Senior Specialist, Medical Writing
Edwards Lifesciences job in Raleigh, NC
Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
**How you will make an impact:**
+ As a key member of the Clinical Science team, the Sr. Specialist, Clinical Science/Medical Writing is responsible for supporting the development of regulatory and clinical documents for a dynamic portfolio of products across TMTT.
+ Perform and maintain systematic literature searches, developing search terms and criteria, extracting relevant clinical data, and writing clear and concise summaries of the data to support the development of clinical evaluation reports and clinical study reports
+ Develop routine, sustaining medical writing documents/deliverables; propose approaches to developing moderately complex documents/deliverables
+ Review and provide thoughtful feedback on moderately complex cross-functional deliverables (e.g., clinical study data, risk management documents, IFUs, SSED) using clinical and technical knowledge
+ Serve as the primary contact, negotiating deliverables, timelines, and resolving project-related issues with assistance, in collaboration with cross-functional stakeholders
+ Assist in the implementation of continuous process improvements as it relates to medical writing
+ Other incidental duties
**What you'll need (required):**
+ Bachelor's Degree in a related field with 5 years of related experience working in medical affairs, clinical affairs and/or clinical science
**What else we look for (preferred):**
+ Preferred Hybrid On Site in Irvine, Ca
+ Advanced degree (Master's, PHD, Pharm D)
+ Experienced with literature reviews and various publication databases including PubMed and Embase.
+ Familiarity with the cardiovascular therapeutic area-including, but not limited to, structural heart interventions, coronary interventions, heart failure-and current treatment landscape; familiarity with clinical research and/or clinical trial experience.
+ Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations.
+ Familiarity with FDA PMA applications.
+ Good knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations.
+ Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, physicians, statisticians, and support personnel.
+ This position can be an onsite role based at Edwards Lifesciences' corporate headquarters in Irvine, California.
**Additional skills and general expectations:**
+ Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously
+ Excellent oral and written communication skills
+ Experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge
+ Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat
+ Strong analytical, problem-solving, and scientific writing skills
+ Strict attention to detail
+ Ability to interact professionally with all organizational levels
+ Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects
+ Ability to build productive internal/external working relationships
+ The Sr. Specialist will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA), the base pay range for this position is $106,000 to $149,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.
\#LI-Remote
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**COVID Vaccination Requirement**
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Director, Field Health Economics and Reimbursement
Edwards Lifesciences job in Raleigh, NC
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Director, Global Health Economics and Reimbursement is a field-based role responsible for working directly with hospital executives, cardiovascular service line leaders and physicians to ensure they recognize the economic and clinical value of the transcatheter heart valve (THV) therapy. They will work directly with hospital leaders and physicians to deliver hospital economic analyses customized to each provider. This individual will also support the health care providers in obtaining optimal reimbursement (payment rates and market access) by serving as a knowledgeable resource in coding, coverage and payment, as well as, an intermediary to payers including Center for Medicare Services (CMS) and/or Medicare Administrative Contractors (MAC), Medicaid, Veteran Affairs (VA) and commercial payers.
**The Director, Global Health Economics and Reimbursement will reside in either Florida, South Carolina, or North Carolina and support field activity in those markets.** The role will report to the Sr. Director East, Global Health Economics and Reimbursement.
**How you'll make an impact:**
+ Ensure THV value messages are consistently developed and delivered, and customer feedback on value proposition is communicated to internal THV leadership. This will necessitate a competence in developing, synthesizing, and presenting health economic analytics.
+ Establish and maintain effective working relationships with key stakeholders at hospitals engaged in THV procedures, including hospital executives, cardiovascular administrators, quality, finance, documentation integrity, billing, and physicians (interventionists and surgeons), to support the site in establishing and maintaining a THV program through the development and implementation of reimbursement plans (coding, coverage, payment) unique to each provider.
+ Articulate a thorough understanding of the structural heart landscape, trends, and market insights. A strong understanding of the commercial and government payor landscape including coverage policies and payment processes. This will include managing and addressing coverage policy issues with payors, as necessary.
+ Understand health economic and quality content: billing, coding, payment, coverage, policy, hospital finances, structural heart program innerworkings, cath lab and OR processes, clinic, and procedural expertise, etc.
+ Identify needed additional expertise and quickly assimilate information and communicate trends, clinical research, policies, etc. and how they will impact TAVR/Structural Heart business. Identifies market trends and customer needs and supports development of strategies and resources for their customers and team.
+ Manage demands and needs of multiple programs and customers. Provide high touch program support and build access to key leaders within each organization.
+ Build a strategic relationship and serve as a supporting role to our aligned business partners including sales, marketing, government affairs, and medical/clinical affairs.
+ Assist our Regional and Territory Sales Managers in the development, implementation, and management of strategic initiatives within geography.
+ Perform other duties and responsibilities as assigned.
**What you'll need (Required):**
+ Bachelor's Degree or equivalent in a life science, health economics, health policy, or related field plus 12 years of experience in health policy, health economics, medical device reimbursement and technology assessment or master's degree plus 10+ years of related experience, or equivalent work experience based on Edwards criteria.
