Edwards Lifesciences jobs in Raleigh, NC - 216 jobs

Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. 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. The Principal Biostatistician will represent the Biostatistics department on all aspects of the clinical development process, ranging from clinical trial designs to regulatory submissions while applying scientific rigor to statistical methods and interpretation of results and also advise on the conduct of clinical studies, database development and data quality assurance with the analysis of clinical endpoints in mind. **How you will make an impact:** + Statistical lead on one or more clinical trials, lead the coordination of analyses for study report and other documents and provide programming and validation support of these analyses + Collaborate with core stakeholders to provide statistical expertise in support of new product development (NPD) and/or regulatory submissions (e.g., PMA, CE Mark, PMDA) and other regulatory documents as needed + Represent Biostatistics on project/study teams and coordinate/communicate with management and other team members regarding project/study status and timeline update + Provide statistical expertise on ad hoc data analysis requests and publication/presentation efforts related to the project team + Compile technical documents for internal and external audits + Contribute to the improvement, standardization, and globalization of Biostatistics processes and procedures, including the development of Biostatistics Standard Operating Procedures (SOPs) and Work Instruction Manuals (WIMs) Collaborate on developing case report forms and clinical database to ensure quality data collection + Lead the efforts of data analysis for data monitoring committee as needed **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related field, 2 years' experience **What else we look for (Preferred):** + Training or publications in Bayesian methodology + Expertise in MS Office (Word, PowerPoint, Access, Excel) + Strong written/verbal communication and relationship management skills + Up-to-date on statistical and regulatory developments + Deep knowledge of clinical trial design, statistical modeling, and data analysis + Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA, ISO) for pharma/medical devices + Excellent problem-solving, analytical, and critical thinking skills + Proven leadership and ability to influence change + Skilled in training/coaching and facilitating organizational change + Detail-oriented; able to manage competing priorities in fast-paced environments + Professional interaction across all levels; collaborative team player and consultant to management 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 $129,000 to $182,000 (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. 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.

Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Manufacturing (Day Shift) Live What you will do Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be 10 hours shift Mon to Friday 6am to 4pm. The schedule will transition to a 12-hour night shift including every other weekend as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. Please note; no relocation assistance will be provided for these positions. With general direction, the Associate will support all floor operations in accordance with cGMP practices. Responsibilities will include... Compliance: Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance Assure proper gowning and aseptic techniques are always followed Process/Equipment/Facilities: Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area Run and monitor critical process tasks per assigned procedures Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]) Complete washroom activities: cleaning equipment, small to large scale, used in production activities Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions Perform documentation for assigned functions (i.e., equipment logs, EBRs) Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities Maintain an organized, clean, and workable space Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications. Basic Qualifications: High School/GED + 2 years manufacturing and/or other regulated environment experience Or Associate's Degree + 6 months manufacturing and/or other regulated environment experience Or Bachelor's Degree Preferred Qualifications: Completion of NC BioWork Certificate Program Experience in a regulated industry such as biotechnology or pharmaceutical Basic understanding and process experience in a cGMP manufacturing facility Excellent verbal and written communication Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible No relocation assistance will be provided for these positions Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com #AmgenNorthCarolina Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 75,618.00 USD - 89,473.00 USD

