosystem, i.e., integration touchpoints with tools such as Master Data Management platform and Commercial Analytics Hub as well as the broader IT team that enable the overall working experience for the business teams we support.
This role would act as a liaison between CRM, Events and Account Management capability leads and the vendor MSP teams to manage and deliver on IT operations for field applications. This role would enable Next Gen CRM program by consolidating IT operations for field applications, quickly identifying and mitigating end user impacts and enabling focus on field experience with technology and IT change management.
Some of the key activities that this role would lead include managing IT support operations teams, tracking and reporting on service requests and incidents, providing hands-on support and oversight for complex / priority tickets and escalations, participating in system testing and user acceptance testing, and managing deployment and hypercare.
Core Tasks, Responsibilities & Scope of Authority:
Utilize ServiceNow to record and track incidents, service requests including report requests
Hands-on leadership and execution of IT support operations activities, working with MSP resources
Engage with offshore service teams and onshore business and IT partners daily to deliver support operations
Build and maintain a track of operational requests over time to advise leadership on trends with a key metric around first call resolution, warm transfers and minimizing field user time spent chasing IT support issues
Support field events such as National Sales Meeting with onsite presence when necessary
Proactive readiness and planning to support new product launches including onboarding field user groups
Support launch of new applications such as Veeva Align, Next Gen CRM, ongoing platform and application enhancements
Build and maintain relationships with individual field users and other support groups and product teams
Lead IT operations for the field teams in a secure and compliant manner, adhering to appropriate SOPs and work instructions
Additionally:
Works closely with the respective Product Owners for Veeva / Vault CRM, Events Management, Align and other field applications to ensure end user experience for field applications remains positive
Leads operational reporting services delivered within the platform / application using Salesforce / Vault platform reporting, MyInsights / X-Pages
Basic Qualifications:
Doctorate OR
Master's and 4+ years of relevant experience OR
Bachelor's and 6+ years of relevant experience OR
Preferred Qualifications:
Strong techno-functional knowledge of Veeva Commercial Cloud, including but not limited to Align, Veeva / Vault CRM, Veeva Events Management as well as Salesforce platform, Vault platform
Strong problem-solving skills, experience in identifying and preventing issues from recurring, debugging and fixing code
Ability to prioritize incidents and service requests based on priority levels and knowledge of support escalation paths
High level of personal integrity consistent with Gilead's core values (Excellence, Accountability, Teamwork, Integrity and Inclusion)
Service-oriented, willingness to put in the extra yards to provide an outstanding experience to end users
Experience working in a multi-vendor scenario; vendor management experience is a plus
Strong communication skills to engage directly with business users, IT and vendor teams
Knowledge of ITIL framework and best practices
Knowledge of working with ServiceNow IT service management platform
The salary range for this position is: $126,565.00 - $163,790.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
$126.6k-163.8k yearly Auto-Apply 37d ago
Senior Production Scheduler, CVRM (Holly Springs)
Genentech 4.5
Holly Springs, NC job
Pharma Technical Manufacturing (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. 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
We're looking for a highly skilled Master Production Scheduler/Senior Production Scheduler to join our team. In this role, you'll be responsible for developing and maintaining the master production schedule, ensuring we meet customer demand while optimizing our production resources. You'll be a key player in our supply chain, bridging the gap between sales, operations, and procurement.
As part of plant start-up you will act as the Materials Management PLAN main functional contact for the SAP ERP deployment; responsible for the timeline, deliverables, and adherence to the global template processes.
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.
You will create and maintain a feasible Master Production Schedule (MPS) for key finished goods and components, balancing customer demand with production capacity. Use inputs from the sales forecast, customer orders, and inventory targets to drive the schedule.
You will assess and manage production capacity, identifying and resolving any bottlenecks. Work closely with production managers to ensure the MPS is achievable.
You will partner with the procurement team to ensure timely availability of raw materials and components needed for production. Monitor inventory levels and adjust the MPS as needed to prevent stockouts or excessive inventory.
You will utilize SAP S/4HANA for planning and execution, and OMP for advanced planning and scheduling. You'll need to be proficient in these systems, generating reports, analyzing data, and making informed decisions.
You will serve as the primary liaison between sales, operations, finance, and procurement. You'll communicate changes to the schedule, manage expectations, and facilitate a smooth production flow.
You will monitor and report on key performance indicators (KPIs) such as production attainment, schedule adherence, and inventory accuracy. Use this data to identify areas for continuous improvement.
You will apply standard APICS (Association for Supply Chain Management) principles and best practices in all aspects of master scheduling. A strong understanding of planning, scheduling, and inventory management concepts is essential.
You will lead site function activities for SAP deployment fit-to-template, design, test, SOP development, go-live, and hypercare
Who You Are
You hold a Bachelor's degree in Supply Chain Management, Operations, Business, or a related field with 8-10 years in a master production scheduler or similar supply chain planning role..
You have proven experience with ERP planning processes and software (eg. SAP S/4HANA and OMP) is required.
You have strong analytical and problem-solving abilities, with the capacity to analyze complex data and make data-driven decisions.
You have excellent communication and interpersonal skills, with the ability to effectively collaborate with various teams and stakeholders.
Preferred
You have a CPIM (Certified in Planning and Inventory Management) or CSCP (Certified Supply Chain Professional) certification
You have an advanced degree (eg. Masters, MBA)
You have experience with the implementation of large scale ERP projects a plus
The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina $91,070 - $169,130. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Relocation benefits are provided.