+ Basic understanding of medical and clinical research methodologies, including the ability to interpret scientific publications and apply evidence to support product value propositions.
+ Demonstrated business acumen and analytical thinking, with experience collaborating cross-functionally with teams such as Sales, Marketing, Clinical, Regulatory, Legal, and Government Affairs to address economic and reimbursement considerations.
+ Foundational knowledge of health economics and reimbursement, including familiarity with billing, coding, payment systems, coverage policies, and hospital financial operations related to structural heart programs and procedures.
+ Ability to travel up to 50% domestically
**What else we look for (Preferred):**
+ Minimum of 5 years of work experience in a field based, consultative, or administrative role within the healthcare industry.
+ Reimbursement and/or sales experience.
+ Strong understanding of the commercial insurance landscape and relevant reimbursement processes. A solid understanding of public payer programs, e.g., CMS, including coverage, coding, and payment policies.
+ Ability to build and maintain strong relationships with hospital leaders and physician customers.
+ Proficient in Microsoft Office Suite (i.e., Excel, PowerPoint, Word, Outlook).
+ Excellent interpersonal skills, written and verbal communication skills, especially presentation development and delivery in person and virtually. Must be confident, articulate and have professional speaking abilities.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
**COVID Vaccination Requirement**
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
Patient Benefit Representative
Cary, NC job
Patient Benefit Representative (Onsite)
Pay Rate: $25.00 - $35.00/hour
Schedule: Monday - Friday, 9:00 AM - 6:00 PM
About the Role
We're looking for a Patient Benefit Representative to join our team! In this role, you'll support patients by providing telephonic counseling, nursing intervention, and reimbursement assistance. You'll work closely with physicians, healthcare professionals, and a multidisciplinary team to ensure patients receive the guidance and support they need throughout their treatment journey.
This position blends compassionate patient interaction with strong organizational and healthcare benefits knowledge - ideal for someone who enjoys making a difference every day.
What You'll Do
Provide telephonic patient counseling and support related to treatment programs.
Coordinate reimbursement and benefit verification services.
Collaborate with physicians, nurses, and other healthcare professionals.
Maintain accurate patient documentation and follow established procedures.
Use web-based systems, phone, and occasional in-person communication to assist patients.
What We're Looking For
Experience in healthcare benefits, patient services, or medical reimbursement.
Strong communication and problem-solving skills.
Ability to work independently with moderate supervision.
Knowledge of healthcare policies and procedures.
Detail-oriented and empathetic approach to patient care.
Education & Experience
High school diploma or equivalent required; associate or bachelor's degree preferred.
Previous experience in a healthcare, medical billing, or patient support role strongly preferred.
Senior Production Scheduler, CVRM (Holly Springs)
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.
Manufacturing Specialist - Single Use Systems (SUS)
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.
Manufacturing Specialist - Single Use Systems (SUS)
What you will do
Let's do this. Let's change the world. In this vital role you will be part of the Manufacturing Support team which is responsible for manufacturing activities such as new product introduction, new technology and equipment introduction, continuous improvement projects, supporting CAPA ownership, deviation trending, and optimization/implementation of single use technologies. The position is within the drug substance organization in Amgen North Carolina at Holly Springs. This role is critical for Amgen North Carolina's success and key in supporting single-use (SUS) operations.
Support New Product introduction and projects through SUS mapping/drawing.
Maintain and edit SUS Standard Operating Procedures (SOP).
Support manufacturing and quality through the SUS defect/leak triage process - perform troubleshooting on the floor, initiate investigations and bring leaks and defects to triage meetings.
Initiate Event Notification (EN)/Supplier Investigation/Corrective Action (SICAR) records and follow process to conclusion, including collaborating with vendors on investigation.
Maintain up-to-date EN/SICAR/Early Engagement (EE=new item) trackers and manage or lead small to medium projects.
Provide input for ANC representative to SUS network for improvements and troubleshooting.
Support Vendor Change Notification assessments.
Understand single-use material capabilities and user requirements for new technologies through interaction with end users.
Collaborate with Continuous Improvement (CI) leads to help SUS improvement projects and provide/lead use cases for continuous improvement projects. For example, improvements around tubing management, material kitting and flow.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. We are looking for a detail-oriented partner with an understanding of manufacturing operations and a passion for single-use systems, with the following qualifications.
Basic Qualifications:
High School/GED and 4 years of manufacturing or operations work experience OR
Associate's Degree and 2 years of manufacturing or operations work experience OR
Bachelor's Degree and 6 months of manufacturing or operations work experience OR
Master's Degree
Preferred Qualifications:
Experience with and understanding of Single-Use Systems.
Experience in Drug substance GMP technical support roles, GMP manufacturing, Engineering, Process Development, or equivalent.
Technical knowledge of drug substance processing and broad understanding of related disciplinary areas.
Ability to successfully 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 area.
Team player - Ability to support process owner team by reprioritizing or readjusting projects, tasks, or responsibilities.
Ability to drive results through leadership of cross-functional teams.
Data analysis and/or data visualization skills
Excellent writing skills. Presentation experience - presentation to leadership.