Territory covers: Fayetteville, Lillington, Dunn, Benson, Angier, Wallace, Burgaw, Rose Hill, etc. NC. 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. Specialty Representative/Senior Specialty Representative Live What you will do Let's do this. Let's change the world. In this vital role you will be the connection to our customers by providing clinical knowledge of our products to medical professionals and helping them navigate the complex payer environment. We are actively searching for a Specialty Representative or Senior Specialty Representative to deliver on our commitment to serve patients. The Specialty Representative/Senior Specialty Representative acts as the primary customer contact and is responsible for implementing marketing strategy and promoting Amgen products as led by the District Manager. Amgen supports and encourages our team members to have long term, fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this opportunity to craft a long-term career with Amgen. The Specialty/Senior Specialty Representative acts as the primary customer contact and is responsible for implementing marketing strategy and promoting Amgen products as led by the District Manager. Responsibilities include: * Provide current and comprehensive knowledge of Amgen's products and effectively communicate the clinical benefits to medical professionals to drive appropriate utilization of the products. * Perform as a sales leader to achieve territory sales by delivering branded sales messages, conducting planned programs, scheduling and following up on medical educational programs, and achieving or exceeding sales targets through both in-person and virtual engagement. * Develop relationships to service and manage accounts, including customizing discussions and customer interactions based on an understanding of customer needs, ensuring product access, resolving or triaging reimbursement issues, and maintaining product contracts. * Provide feedback on marketing strategy, analyze the business effectiveness of sales activities and territory performance, and develop territory plans in partnership with the District Manager. * Partner with other colleagues to share best practices and continuously learn and grow as a Specialty Representative or Senior Specialty Representative. * Demonstrate passion for Amgen's products and sustain that passion throughout the entire sales cycle, consistently building the brand while keeping patient impact at the forefront. * Uphold Amgen values by being science-based, competing intensely to win, creating value for patients, staff, and stockholders, acting ethically, fostering trust and respect, ensuring quality, working in teams, and collaborating, communicating, and remaining accountable. Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The sales professional we seek is a go-getter with these qualifications. Basic Qualifications Specialty Representative: * Bachelor's Degree OR * Associate's degree and 4 years of Sales experience OR * High school diploma/GED and 6 years of Sales experience Basic Qualifications Senior Specialty Representative: * Bachelor's degree and 3 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related OR * Associate degree and 6 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related OR * High school diploma / GED and 8 years of sales experience and/or clinical experience in healthcare / scientific field that is not sales related Preferred Qualifications: * Sales, marketing, and or clinical experience within the pharmaceutical, biotech, diagnostics, healthcare insurance, pharmacy services, healthcare medical device, or medical supply industries. * Some experience and or pre-graduate sales training and or a proven track record of successful leadership under pressure, preferred for the Specialty Representative level. * Three or more years of experience, preferred for the Senior Specialty Representative level. * Product or hospital sales experience in areas such as oncology, cardiology, inflammation, nephrology, dermatology, rheumatology, neurology, endocrinology, hepatology, gastroenterology, bone health, respiratory, hematology, or infectious diseases, including knowledge of the diseases and treatments within these specialties. * Advanced influencing and relationship-building skills with a focus on driving sales outcomes. * Local market knowledge. * Bachelor's degree in Life Sciences or Business Administration. * Adaptability to Amgen's core competencies, including sales planning and organizing, leveraging business, industry, and technical knowledge, communicating with impact, driving for results, and cultivating internal and external relationships. Thrive 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 Specialty Representative in the U.S. (excluding Puerto Rico) is $91,720 to $108,152. The expected annual salary range for Senior Specialty Representative in the U.S. (excluding Puerto Rico) is $121,378 to $149,742. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models, including remote and hybrid work arrangements, where possible Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range *

Career CategoryQualityJob 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 Investigations What you will do Let's do this. Let's change the world. In this vital role, you will be a key member of the team that investigates major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. You will communicate and interface between the GMP manufacturing teams and stakeholder groups including, Process Development, Facilities & Engineering, Automation, EHSS, and Quality. This position is responsible for ensuring deviation investigations are successfully conducted and documented while driving improvements in the investigation process. Manage Major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings. Drive improvements to the investigation process. Present investigations to regulatory inspectors, internal auditors, and management. Clearly communicate investigation progress to impacted areas and leadership. Coordinate and effectively lead cross-functional teams through complex investigations, and complete milestones on-schedule. Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues. Build effective relationships across functions. Navigate through ambiguity and provide a structured problem-solving approach. Apply inductive and deductive reasoning in the investigation process Clear and concise technical writing Use Operational Learning Team strategies to promote open collaboration with staff to maximize investigation findings. Develop tracking tools to ensure on-time closure and proactive review of deviation investigations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The collaborative investigator we seek has a biologics Drug Substance manufacturing and investigations background with strong cross-functional project management and communication skills as well as the below qualifications. Basic Qualifications: High school diploma / GED and 10 years of Quality Control experience OR Associate's degree and 8 years of Quality Control experience OR Bachelor's degree and 4 years of Quality Control experience OR Master's degree and 2 years of Quality Control experience OR Doctorate degree Preferred Qualifications: 5+ years related work experience (manufacturing, process development, or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility Experience with compliance, problem-solving, simple and complex root cause analysis tools (5-whys, fishbone, Kepner Tregoe Problem Analysis , Design of Experiment etc.) critical thinking, project management, and quality systems. Degree in Science or Engineering Experience leading complex investigations Experience using Veeva QMS for Deviation investigations and CAPAs Demonstrated project management ability Experience presenting to inspectors during regulatory inspections and internal audits. Excellent written and verbal communication skills Ability to work in a team matrix environment and build relationships with partners Strong interpersonal skills 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 114,990.00 USD - 139,433.00 USD