Link to Benefits
Relocation benefits are provided
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.
$60k-74k yearly est. Auto-Apply 60d+ ago
Associate Manufacturing (Day Shift)
Amgen 4.8
Holly Springs, NC job
Career CategoryManufacturingJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Associate Manufacturing (Day Shift)
Live
What you will do
Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be 10 hours shift Mon to Friday 6am to 4pm. The schedule will transition to a 12-hour night shift including every other weekend as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.
Please note; no relocation assistance will be provided for these positions.
With general direction, the Associate will support all floor operations in accordance with cGMP practices.
Responsibilities will include...
Compliance:
Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance
Assure proper gowning and aseptic techniques are always followed
Process/Equipment/Facilities:
Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area
Run and monitor critical process tasks per assigned procedures
Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions
Perform documentation for assigned functions (i.e., equipment logs, EBRs)
Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities
Maintain an organized, clean, and workable space
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications.
Basic Qualifications:
High School/GED + 2 years manufacturing and/or other regulated environment experience
Or
Associate's Degree + 6 months manufacturing and/or other regulated environment experience
Or
Bachelor's Degree
Preferred Qualifications:
Completion of NC BioWork Certificate Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility
Excellent verbal and written communication
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
No relocation assistance will be provided for these positions
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
#AmgenNorthCarolina
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
75,618.00 USD - 89,473.00 USD
$26k-35k yearly est. Auto-Apply 14d ago
R-196991 Mfg Specialist
Amgen 4.8
Holly Springs, NC job
Additional Information
All your information will be kept confidential according to EEO guidelines.
$42k-58k yearly est. 5m ago
Senior Epidemiologist, Oncology, Breast Cancer, Real World Evidence - FSP (Sponsor Dedicated)
Iqvia 4.7
Durham, NC job
Join IQVIA's Sponsor-Dedicated FSP team and help advance healthcare through real-world evidence. We bring together scientific expertise and real-world data to help sponsors make decisions and accelerate evidence generation to improve patient outcomes. In this role, you'll work closely with one sponsor, gaining deep knowledge of their therapies while leveraging IQVIA's global expertise.
Overview:
Design and conduct epidemiological studies to generate real-world evidence within time, budget, and quality standards, including but not limited to natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies. Skill sets of the Epidemiologist role are similarly required, with the expectation of more experience, able to operate strategically under limited supervision, well versed in current Epidemiology research methods, deep understanding of how RWE fits within drug development, regulatory, medical, safety and other functions.
Responsibilities:
Lead development of study protocols, analysis plans, and study reports to answer research questions of priority to RWE.
Lead, design, and manage epidemiological, biomarker and/or data science projects.
Lead, plan, design, and conduct analyses for internal and external decision making (e.g., responses to regulatory authorities, rapid analyses of safety queries).
Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy.
Constructed cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed.
Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers.
Support the effective communication of study/analysis results to support internal and external decisions.
Coauthor abstracts and manuscripts for external dissemination of methodologic study results.
Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities.
Technical Expertise:
Observational research methods (both Primary and Secondary), deep knowledge of biostatistics and analysis methods, understanding of regulatory processes. o Ability to design studies independently, (i.e., ability to translate research questions to create study design).
Subject Matter Expertise:
Provide subject matter expertise and conduct analyses for descriptive and comparative research using RWD (examples include claims, EHR, PRO/COA, registry data) for methodologic research questions.
Lead the design and execution of post-marketing and observational safety studies to evaluate product risk profiles and inform regulatory and clinical decision-making.
Contribute to engagements with regulatory authorities to provide scientific input, respond to safety-related inquiries, and ensure compliance with evolving regulatory requirements.
Requirements:
PhD in Epidemiology with a minimum of four (4) years of post-doctoral experience, preferably at a pharmaceutical company. Master's degree in Epidemiology plus 7-9 years of experience in lieu of PhD may be acceptable.
Oncology Specific: expert knowledge and extensive experience (at least 2+ years leading studies) with cancer epi (solid tumor experience a plus), extensive experience with oncology EMR databases, extensive experience with conducting cancer epi studies.
Pharmaco Epidemiology Specific: expert knowledge and extensive experience with pharmacoepi methods (i.e., signal detection and validation methods), expert understanding of regulatory requirements for safety reporting and analysis, RMPs, and PASS both US and global.
Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development.
Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases.
A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred.
Demonstrated ability to function with an increasing level of autonomy and to develop productive cross- functional collaborations in a matrix environment.
Ability to manage priorities and performance targets.
What's in it for you?
Be part of a forward-thinking team that helps shape the next generation of evidence-based healthcare.
Work hand-in-hand with one leading sponsor, gaining deep expertise in their therapies.
Access IQVIA's global network who supports your growth.
This is your chance to make an impact, while building a career that matters.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $110,500.00 - $276,100.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
$69k-98k yearly est. Auto-Apply 12d ago
Manufacturing Procurement Site Lead
Amgen 4.8
Holly Springs, NC job
Career CategoryProcurementJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Manufacturing Procurement Site Lead
What you will do
Let's do this. Let's change the world. We are seeking an individual who thrives in ambiguity and is capable of driving procurement outcomes in a manufacturing operations environment with strategic vision and precision. In this vital role you will oversee the operations and management of manufacturing procurement at one of Amgen's world class global manufacturing sites. This position will play a key role in ensuring procurement deliverables support effective and efficient site-based manufacturing activities, while maintaining compliance with regulatory requirements, and driving continuous improvement in manufacturing operations. Reporting to the Manufacturing Site Lead within Internal & External Manufacturing, you will also act as the lead procurement business partner for the Site Head and their functional and cross-functional leadership team, connecting procurement outcomes to strategic business objectives at the site.