Determines work tasks and timelines self-sufficiently - ability to navigate through ambiguity and prioritize effectively
Proficiency in computerized systems for example, Smartsheet, excel, Trackwise, Veeva, Visio.
Expertise with translating business/user needs to user requirements and recommend solutions.
Experience in individually supporting key manufacturing systems with 24x7 operations.
The ability/experience of working in fast paced manufacturing environment where issues must be assessed, understood, and resolved immediately to be able to adapt quickly to the demands of commercial manufacturing operations.
Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, and quality.
Pro-active, result oriented, and ability to prioritize work to meet timelines.
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
88,378.00 USD - 106,188.00 USD
Auto-ApplyManufacturing Procurement Site Lead
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.
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Salary Range
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Auto-ApplyClinical Case Educator - Oncology/Specialty
Cary, NC job
McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care.
What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.
Job Summary
A Clinical Case Educator requires the credentials of a Registered Nurse. In this role, a registered nurse is passionate and is committed to provide a high level of patient care and counseling patients enrolled in the Medication Therapy Program. The ideal candidate has great communication skills, problem solving skills, and must be self-motivated. This person will be driven to help team members to achieve the mission of providing high level of care to patients. This position is a telehealth position. The nurse will report adverse events and provide clinical interventions to the patient based on assessed need.
Shift Information: Starting 3/1/2026 Nurses will be onsite twice a week.
Cary, NC - Monday-Friday from 9am-6pm The nurses are required to report to the office twice a month for training and special meetings.
Fort Worth, TX - Monday-Friday from 8am-5pm CST. The nurses are required to report to the office twice a month for training and special meetings.
One rotating Saturday per quarter.
PTO Blackout Dates - around Thanksgiving, Christmas, and New Years holidays.
The target budget for this role is at $40/hour, plus 5% annual bonus.
Key Responsibilities:
Counsel and educate new/existing patients on specialty drug therapies.
Adherence to contracted and accrediting regulations as indicated by drug specification.
Complete, thorough, and accurate documentation utilizing good documentation practice and compliance to industry standards and regulations.
Discuss potential/current side effects with patients to educate about treatment alternatives and facilitate ongoing therapy adherence.
Identify and report adverse events (AEs) and product complaints (PCs) to the manufacturer, FDA, and/or other governing authorities.
Specialty drug verification and education. Provider/patient conduit to support therapeutic longevity.
Adherence to patient management programs through call cadence schedules, medication management programing, drug counseling and provider collaboration.
Maintenance of patient demographic records, medical history, and records in accordance with federal HIPAA standards.
Collaboration with Pharmacy Support teams to ensure timely and accurate delivery of specialty drugs.
Minimum Requirements:
Degree or equivalent and typically requires 4+ of relevant experience or a combination of education and experience.
Active RN license in NC/TX
Critical Skills:
4+ years of nursing experience with at least 1 year of acute.
Experience in Oncology or other specialties.
Registered Nurse with current unrestricted compact state license or primary NC licensure. TX RN license is required for residents of TX
Ability to obtain licensing in all states and United States territories serviced within 3 months of employment through Biologics supported programming (minimal application guidelines apply)
Computer skills, including e-mail, word processing, spreadsheet and web-based programs
Effective orally and in writing communication, experience with motivational interviewing preferably
Ability to read, analyze and interpret practice standards, professional journals, technical procedures and government standards and regulations
PTO Blackout Dates - around Thanksgiving, Christmas, and New Years holidays.
Education:
Associates, Bachelor or higher degree in Nursing or accredited nursing diploma
Physical Requirements:
Large percent of time performing computer-based work is required
Hybrid position-Office days required. Starting 3/1/2026 Nurses will be working onsite twice a week.
We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.
McKesson is an Equal Opportunity Employer
McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.
Join us at McKesson!
Auto-ApplyIntern - IT - Enterprise Data & Analytics
Raleigh, NC job
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
As a Gilead intern you will contribute to high-impact meaningful projects that will not only further advance our company's mission but will allow you to gain real world experience at one of the most innovative organizations in the world. You will also have opportunities to participate in special events including professional development and leadership presentations, social/network building activities and local community volunteer programs.
Key Responsibilities will include, but are not limited to the following:
Learning Objectives: US Commercial Data, AWS and Databricks data pipelines, Gilead culture
Data & Analytics DevOps: Assist the team in adhoc DevOps manager tasks
GenAI: Lead Innovation POCs with GenAI-first approach to improve team operations and end-user experience
Strategy & Roadmap: Influence cross-functional partners like the Platform team to streamline team's technical Roadmap intake and monitor its execution
Team support: Assist the team in broader communication activities like newsletters, QBRs and team events organization
Showcase your work with a final presentation (PPT) near the conclusion of your internship
Required Qualifications:
Must be at least 18 years old
Must have a minimum GPA of 2.8
Authorized to work in the United States without Sponsorship now or in the future or CPT/OPT through your University.
Must be currently enrolled as a full-time student in a Bachelor's/Masters/MBA/PhD program at an accredited US based university or college
Must be a Rising Sophomore, Junior, or Senior in undergrad or a Graduate or Doctoral Student
Must be enrolled full-time in the Fall Semester at an accredited university/college after the completion of the internship
Must be able to complete a 10-12 consecutive week internship between May and August
Must be able to relocate if necessary and work at the designated site for the duration of the internship
Preferred Qualifications:
Preferred Degree qualification: BA/BS
Proficiency with MS Office Suite
Ability to identify issues and seek solutions
Ability to work both independently and collaboratively
Demonstrated commitment to inclusion and diversity in the workplace
Efficient, organized, and able to handle short timelines in a fast-paced environment
Gilead Core Values:
Integrity (Doing What's Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal Responsibility)
The expected hourly range for this position is $19.00 - $55.00.
Gilead considers a variety of factors when determining base compensation, including education level and geographic location. These considerations mean actual compensation will vary.
Benefits include paid company holidays, sick time, and housing stipends for eligible employees.
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.
Auto-ApplySenior Maintenance Technician - Utilities, Lead
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.
Senior Maintenance Technician - Utilities, Lead
What you will do
Let's do this. Let's change the world. In this valuable role you will provide technical expertise and guidance supporting the start-up of the utilities and daily operations. This position is scheduled Monday through Friday (7am to 4pm), with rotating on call.
Perform intermediate installation, troubleshooting, maintenance, repair, testing and documentation/logs of utility and process equipment.
Perform operations, maintenance and repair activities on utility equipment and systems providing utilities serving Manufacturing, Lab, and various operations across the ANC site:
Specific Manufacturing and Lab utility systems include: clean steam, water for injection (WFI), process cooling water, process air, process gases, process waste, HVAC systems, walk-in cold rooms and freezers, and other environmental control units (chambers).
Specific plant systems include: steam, chilled water, compressed air, cooling tower water, and heating hot water.
Maintenance activities include: inspections, testing, minor/major equipment overhauls, pump rebuild/replacements, valve rebuild/replacements, HVAC troubleshooting/repair, piping modification/repair, etc.
Additional responsibilities include partnering with maintenance service providers and equipment vendors.
Management of work orders for craft, including scheduling of work orders. Ensuring work orders are assigned and completed on time.
Complete quality and safety documentation and completion of work in a safe, compliant, and timely manner according to planning and predefined schedules with minimal impact to production while aligning with GMPs, SOPs and Amgen policies and regulations.
Work in a highly productive and efficient manner to maximize the quantity of activities completed with focus on maintenance excellence.
Ensure work is appropriately communicated to system operators and key stakeholders.
Ensure work order documentation is completed accurately.
Review maintenance reports, forms, plans and records.
Identify waste, work-flow interrupters, and other opportunities for improvement, recommend solutions, and assist with implementation.
Identify opportunities to learn new skills and actively participate in development that will improve overall team performance.
Represent the Utilities Maintenance team in discussions and meetings with management and peers.
Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights, weekends and holidays.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Maintenance teammate we seek is a dynamic candidate with these qualifications.
Basic Qualifications:
High School Diploma / GED and 6 years of Utility Operations or Maintenance experience OR
Associate's Degree and 4 years of Utility Operations or Maintenance experience
Preferred Qualifications:
7+ years knowledge of utility operations and mechanical maintenance with an emphasis on plant utility equipment and systems (chillers, boilers, cooling towers, air compressors, etc.) and ability to effectively perform associated maintenance activities.
5+ years knowledge of pneumatic, mechanical, and hydraulic systems and ability to effectively perform associated maintenance activities.
Knowledge and experience within a cGMP or other highly regulated environment.
Experience executing and documenting maintenance work orders in a computerized maintenance management system.
Ability to interpret P&ID's.
Ability to work with minimum direction.
Ability to effectively communicate issues and status of tasks in a timely manner.
Ability to interact constructively with peers/teams.
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
-
Auto-ApplyProcess Development Associate (Attribute Sciences)
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.
Process Development Associate (Attribute Sciences)
What you will do
Let's do this. Let's change the world. This role is part of Amgen's Attribute Sciences (AS) department within the Process Development (PD) organization that defines the favorable quality characteristics of the therapies it produces and optimizes innovative analytical tools to guide that development.
In this vital role, you will work to provide scientific and technical contributions within Process Development Attribute Sciences at Amgen's FleX Batch facility. This laboratory-based role will evaluate attributes of materials based upon multiple analytical techniques, focusing on analytical testing, support, and troubleshooting.
Responsibilities include effectively delivering to the site, process development team, and quality control through rapid and robust analytical testing.
Ensure analysis support for small-scale model transfer, method transfers, investigation support, and continuous improvements
Work closely with functions including but not limited to Drug Substance, Quality, and Manufacturing
Understand analytical methodologies to detect product quality attributes and process-related impurities' testing using a variety of techniques including but not limited to UV-Vis spectroscopy, chromatography, capillary electrophoresis, and PCR.
Execute methods, author reports and ensure safety and compliance for all activities.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
High school diploma / GED and 4 years of Process Development / Chemistry or related experience OR
Associate's degree and 2 years of Process Development / Chemistry or related experience OR
Bachelor's degree
Preferred Qualifications:
Degree in Chemistry or related area.