Roles & Responsibilities:
Drive continuous improvement Procurement initiatives by identifying inefficiencies, recommending solutions, and implementing changes to enhance manufacturing performance, speed, and delivery.
Champion a multi-year pipeline of savings and value plans across the manufacturing site that alignment with category and business strategies delivered against Finance's annual budget plan
Be a trusted advisor across the Site Leadership Executive teams - ability to grow and maintain influence of Sourcing Agenda and delivered through strategic business partnership
Be a Procurement leader with strong financial competence, experienced with accountability to site Executives and cross-functional leaders
Lead with a commitment to continuous improvement in sourcing processes, tools and operating model; Develop goals and prioritize impact to site work among multiple initiatives; Courage to provide performance feedback across the category and sourcing teams
Connect the dots and translate central functional programs into site based deliverables and outcomes
Champion supplier relationship management for critical suppliers at the site level
Identify and mitigate supply risk while ensuring Procurement deliverables adhere to regulatory requirements (e.g., GLP, GMP, ISO) and implement quality control systems, including audits, inspections, and compliance-related activities.
Monitor and report on Procurement performance metrics, making necessary adjustments to meet organizational goals and identifying opportunities for cost savings and process improvements.
Evaluate and implement, through Procurement, process improvement, environmental sustainability, and automation initiatives to enhance operational efficiency and support long-term goals.
Maintain up-to-date knowledge of industry standards and best practices, sharing innovative procurement solutions within the global manufacturing operations network.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
Or
Master's degree and 4 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
Or
Bachelor's degree and 6 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
Or
Associate's degree and 10 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
Or
High school diploma / GED and 12 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
Preferred Qualifications:
In-depth knowledge of procurement best practices across manufacturing, capital, equipment, and technologies.
Familiarity with industry standards and regulations (e.g., GLP, GMP, ISO, OSHA).
Proven track record to drive value in a procurement environment supporting manufacturing
Strong analytical skills to monitor performance metrics, optimize procurement deliverables, and ensure compliance.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $145,239 to $170,803. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
-
$145.2k-170.8k yearly Auto-Apply 60d+ ago
IQVIA - Per Diem - MedTech Travel Clinical Educator - Raleigh, NC
Iqvia 4.7
Raleigh, NC job
We welcome you to apply if interested! You will be asked to create an account, which takes less than one minute and requires only a username and password. The entire application takes no more than 5-7 minutes to complete.
Job Description:
Our RN Clinical Educators experience a unique opportunity to employ their clinical nursing expertise in a new way outside patient care, while continuing to collaborate with healthcare professionals and advocate for the well-being of patients through medical device technology. You will be responsible for training and educating Registered Nurses and Physicians on a new medical device primarily used in the Infusion, Vascular Access, Critical Care unit(s) setting.
Your primary focus will be in-servicing and education only; no sales responsibilities, and no bedside care.
A desire to expand your talents in clinical education.
Per-diem position requiring travel and flexibility to work with your current schedule.
Minimum availability of 2 weeks per month required.
Travel regionally and nationally to support customer needs..
IQVIA takes the approach to helping customers drive healthcare forward in this challenging, fast-paced environment. We help customers accelerate results, improve patient outcomes, and unleash new opportunities.
Responsibilities:
Provide peer-to-peer education and in-servicing to nurses, physicians, and hospital staff to support medical device implementations
Assess customer-specific education needs and collaborate with staff to deliver a positive educational experience
Utilize clinical nursing expertise to answer questions and address concerns with the medical device
Provide updates, reports, and valuable feedback to client during and after in-service assignments
Job Requirements:
RN Degree - Associates required, Bachelor's preferred
Active and Unrestricted RN license required
Infusion or Vascular Access experience of at least 3-5 years required
Critical Care unit experience of at least 2 years is preferred
Leadership experience (manager, educator, preceptor) can be helpful but is not required
Must be comfortable with basic software programs
Ability to travel locally, regionally, and nationally
You will have a flexible schedule, an opportunity to travel, grow and expand into new opportunities while earning supplemental income and learning the medical device industry.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role is $36-38 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
$36-38 hourly Auto-Apply 43d ago
Senior Associate Facilities Maintenance
Amgen 4.8
Holly Springs, NC job
Career CategoryMaintenanceJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Associate Facilities Maintenance
What you will do
Let's do this. Let's change the world. In this vital role, you will be part of the Facilities organization within the Facilities & Engineering (F&E) team at Amgen's newest manufacturing site in North Carolina!
System Owner responsibilities for facilities and utilities infrastructure systems including Building Shell & Core, Fire Protection & Suppression, Fire Alarm, Domestic Water, Sewer, etc, and supporting operations at the site.
Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems.
Support day-to-day logistics and overall coordination within the department and with project team. Attendance to whiteboard meetings, support and communication with the team.
Ability to support end-to-end process for the creation of the Master Maintenance Packages including, but not limited to:
Construction inspection walks
Commissioning documentation
Develop equipment/instrument maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order.