Experience in pharmaceutical process development with related experience in analytical support, execution of methods, and investigational testing.
Experience in single or multiple analytical techniques (i.e., CE (Capillary Electrophoresis), ELISA, DNA, Chromatography (SE and RP), PCR).
Experience in method transfers, method validation, and method troubleshooting.
Familiarity with United States Pharmacopeia (USP) monographs and chapters, and International Conference on Harmonization (ICH) / Food & Drug Administration (FDA) mentorship documents related to analytical method transfer and validation.
Effective oral and verbal communication skills.
Technical writing skills and attention to details in documents.
A self-starter and valuable teammate.
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
79,971.00 USD - 89,221.00 USD
Auto-ApplyManager Manufacturing, Single Use Systems & Validation
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.
Manager Manufacturing, Single Use Systems & Validation
What you will do
Let's do this. Let's change the world. In this vital role you will act as the Manager for the Single Use Systems and Cleaning Validation Team in our GMP Drug Substance Manufacturing facility. This position is within Amgen North Carolina (ANC) Drug Substance FlexBatch Manufacturing facility in the- Manufacturing Support organization.
ANC is a dynamic environment and an important supply facility for Amgen's pipeline products. The GMP FlexBatch plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. In this vital role, you will act as the Manager for Single Use Systems and Cleaning Validation, leading a team responsible for the oversight, implementation, and continuous improvement of single use technologies and equipment cleaning validation strategies in GMP manufacturing. You will be a key technical and communication interface between manufacturing operations, process development, engineering, supply chain, and quality.
Provide technical leadership and subject matter expertise for Single Use Systems and equipment cleaning validation activities in the manufacturing area.
Oversee development, implementation, and maintenance of SOPs, training materials, and Quality Management System records related to Single Use Systems and equipment cleaning validation.
Lead development and execution of the site's Cleaning Validation Master Plan (CIP/SIP/COP for equipment and controlled temperature chambers), validation plans, equipment qualification protocols/reports, and cleaning validation strategies.
Manage and mentor a team of specialists and engineers, including hiring, training, performance evaluations, and development.
Coordinate troubleshooting and support during commissioning, qualification, start-up, and process performance qualification of the facility.
Facilitate process, area, and equipment risk assessments to identify risks, failure modes, and mitigating actions.
Ensure compliance with regulatory requirements, support regulatory submissions, audits, and inspections.
Champion Lean Transformation and operational excellence initiatives, driving continuous improvement in the plant.
Collaborate cross-functionally with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure alignment and readiness for new products, process changes, and advanced technologies.
Develop and implement training plans and programs to ensure staff are prepared and compliant.
Maintain inspection readiness and support staff with audit or regulatory response strategy.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.
Basic Qualifications:
High school diploma/GED and 12 years of biotechnology operations or validation experience OR
Associate's degree and 10 years of biotechnology operations or validation experience OR
Bachelor's degree and 5 years of biotechnology operations or validation experience OR
Master's degree and 3 years of biotechnology operations or validation experience OR
Doctorate degree
Preferred Qualifications:
Educational background in Chemical Engineering, Industrial Engineering, Biology, Biochemistry, Life Sciences, or related field.
Experience leading/managing a team of direct reports in a GMP manufacturing environment.
Strong technical knowledge of Single Use Systems and Cleaning Validation strategies for biologics manufacturing.
Experience in supporting regulatory submissions, audits, and inspections.
Proficient technical writing and presentation skills to communicate complex information effectively with technical and senior management staff.
Experience in cross-functional project management and operational excellence initiatives.
Ability to coach, mentor, and cross-train colleagues within core technical areas.
Background in lean manufacturing methodologies and continuous improvement.
Knowledge of relevant regulations (e.g., FDA Title 21 CFR Part 210/211, Eudralex Annex 15, ASTM E2500, ICH Q7).
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
114,259.00 USD - 133,764.00 USD
Auto-ApplySpecialist Manufacturing: NPI, Process Owner
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
Auto-ApplyIS Network Architect
Holly Springs, NC job
Career CategoryInformation SystemsJob 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.
IS Network Architect
What you will do
Let's do this. Let's change the world. In this vital role you will be accountable for developing and continuously aligning the site manufacturing data ecosystem with rapidly changing business needs and Amgen IS technical roadmaps. They will support complex and exciting IS initiatives that require understanding of analytical problem-solving techniques, project management, lifecycle management and Operational Excellence.
This role is required to possess strong domain expertise in Manufacturing Information/Data Management and technical experience in database and data historian technologies and integration tools. This candidate is expected be proficient and enthusiastic in the areas of Industry 4.0 / Smart Manufacturing and leveraging data and digital technologies to transform manufacturing operations.
Key job responsibilities:
To be successful in this role, you will need to:
Developing and continuously align the site manufacturing system ecosystem with rapidly changing business needs and Amgen technical roadmaps
Collaborate with business partners and other architects to develop a vision and multi-year roadmap for the advancement and lifecycle management of the applications.
Collaborate with the service owners, support teams and the application run management to maintain and support the systems.
Manage and/or support the execution of a varied portfolio of Manufacturing Systems projects with appropriate portfolio planning, resource and risk management and financial management for the portfolio.