Asset Creation / Preventive Maintenance Creation / Job Plan creation and overall ownership of systems within the Computerized Maintenance Management System (CMMS)
Define spare parts' list, responsible for assessment with regards to criticality of spares
Develop and assist in redlining and workflow process for SOP's relevant to the Facilities department
Collaborate with peers to streamline or construct efficient Workflows/Business Practices
Support of field walks, and general activities leading up to and at startup of systems; which includes but it is not limited to inspection field walks, punch list items generation, and inspection of equipment for Mechanical Completion
Work with technicians and system owners to develop the scope of work, resource requirements, and parts requirements to complete preventive and corrective maintenance tasks in a safe, compliant, efficient, and effective manner
Write clear, concise, and accurate Job Plan steps within the CMMS for corrective and preventive maintenance work orders
Review turnover documentation and observe/document required spare parts for commissioning runs and future state operations
Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.
Collaborate with integrated facilities management team and craft groups to schedule maintenance activities as required to support site operations
Support maintenance activities to allow efficient labor utilization of F&E crafts while minimizing the interruption to customer operations. Identify and coordinate contractor resources as needed to effectively complete tasks
Overall Facilities Compliance:
Owner for Facilities Standard Operating Procedures
Responsible for reviews, updates and administration of SOP's for Facilities Department
Owner of change controls - end to end process
Owner of deviations and corrective actions
Assist with Procurement and Invoicing for the department
Provide technical support and issue resolution with 24x7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays).
Data verification of GMP information for pest control compliance
Delegate for Facilities Sr Manager during period of absence
Day-to-day management of communication and any other tasks/projects assigned as per manager's request
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications.
Basic Qualifications:
High School Diploma / GED and 6 years of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR
Associate's Degree and 4 years of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR
Bachelor's Degree and 2 months of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR
Master's Degree
Preferred Qualifications:
Experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of current Good Manufacturing Practices
Strong customer service skills, written and verbal communication skills, and the ability to work with minimal direction
Demonstrated ability to function within cross-functional teams and embrace a team-based culture
Ability to use Microsoft Excel, Word, PowerPoint, SharePoint, Smartsheet, and various database querying tools
Good understanding of CMMS systems (Maximo, SAP, Blue Mountain, ETC.)
Familiar with Root Cause Analysis and LEAN methodology
Excellent facilitation, organizational and planning skills
Proactive, self-starter with the ability to take on several projects at one time
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
94,978.00 USD - 114,953.00 USD
$73k-95k yearly est. Auto-Apply 8d ago
Director, Statistical Programming
Gilead Sciences, Inc. 4.5
Gilead Sciences, Inc. job in Raleigh, NC
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.
We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.
Director, Clinical Data Science - SAS Macro and Data Operations leads the end-to-end strategy, development, qualification, and lifecycle management of Statistical Programming tools, macro libraries, applications and automation solutions that accelerate clinical analysis and reporting. The role owns a multi-disciplinary team spanning statistical programming, data engineering, and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory, and Quality to ensure compliant, efficient, and scalable delivery. Core technologies include SAS Macros, Python, Linux scripting, and modern cloud services.
Key Responsibilities:
Strategic Leadership & Team Management
* Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers (including Linux scripting, Python console, and web applications) to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions.
* Set clear goals, conduct performance assessments, and foster professional growth and continuous learning within the team.
Programming Oversight & Technical Excellence
* Oversee the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs).
* Ensure programming infrastructure is robust, scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility and audit readiness.
* Promote automation and standardization of programming workflows to improve efficiency and consistency across studies.
Project Delivery & Resource Management
* Accountable for the timely and quality completion of all programming deliverables across assigned projects and studies, including resource allocation and prioritization.
* Manage project timelines, budgets, and external vendor relationships as needed.
Cross-Functional Collaboration
* Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity.
* Represent the statistical programming function in cross-functional meetings and strategic initiatives.
Process Optimization & Innovation
* Lead the development and implementation of programming standards, best practices, and innovative solutions (including cloud-based platforms, AI/ML, and automation pipelines) to enhance efficiency and quality.
* Evaluate and integrate emerging technologies into statistical programming workflows.
Compliance, Documentation & Quality Assurance
* Ensure all programming activities adhere to SOPs, regulatory requirements, and internal quality standards; maintain audit readiness and documentation for all deliverables.
* Oversee code quality, version control, and documentation governance frameworks.
Stakeholder Engagement & Training
* Provide technical guidance and training on advanced programming techniques, tools, and industry trends to team members and stakeholders.
* Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables.
Basic Qualifications
PhD / PharmD and 8 years of experience
OR
Master's and 10 years of experience
OR
Bachelor's and 12 years of experience
Preferred Qualifications:
* Education: BS/MS/PhD in Biostatistics, Computer Science, or related field; advanced degree preferred.
* Technical Skills: Expert in SAS Macros and strong proficiency in Python; working knowledge of R and Linux scripting; familiarity with AWS Cloud.
* Core Competencies: Strategic thinking, cross-functional influence, compliance mindset, talent development, user-centric engineering.
People Leader Accountabilities:
* Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
* Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
* Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
The salary range for this position is:
Bay Area: $210,375.00 - $272,250.00.
Raleigh: $181,730.00 - $235,180.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
$210.4k-272.3k yearly Auto-Apply 28d ago
Senior Manager Quality Assurance - Incoming Quality Raw Materials /Disposition
Amgen 4.8
Holly Springs, NC job
Career CategoryQualityJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Manager Quality Assurance - Incoming Quality Assurance Raw Materials /Disposition
What you will do
Let's do this! Let's change the world!
In this vital role, you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations.
Specific responsibilities include but are not limited to:
Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations).
Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements.
Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring.
Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations.
Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays.
Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact.
Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program.
Represent the Quality unit during internal and external audits and regulatory inspections.
Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed.
Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong leader with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR
Associate's degree and 10 years of Quality and Manufacturing support industry experience OR
Bachelor's degree and 8 years of Quality and Manufacturing support industry experience OR
Master's degree and 6 years of Quality and Manufacturing support industry experience OR
Doctorate degree and 2 years of Quality and Manufacturing support industry experience
Preferred Qualifications:
Educational background in Life Science and/or Engineering
Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems.
In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice.
Hands-on experience with Disposition, Incoming, and Quality Systems-particularly investigations, corrective actions, and audit readiness.
Experience managing and interacting with regulatory and internal auditors.
Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills.
Effective risk management, negotiation, and cross-functional collaboration abilities.
Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
154,692.00 USD - 188,725.00 USD
$102k-132k yearly est. Auto-Apply 13d ago
Process Development Senior Associate I
Amgen 4.8
Holly Springs, NC job
Career CategoryScientificJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Process Development Senior Associate
What you will do
Let's do this. Let's change the world. In this vital role you will work in a team environment to contribute to drug substance process development
Execute mammalian cell culture experiments at different scales in shake flasks and bioreactors
Execute purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed
Document experimental data in lab notebooks
Communicate findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings)
Contribute to technology development projects to seek continuous improvement in reliability and efficiency
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications.
Basic Qualifications:
High school diploma / GED and 6 years of life sciences industry experience OR
Associate's degree and 4 years of Quality Control experience OR
Bachelor's degree and 2 years of Quality Control experience OR
Master's degree
Preferred Qualifications:
Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing field or relevant experience in the pharmaceutical or related industry preferred.
Relevant hands-on lab experience in cell culture or protein purification.
Proven ability to identify and tackle problems by applying scientific and engineering principles, preferably in a process development environment
Experience in Design of Experiments and statistical analysis is a plus.
Good oral and written communication skills.
Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
86,613.00 USD - 104,742.00 USD
$68k-82k yearly est. Auto-Apply 12d ago
Specialist Manufacturing: NPI, Process Owner
Amgen 4.8
Holly Springs, NC job
Career CategoryManufacturingJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Specialist Manufacturing: NPI, Process Owner
What you will do
Let's do this. Let's change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC's Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANC's biologics manufacturing facility and ownership of downstream unit operations. It is a highly visible role across the site with the core responsibility of hosting cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations.
New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet).
Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes
Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion. Responds to regulatory questions and/or audit findings.
Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics Drug Substance Downstream manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications.
Basic Qualifications:
High school diploma / GED & 10 years of biotechnology operations experience OR
Associate's degree & 8 years of biotechnology operations experience OR
Bachelor's degree and 4 years of biotechnology operations experience OR
Master's degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR
Doctorate degree
Preferred Qualifications:
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent cross-functional project management, meeting facilitation, and technical writing skills
Experience in Downstream GMP manufacturing operations
Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing.
Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc.
Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms
Ability to coach, mentor and/or cross train colleagues within core technical areas
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
112,977.00 USD - 139,179.00 USD
$60k-82k yearly est. Auto-Apply 60d ago
Director, Engineering
Amgen 4.8
Holly Springs, NC job
Additional Information
All your information will be kept confidential according to EEO guidelines.
$136k-189k yearly est. 7m ago
Associate Scientist, Process Development (Process Validation & Business Strategy)
Amgen 4.8
Holly Springs, NC job
Career CategoryProcess DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Associate Scientist, Process Development (Process Validation & Business Strategy)
What you will do
Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen's FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes process development operation support, developing digital tools to support business processes, and support commercial development of Amgen's pipeline.
The role will be responsible for ensuring PD business strategy operations have appropriate digital tools to track operational metrics for safety, training, compliance, support business processes improvements, and the commercial development of the Amgen's pipeline. In addition, the role will be responsible for supporting tech transfer activities as needed.
Lead and develop the Process Development safety, training, and compliance monitoring operation
Holistic Lab Execution Environment (HLEE) champion for the process development lab
Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation
Develop digital tools to support process validation and process monitoring activities
Support and develop the Amgen North Carolina (ANC) PD DST knowledge management ecosystem, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process.
Provide process floor or lab support as required
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications.
Basic Qualifications:
Bachelor's degree and 3 years of Process Development or Scientific experience OR
Master's degree and 1 years of Process Development or Scientific experience
Preferred Qualifications:
2 - 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role.
Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes
Familiarity in operational aspects of process development lab or commercial biopharma manufacturing
Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, spotfire, and/or databricks
Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements
Excellent written and verbal communication
Be a self-starter with the ability to take on several projects at one time.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
97,377.00 USD - 118,653.00 USD
$57k-82k yearly est. Auto-Apply 13d ago
Senior Manufacturing Systems Engineer
Amgen 4.8
Holly Springs, NC job
Career CategoryInformation SystemsJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Senior Manufacturing Systems Engineer
What you will do
Let's do this. Let's change the world. In this vital role you will be part of Amgen's most technologically advanced drug substance manufacturing plant. The facility continues to expand in size and advance with embedded new technologies and industry 4.0 capabilities facility wide.
As a Senior Manufacturing Systems Engineer, you will:
Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions.