Shaping Amgen's future - Keep track of industry and technology trends, connect and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry.
Performs cross system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solution. Manage multiple initiatives and priorities
Effectively manage relationships with IS service owners, business partners, enterprise IS service partners, and vendors
Communicates with multiple levels within the organization, highlighting issues and proposing solutions.
Elicit and analyze needs identified by business stakeholders and convert them into functional design.
Accountable for deployment and integration design across multiple applications to be implemented at the site.
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 designing, developing, deploying, and operating Manufacturing Information and Data Systems experience
Or
Bachelor's degree and 4 years of designing, developing, deploying, and operating Manufacturing Information and Data Systems experience
Or
Associate's degree and 8 years of designing, developing, deploying, and operating Manufacturing Information and Data Systems experience
Or
High school diploma / GED and 10 years of designing, developing, deploying, and operating Manufacturing Information and Data Systems experience
Preferred Qualifications:
8+ years' experience in a manufacturing environment with 5+ years of demonstrated ability in the Pharmaceutical or Biotechnology industries
Strong knowledge of Cisco networks and enterprise architecture
CCNA or CCNP highly preferred
Strong experience in methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping)
Technical oversight of infrastructure engineering
5+ years' combined experience with the following product platforms: Data Historian and/or MES and/or Automation/Control Systems and/or laboratory systems and/or IS platforms
Familiarity with industry standards for software development life cycle methodologies and 21 CFR Part 11
Experience using Visio, Lucidchart etc. to generate architecture and data flow diagrams
Experience working with Agile development methodologies (such as Sprint and Scrum) and DevOps
Hands-on experience with computerized systems including troubleshooting, reliability and performance improvements
Effective verbal and written communication skills
Strong interpersonal skills with ability to work collaboratively in a team-based environment
Ability to lead multiple tasks and effectively set priorities
Strong computer skills and possess the ability to apply science-based thinking to practical applications
Energetic, innovative and technically-minded individual!
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
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.
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
119,506.00 USD - 150,235.00 USD
Auto-ApplyManager Manufacturing, New Product Introduction (NPI)
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.
Manager Manufacturing, New Product Introduction
What you will do
Let's do this. Let's change the world. In this vital role you will act as the Manager for the New Product Introduction (NPI) Team in GMP Drug Substance Supply. This position is within Amgen North Carolina (ANC) Manufacturing and GMP Supply - Manufacturing Support organization.
ANC is a dynamic environment and an important supply facility for Amgen's pipeline products. The GMP DSS plant manufactures drug substance for clinical trials and commercial supply through GMP production using both stainless steel and single-use equipment platforms. This NPI team is a key communication and technical interface between the GMP manufacturing operations teams in the plant and Process Development, Drug Substance Technologies & Engineering, Supply Chain, Facilities & Engineering, and Quality.
Directly manage a team of NPI leads responsible for introduction of new products and/or advanced technologies into the plant. Includes hiring, training, oversight, performance evaluations, and development.
Proactively assess the NPI team capabilities to meet the evolving drug substance supply needs (ex. resources, platform technical understanding, cross-functional alignment).
Lead team meetings and drive alignment in business processes across the team.
Coordinate with PD, DSTE, Supply Chain, Planning, Facilities and Engineering, Quality as well as Manufacturing for the introduction of new products, process changes and improvements and/or advanced technologies into the plant.
Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
Collaborate with Regulatory and Quality partners to ensure compliance of team change control records/documents and respond to regulatory questions and/or audit findings.
Drive a culture of inspection readiness across the team by ensuring NPI change controls are kept up to date and supporting staff with audit or regulatory response strategy.
Interacts with management in planning, developing, and maintaining budget
Assist in developing and maintaining department goals
Interact with regulatory agencies as needed
Responsible for engaging staff and building relationships of trust and respect while driving team performance and continuous improvement
Responsible for selection, training, evaluation, staff relations and staff development
Mentor and coach staff members to live by the Amgen Values
Develop and implement trainings plans and programs, to ensure staff are prepared and compliant
Other functional responsibilities may be assigned
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
High school diploma / GED and 12 years of Manufacturing or Operations experience OR
Associate's degree and 10 years of Manufacturing or Operations experience OR
Bachelor's degree and 5 years of Manufacturing or Operations experience OR
Master's degree and 3 years of Manufacturing or Operations experience OR
Doctorate degree
Preferred Qualifications:
Degree in Chemical Engineering, Industrial Engineering, Biology or Biochemistry
Experience leading/managing a team of direct reports
Experience with PAS X, Werum software
Experience in GMP operations, including New Product Introduction (NPI)
Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, buffer compounding) 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
Background in lean manufacturing methodologies and operational excellence
Experience in cross functional Project Management
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
114,259.00 USD - 133,764.00 USD
Auto-ApplySenior Manufacturing Systems Engineer: Automation - DeltaV
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 Manufacturing Systems Engineer: Automation - DeltaV
What you will do
Let's do this. Let's change the world. As a Senior Manufacturing Systems Engineer, you will provide automation technical leadership to a group of automation engineers who are responsible for building and maintaining various automation systems and platforms that support the GMP Drug Substance Plant Operations.
In this vital role as a member of the Facilities & Engineering (F&E) Automation team you will work hand in hand with the capital project team to deliver robust process automation systems to operate the new plant.
Site design, construction, start-up, and operational readiness
Collaborate with key stakeholders and end-users to understand and synthesize key process requirements, and to develop solutions using Amgen standard automation platform for process automation systems
Support design phases to ensure design aligns with Amgen specifications, incorporates the latest technology, and meets safety requirements
Support vendor FAT to ensure that control strategy and software code meet Amgen requirements
Develop and maintain engineering and maintenance documentation, and associated procedures for delivered solutions and processes
Collaborate with cross-functional teams to develop a robust commissioning and qualification plan and/or qualification strategy
Support commissioning and qualification including Automation Installation Verification/Automation Check Out (IV/ACO)
Support QA partners in performing computerized systems validation in a GxP environment
Perform Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
Site Operations
Own and drive to completion Change Controls, CAPAs, and Deviations
Lead and support technical root cause analysis, incident investigations, and troubleshooting
Lead and support functional area projects focused on improving process equipment, utilities, and facilities as well as large capital projects to integrate new drug substance manufacturing technologies into the facility
Drive continuous improvement for process automation systems to improve operational workflows, safety, reliability, efficiency, and sustainability
Support day-to-day operations including rotational on-call support
Perform and maintain Data Integrity Assessments (DIA) in accordance with the current Amgen and industry standards
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications:
Basic Qualifications:
High School diploma/GED and 10 years of engineering experience OR
Associate's degree and 8 years of engineering experience OR
Bachelor's degree and 4 years of engineering experience OR
Master's degree and 2 years of engineering experience OR
Doctorate degree
Preferred Qualifications:
Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or related field
Direct knowledge of automation system design
Experience in programming, installation and lifecycle management of automation and field instrumentation technologies
Experience in automation of GMP biopharmaceutical equipment and systems such as buffer prep and hold, chromatography, single use mixing vessels, depth filtration, and solution prep
Experience in integrating various OEM automation software
Experience in programming, design, installation and lifecycle management of manufacturing process controls, and automation and field instrumentation technologies.
Experience with Emerson DeltaV DCS system and ability to perform advanced troubleshooting, and system integration using OPC, Foundation Fieldbus, and Profibus technologies
Ability to interpret and apply GAMPs and GMPs, and familiarity with documentation in a highly regulated environment with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95
Self-directed team player able to work cross-functionally
Strong leadership, technical writing, and communication skills
Ability for domestic and international travel
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
142,955.00 USD - 162,947.00 USD
Auto-ApplyAssociate Maintenance Planner / Scheduler
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 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 Maintenance Planner / Scheduler
What you will do
Let's do this. Let's change the world. In this vital role you will be responsible for providing Plant Utility planning and scheduling support at the Amgen North Carolina site.
Work closely with System Owners to identify proper Job Plans.
Help to provide guidance on Maintenance Master Package completion based on Multisite SOP's, GDE's, STNDS, and other documents related to Work Order Administration.
Collaborate within Work Order Administration to ensure standardization of data loading into the Maximo CMMS System.
Provide hands-on training for System Owners while downloading and uploading data into appropriate data loaders.
Work closely with System Owners to assemble ASL's (Asset Spares List) for new equipment.
Work closely with System Owners to correctly identify and upload PM Next Due Dates.
Work closely with multiple disciplines, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
Support Project Implementation ensuring execution per schedule in accordance with project timelines.
Work independently 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.
Clearly communicate with Customers, F&E, Quality and Central Inventory staff regarding work order status and requirements.
Collaborate with customers and craft groups to schedule maintenance activities as required to support site operations.
Coordinate maintenance activities into efficient groupings to allow efficient execution by F&E crafts while minimizing the interruption to customer operations.
Identify and coordinate contractor resources as required to effectively complete tasks.
Work closely with WOA Team Lead Scheduler to ensure proper WOA Production/Finite scheduling.
Work closely with Utilities Scheduling lead to ensure proper Utilities Maintenance Scheduling.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
High school/GED + 2 years Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR
Associate's + 6 months Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience
Preferred Qualifications:
Proven experience in a mechanical or utilities related maintenance or maintenance support role or demonstrated ability in a maintenance engineering support role.
Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
Excellent written and verbal communication skills and the ability to work with minimal direction.
Excellent organizational skills, attention to detail, and ability to follow up.
Strong analytical problem-solving skills with a high degree of mechanical proficiency.
Broad skills and experience with maintenance and operations of plant utility systems and equipment.
Demonstrated ability to function within multi-functional teams and adopt a team-based culture.
Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services and GMP Utilities
Broad skills and experience with maintenance of utilities or process equipment.
Knowledge of work forecasting methods.
Ability to apply Microsoft Excel and various database querying tools.
Experience utilizing Maximo to manage maintenance programs.
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
72,791.00 USD - 87,312.00 USD
Auto-ApplyEngineering, Project Manager
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 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.