Collaborate with business partners to understand how automation can improve workflow and productivity. Synthesize requirements from clients, customers or end-users to develop the best automation solutions.
Lead and support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility
Lead and support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes and supporting engineering and process qualification runs as applicable.
Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units.
Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment.
Ability to anticipate, evaluate and resolve project issues, delays, and problems by using technical, project management, and business expertise. Manage multiple initiatives and priorities.
Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.
Basic Qualifications:
Doctorate degree OR
Master's degree and 2 years of Manufacturing Process automation/Information system experience OR
Bachelor's degree and 4 years Manufacturing Process automation/Information system experience OR
Associate's degree and 8 years of Manufacturing Process automation/Information system experience OR
High school diploma / GED and 10 years of Manufacturing Process automation/Information system experience
Preferred Qualifications:
Demonstrable experience in a manufacturing environment with ability in the Pharmaceutical or Biotechnology industries.
Direct knowledge of Automation design, experience in process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems such as media, harvest, bioreactors, chromatography, vial filtration, and ultrafiltration/diafiltration, and integrating various OEM automation software packages.
Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
Experience with Emerson Delta-V DCS system, Process Control Network design including network segregation, and Process Control System Virtual Infrastructure design and implementation.
Demonstrable understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies to establish a PCS and MES implementation and Systems Integration that meets Operations' business requirements.
Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution.
Demonstrated hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations.
Position requires an in-depth knowledge and hands-on coding experience of Emerson Delta V Platform in particular, and on Rockwell FactoryTalk, Rockwell PLC's. Aveva PI Data Historian knowledge is preferred.
Kneat platform-based C&Q documentation development knowledge a plus
The ideal individual must be a self-directed team player ready to mentor and develop engineering staff and embrace a team-based culture that relies on collaboration for effective decision-making.
Strong leadership, technical writing, and communication/presentation skills.
What you can expect from us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#CLOLI
.
Salary Range
135,728.00 USD - 159,431.00 USD
$77k-100k yearly est. Auto-Apply 60d+ ago
Senior Medical Science Liaison- Autoantibody Pipeline-South
Johnson & Johnson 4.7
Raleigh, NC job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Medical Affairs Group
Job Sub Function:
Medical Science Liaison
Job Category:
Scientific/Technology
All Job Posting Locations:
Nashville, Tennessee, United States, Raleigh, North Carolina, United States
Job Description:
Johnson & Johnson Innovative Medicine is searching for the best talent for a Senior Medical Science Liaison- Autoantibody Pipeline for the South region. This is a field-based position located in the South region, the preferred location is the Raleigh, NC or Nashville, TN area. The territory covers Louisiana, Arkansas, Mississippi, Kentucky, Tennessee, North Carolina, South Carolina, and Virginia.
About Immunology
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine.
The Senior Medical Science Liaison (Sr. MSL) is responsible for providing fair balanced, objective, scientific information and education to opinion leaders (OLs), health care professionals, and to internal partners as required by scientific and business needs. The Sr. MSL is considered an established scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per Therapeutic Area (TA) alignment. Sr. MSL is responsible for staying abreast of current scientific and treatment landscape trends in their therapeutic areas of interest. Sr. MSL provides research support for company and investigator-initiated research. The Sr MSL will function with high integrity and follow credo values.
Sr. MSL is responsible for building external relationships with identified OLs and health care providers (MD, DO, PhD, PA, NP, RN, Pharm.D., bio coordinators) and developing and managing a geographical territory. These relationships and engagements can include both virtual & in-person, with a prioritization of in-person engagements when appropriate.
The Sr. MSL is responsible for developing and maintaining a territory strategic plan, which includes educational activities with identified OLs, HCPs, institutions, and community practices.
The Sr. MSL role is one that requires a level of competency and experience in the disease state. The Sr. MSL is expected to possess foundational competencies in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination.
The Sr. MSL will be expected to rapidly identify and compliantly collaborate with field-based partners to ensure support of the Healthcare Providers, which will positively impact the patients that they care for.
The Sr. MSL will continue to enhance their skills in agility, applying the competencies of Change Management, Time Management and Innovation.
The Sr. MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines.
This is a field based clinical position which required travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 70%.
Responsibilities:
Consistently demonstrate strategic territory planning and ability to build strong relationships within the territory.
* Responsible for developing and maintaining a field strategic plan.
* Responds in a timely manner to unsolicited scientific inquiries of HCPs/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence into real life practice to meet customer needs.
* Presents data and information in a manner appropriate to the audience and request.
* Execute plans regarding reactive and proactive outreaches as approved via the legal/HCC exceptions process.
* Integrates scientific data into real life practice to meet customer/audience needs, adapting interpersonal style to particular situations and people.
* Anticipates the responses of various individuals and teams based on their vantage point and perspective.
* Prioritize franchise customer-based initiatives and field responsibilities, while balancing administrative duties and project responsibilities.
* Executes Research Initiatives:
* Leverages knowledge of standards of care and Janssen company/investigator sponsored clinical trials and competitor landscape to facilitate external-internal research communication.
* Engages with external investigators regarding unsolicited research inquiries and act as liaison to R&D, Medical Affairs and operations teams.
* Provides clinical trial support to identify potential sites, resolve issues with enrolled sites, and participate in meetings as appropriate, including site initiation visits and investigator launch meetings.
* Effectively leads at least one scientific or strategic Immunology project, exhibits strategic identification of educational gaps and elevates team acumen.
Consistently demonstrates strong scientific acumen.
* Actively participate in team calls, trainings, & journal clubs through scientific dialogue, understanding of current standard of care, and regularly sharing of scientific news.
* Attends and provides leadership at scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community.
* Medical insights: Actively listens for, documents, and shares medical insights. Proactively synthesize data and medical insights for MSL team and other partners
* Sets aside time for self-driven learnings on current scientific landscape.
* Role includes representing and supporting JNJ at relevant scientific or other key stakeholder meetings including congresses, symposia, advisory boards and investigator meetings.
* Role includes representing JNJ at speaking engagements at relevant scientific or other key stakeholder meetings.
Continuous support Department Operations and Internal Partners:
* Performs all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities)
* Maintain focus and composure in uncertain circumstances with minimal direction.
* Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development
* Communicates and collaborates with all field-based partners, and other Immunology MSL teams on a routine basis.
* Demonstrate the ability to partner with others to lead or participate in large scale projects.
* Maintains thorough understanding and competence in the following areas (regulatory and health care compliance guidelines; corporate policies on appropriate business conduct and ethical behavior; Medical Affairs SOPs and guidelines.
Qualifications
Required:
A PharmD, PhD, MD, w/ 3+ years relevant hematology, immunology and/or auto/alloimmune disease experience
Minimum 3 years MSL experience, and/or 2-3 years relevant work exp (clinical or research experience)
Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies.
Ability to travel up to 70 %.
Preferred:
Launch experience in rare disease is highly preferred.
Significant experience giving presentations is highly preferred.
Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource.
#LI-Remote
Required Skills:
Preferred Skills:
Analytics Dashboards, Clinical Research and Regulations, Clinical Trials, Consulting, Customer Centricity, Data-Driven Decision Making, Digital Culture, Digital Literacy, Medical Affairs, Medical Communications, Medical Compliance, Mentorship, Product Knowledge, Relationship Building, Research and Development, Strategic Thinking, Tactical Planning, Technical Credibility
$90k-126k yearly est. Auto-Apply 7d ago
Cloud Platform Engineering Architect (AWS)
Gilead Sciences 4.5
Gilead Sciences job in Raleigh, NC
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
The Gilead Cloud Platform Engineering (CPE) Architect role will provide architectural leadership to the CPE DevOps Team on both delivery and support.
Description of Responsibilities
Gilead Cloud core platform services and automation development (design, development and delivery of technical code) for the AWS Control Tower Landing Zone
Terraform development impacting AWS account baselines, CI/CD integration with the platform, DMZ networking, and SCP management
Core platform and automation security hardening
Maintenance and support of core platform automation, guardrails and Security Control Policies (SCPs).
Platform development, coding, automation, role-based access control, authentication, Cyber Security hardening and cloud support
Continuous Integration/Continuous Delivery (CI/CD): Design, build, and maintain CI/CD DevSecOps pipelines to automate the building, testing, and deployment of applications. This includes Integration of CI/CD pipelines via automation with other services including security scanning, artifact repositories, ITSM, etc.
Infrastructure as Code (IaC): Manage and provision cloud infrastructure using tools such as Terraform to ensure consistent and repeatable deployments.
Cloud infrastructure management: Deploy, manage, and optimize cloud-based resources on platforms like AWS and Microsoft Azure.
Containerization and orchestration: Work with container technologies like Docker and orchestration systems like Kubernetes to manage and scale applications.
Monitoring and logging: Implement monitoring, logging, and alerting solutions to track application performance, system health, and security issues.
Security and compliance: Ensure that cloud environments and deployment practices adhere to security best practices and compliance standards.
Collaboration: Work closely with application teams, security, and quality assurance to troubleshoot issues and streamline processes.
Automation: Identify and automate manual and repetitive processes to increase efficiency and reduce human error. Leverage AI tools for improved automation and scale.
Troubleshooting: Perform root cause analysis and provide technical support to resolve issues in development, testing, and production environments.
Provide daily technical leadership and guidance to the Cloud Platform Engineering Core and CI/CD Engineering Scrum Team
Education and Experience Required:
Minimum Required Education and Years of Experience:
High School Degree and Fourteen Year's Experience
OR
Associates Degree and Twelve Years Experience
OR
Bachelor's Degree and Ten Years' Experience
OR
Masters' Degree and Eight Years' Experience
Public Cloud Services knowledge of AWS, MS Azure (a plus)
Development (coding) skills required, Terraform and GitHub expertise required
CI/CD DevSecOps opinioned pipelines subject matter expertise
Professional certifications a plus (Public Cloud, Architecture, Program Management etc.)
Agile/Scrum knowledge and leadership skills
Knowledge and Skills Required:
Subject matter expert on AWS, MS Azure Public Cloud services
Deep knowledge in Public Cloud Infrastructure and Application Architectures
Knowledgeable in all facets of compute, network and storage as it relates to Public Cloud Application Architecture
Subject matter expert in AWS Cloud Control Tower Landing Zone (CTLZ) architecture
Advanced knowledge of CI/CD DevSecOps opinioned pipelines and GitHub self-hosted runner architecture
Advanced code writing in multiple languages to design and deliver Gilead Cloud CI/CD pipeline services (primarily AWS, Azure a plus)
Code development in multiple languages preferred, expert skills in
Terraform and GitHub required
Understanding and capability to Lead an Agile Scrum Team
Strong root cause analysis skills to troubleshoot and resolve support escalations for Gilead Cloud core services
Develop and publish infrastructure and Application architecture designs
ITSM subject matter expertise to assist with implementation, integration, governance and improvement
Reporting and Analytics tools and development
Program Management skills - set up meetings, facilitate, assign actions, track/ follow up and report out
Proficient with Atlassian (Confluence and Jira), MS DevOps, MS Office, especially Outlook, Excel and PowerPoint. Use of large/complex Excel files will be required. GitHub expertise a must.