Engineering - Project Manager
What you will do
Let's do this. Let's change the world. This role is responsible for the strategic planning, implementation, and oversight of complex, high-impact facilities projects. The individual will ensure that all initiatives are completed on schedule, within budget, and in alignment with organizational standards for safety, quality, and operational excellence. The position requires strong leadership, technical expertise, and the ability to drive multi-functional collaboration to deliver projects that support Amgen's mission to change the world through innovation and excellence.
Lead and oversee the execution of multiple facilities engineering projects from initiation through completion, ensuring alignment with organizational goals and objectives.
Develop comprehensive project plans, including scope definition, timelines, budgets, and resource allocation strategies.
Coordinate and collaborate with internal stakeholders, external contractors, and consultants to ensure all project requirements, specifications, and deliverables are met.
Provide leadership and direction to multi-functional project teams, encouraging accountability, technical excellence, and effective communication.
Monitoring and evaluating project performance, identifying risks and implementing corrective actions to maintain schedule and budget adherence.
Ensure all projects align with applicable regulatory requirements, industry codes, and company standards for safety and quality.
Prepare, maintain, and present detailed project reports, status updates, and performance metrics to senior management and key collaborators.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The project management professional sought for this role will exemplify these values and possess the qualifications outlined below.
Basic Qualifications:
High school diploma / GED and 10 years of engineering project management experience OR
Associate's degree and 8 years of engineering project management experience OR
Bachelor's degree and 4 years of engineering project management experience OR
Master's degree and 2 years of engineering project management experience OR
Doctorate degree
Preferred Qualifications:
Demonstrated success in managing and delivering complex, large-scale projects within scope, schedule, and budget parameters.
Leadership and team management capabilities, with the ability to empower and guide cross-functional teams toward successful outcomes.
Exceptional communication, presentation, and interpersonal skills, with a focus on collaboration and stakeholder engagement.
Strong ability to perform effectively under pressure, manage challenging priorities, and meet tight deadlines.
Proficiency in project management methodologies, software, and analytical tools.
Project Management Professional (PMP) certification or equivalent credential preferred.
Prior experience within the pharmaceutical, biotechnology, or regulated life sciences industry strongly desired.
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
122,112.00 USD - 147,362.00 USD
Auto-ApplyElectrical Technician
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.
Electrical Technician
What you will do
Let's do this. Let's change the world. In this valuable role you will provide electrical technical expertise and guidance supporting the start-up of the plant utilities and daily operations.
Performing intermediate installation, troubleshooting, maintenance, repair, testing and documentation/logs of Electrical and utility equipment including Electrical power, lighting, solar array systems and components.
Performing intermediate installation, troubleshooting, maintenance, repair, testing and documentation/logs of Electrical and utility equipment including Electrical power, lighting, solar array systems and components.
Performing operations, maintenance and repair activities on electrical equipment and systems providing utilities serving Manufacturing, Lab, and various operations across the ANC site:
Specific electrical systems include: switchgear, MCC's, panelboards, lighting systems, UPS's, solar array inverters and emergency generators.
Specific control systems include: motor starters, VFD's, lighting systems, and misc. Low voltage circuits.
Electrical maintenance support activities include inspections, testing, minor/major equipment overhauls, pump rebuild/replacements, equipment troubleshooting/repair, etc.
Additional responsibilities include overseeing maintenance service providers and equipment vendors.
Completing quality and safety documentation and completing the work in a safe, compliant, and timely manner according to planning and predefined schedules with minimal impact to production while aligning with GMPs, SOPs and Amgen policies and regulations.
Work in a highly productive and efficient manner to maximize the quantity of activities completed with focus on maintenance excellence.
Ensure work is appropriately communicated to system operators and key stakeholders.
Ensure work order documentation is completed accurately.
Reviewing and technically approving maintenance reports, forms, plans and records.
Identify waste, work-flow interrupters, and other opportunities for improvement, recommend solutions, and assist with implementation.
Identify opportunities to learn new skills and actively participate in development that will improve overall team performance.
Represent the Utilities Maintenance team in discussions and meetings with management, peers and other site functions.
Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights, weekends and holidays.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Maintenance teammate we seek is a dynamic candidate with these qualifications.
Basic Qualifications:
High school diploma / GED and 2 years of Electrical Operations or Maintenance experience OR
2 years in a technical school setting with hands-on experience OR
Associate's degree and 2 years of Electrical Operations or Maintenance experience
Preferred Qualifications:
Experience in industrial/pharmaceutical electrical maintenance
4+ years of combined education, training, and experience in electrical operations and maintenance with an emphasis on facility and utility equipment and systems.
2+ years knowledge of electrical systems and ability to effectively perform associated operation and maintenance activities.
Working knowledge of local and national electric code requirements.
Knowledge and experience working in a highly regulated function - cGMP.
Experience executing and documenting maintenance work orders in a computerized maintenance management system.
Ability to interpret electrical schematics and drawings.
Ability to work with minimum direction.
Ability to effectively communicate issues and status of tasks in a timely manner.
Ability to interact constructively with peers/teams.
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
69,740.00 USD - 99,926.00 USD
Auto-ApplyManufacturing Procurement Site Lead
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.
Senior Engineer, Process Development (Downstream)
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
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