Advanced written and verbal communication skills
Specific job duties may vary and will flex to align with business requirements.
The salary range for this position is:
Raleigh: $168,980.00 - $218,680.00.
Bay Area: $195,670.00 - $253,220.00.
Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
******************************************************************
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
$80k-103k yearly est. Auto-Apply 56d ago
Senior Engineer, Process Development (Downstream)
Amgen 4.8
Holly Springs, NC job
Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.
Senior Engineer, Process Development (Downstream)
What you will do
Let's do this. Let's change the world. In this vital role you will advance Amgen latest bioprocessing platform and technology, delivering high quality of medicine to patients around the world.
The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgen's FleX Batch facility, focusing on technology transfer, process support, and optimization. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.
Responsibilities include but are not limited to:
Support technology transfer, process validation, and plant start-up
Provide technical leadership in Downstream (Purification) Bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management
Partner with cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives
Provide on-the-floor process support as required
Ensure safety and compliance of process development activities
Collaborate with other site-functions and network drug substance teams in delivering plant goals
Support regulatory filing, inspection, and other CMC activities
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team-player with these qualifications.
Basic Qualifications:
High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR
Associate's degree and 8 years of biologics process development or commercial-scale technical support experience OR
Bachelor's degree and 4 years of biologics process development or commercial-scale technical support experience OR
Master's degree and 2 years of biologics process development or commercial-scale technical support experience OR
Doctorate degree
Preferred Qualifications:
Master's degree in Engineering or Science discipline
5+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP)
In-depth expertise in biologics process purification processes
Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation
Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders
Able to apply engineering principles and statistical analysis in resolving complex issues
Knowledge in regulatory filings and inspections
Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes
Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use)
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
119,195.00 USD - 147,867.00 USD
$88k-108k yearly est. Auto-Apply 60d+ ago
Manufacturing Procurement Site Lead
Amgen 4.8
Holly Springs, NC job
**Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Manufacturing Procurement Site Lead
**What you will do**
Let's do this. Let's change the world. We are seeking an individual who thrives in ambiguity and is capable of driving procurement outcomes in a manufacturing operations environment with strategic vision and precision. In this vital role you will oversee the operations and management of manufacturing procurement at one of Amgen's world class global manufacturing sites. This position will play a key role in ensuring procurement deliverables support effective and efficient site-based manufacturing activities, while maintaining compliance with regulatory requirements, and driving continuous improvement in manufacturing operations. Reporting to the Manufacturing Site Lead within Internal & External Manufacturing, you will also act as the lead procurement business partner for the Site Head and their functional and cross-functional leadership team, connecting procurement outcomes to strategic business objectives at the site.
**Roles & Responsibilities:**
+ Drive continuous improvement Procurement initiatives by identifying inefficiencies, recommending solutions, and implementing changes to enhance manufacturing performance, speed, and delivery.
+ Champion a multi-year pipeline of savings and value plans across the manufacturing site that alignment with category and business strategies delivered against Finance's annual budget plan
+ Be a trusted advisor across the Site Leadership Executive teams - ability to grow and maintain influence of Sourcing Agenda and delivered through strategic business partnership
+ Be a Procurement leader with strong financial competence, experienced with accountability to site Executives and cross-functional leaders
+ Lead with a commitment to continuous improvement in sourcing processes, tools and operating model; Develop goals and prioritize impact to site work among multiple initiatives; Courage to provide performance feedback across the category and sourcing teams
+ Connect the dots and translate central functional programs into site based deliverables and outcomes
+ Champion supplier relationship management for critical suppliers at the site level
+ Identify and mitigate supply risk while ensuring Procurement deliverables adhere to regulatory requirements (e.g., GLP, GMP, ISO) and implement quality control systems, including audits, inspections, and compliance-related activities.
+ Monitor and report on Procurement performance metrics, making necessary adjustments to meet organizational goals and identifying opportunities for cost savings and process improvements.
+ Evaluate and implement, through Procurement, process improvement, environmental sustainability, and automation initiatives to enhance operational efficiency and support long-term goals.
+ Maintain up-to-date knowledge of industry standards and best practices, sharing innovative procurement solutions within the global manufacturing operations network.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.
**Basic Qualifications:**
Doctorate degree and 2 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Or**
Master's degree and 4 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Or**
Bachelor's degree and 6 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Or**
Associate's degree and 10 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Or**
High school diploma / GED and 12 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience
**Preferred Qualifications:**
+ In-depth knowledge of procurement best practices across manufacturing, capital, equipment, and technologies.
+ Familiarity with industry standards and regulations (e.g., GLP, GMP, ISO, OSHA).
+ Proven track record to drive value in a procurement environment supporting manufacturing
+ Strong analytical skills to monitor performance metrics, optimize procurement deliverables, and ensure compliance.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $145,239 to $170,803. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
**Apply now and make a lasting impact with the Amgen team.**
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
**Application deadline**
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
**Sponsorship**
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.