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. Medical Science Liaison - Obesity - NC Territory will include North Carolina What you will do Let's do this. Let's change the world. The Medical Science Liaison (MSL) acts as the primary scientific/clinical resource to Opinion Leaders (OLs), Population Heath Decision Makers (PHDMs) and other healthcare providers and is responsible for executing Amgen Medical function and product strategy as led by MSL Leadership, with the goal of giving accurate information to OLs, community healthcare providers and PHDMS to improve patient outcomes. The Obesity MSL is a field-based position within the U.S. Medical team reporting to the Obesity MSL Lead. Responsibilities include: * Majority of time spent on peer-to-peer activities with Obesity and related conditions Opinion Leaders, community healthcare providers, and PHDMs to discuss and advance the scientific platform as aligned with Amgen's company goals and objectives. * Engage with clinical investigators and sites in support of the obesity pipeline. * Engage with PHDMs within assigned IDNs and other institutions to communicate scientific based data of clinical value, outcomes, and economic data. * Connect external and internal stakeholders to amplify Amgen's reach and access for patients. * Conduct in-depth scientific exchange to provide focused and balanced clinical and scientific information consistent with MSL compliance standards. * Support Amgen sponsored research and may serve as a study lead. * Liaise with potential investigators in non-sponsored clinical research. * Provide and/or present field observations and insights to internal stakeholders to inform Amgen strategies. * Lead and support congress activities as aligned with strategy. * Support speaker training as requested and ensure the speakers are updated on new data. * Lead and/or participate on project teams that support MSL strategies and tactics as delegated by MSL leadership. * Compliantly partner across all Amgen field roles who share customers to create an appropriately coordinated One Amgen experience. * MSLs instill passion and move HCPs to take action in improving patient care related to closing care gaps * Mentor other MSLs as designated by MSL leadership. * Execute all administrative responsibilities and training (e.g., Veeva CRM, expense reports, compliance modules, etc.) in a timely manner. * Maintain and improve clinical/scientific acumen and expertise with current data/information and healthcare trends. * Ability to build and maintain strong relationships with external stakeholders and possess excellent communication skills to effectively communicate scientific data. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a strong collaborator with these qualifications. Basic Qualifications: * Doctorate degree OR * Master's degree & 3 years of Medical Affairs experience OR * Bachelor's degree & 5 years of Medical Affairs experience Preferred Qualifications: * Pharm.D., Ph.D., M.D. or D.O. (other doctoral degrees considered) * 1+ years Medical Affairs experience * 4 or more years in a medically related field, including 1 year focused on clinical practice, clinical research, or medical research. Experience in a medically related field can include post-doctoral training (i.e., residencies and/or fellowships) * Current experience in Scientific Affairs or Medical Affairs at a biotech or pharmaceutical company * Cardiometabolic and/or Obesity expertise * Experience with designated territory What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: * A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts * A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan * Stock-based long-term incentives * Award-winning time-off plans * Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. . Salary Range 162,346.00 USD - 194,596.00 USD

Career CategoryProcurementJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manufacturing Procurement Site Lead What you will do Let's do this. Let's change the world. We are seeking an individual who thrives in ambiguity and is capable of driving procurement outcomes in a manufacturing operations environment with strategic vision and precision. In this vital role you will oversee the operations and management of manufacturing procurement at one of Amgen's world class global manufacturing sites. This position will play a key role in ensuring procurement deliverables support effective and efficient site-based manufacturing activities, while maintaining compliance with regulatory requirements, and driving continuous improvement in manufacturing operations. Reporting to the Manufacturing Site Lead within Internal & External Manufacturing, you will also act as the lead procurement business partner for the Site Head and their functional and cross-functional leadership team, connecting procurement outcomes to strategic business objectives at the site. Roles & Responsibilities: Drive continuous improvement Procurement initiatives by identifying inefficiencies, recommending solutions, and implementing changes to enhance manufacturing performance, speed, and delivery. Champion a multi-year pipeline of savings and value plans across the manufacturing site that alignment with category and business strategies delivered against Finance's annual budget plan Be a trusted advisor across the Site Leadership Executive teams - ability to grow and maintain influence of Sourcing Agenda and delivered through strategic business partnership Be a Procurement leader with strong financial competence, experienced with accountability to site Executives and cross-functional leaders Lead with a commitment to continuous improvement in sourcing processes, tools and operating model; Develop goals and prioritize impact to site work among multiple initiatives; Courage to provide performance feedback across the category and sourcing teams Connect the dots and translate central functional programs into site based deliverables and outcomes Champion supplier relationship management for critical suppliers at the site level Identify and mitigate supply risk while ensuring Procurement deliverables adhere to regulatory requirements (e.g., GLP, GMP, ISO) and implement quality control systems, including audits, inspections, and compliance-related activities. Monitor and report on Procurement performance metrics, making necessary adjustments to meet organizational goals and identifying opportunities for cost savings and process improvements. Evaluate and implement, through Procurement, process improvement, environmental sustainability, and automation initiatives to enhance operational efficiency and support long-term goals. Maintain up-to-date knowledge of industry standards and best practices, sharing innovative procurement solutions within the global manufacturing operations network. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree and 2 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Or Master's degree and 4 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Or Bachelor's degree and 6 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Or Associate's degree and 10 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Or High school diploma / GED and 12 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Preferred Qualifications: In-depth knowledge of procurement best practices across manufacturing, capital, equipment, and technologies. Familiarity with industry standards and regulations (e.g., GLP, GMP, ISO, OSHA). Proven track record to drive value in a procurement environment supporting manufacturing Strong analytical skills to monitor performance metrics, optimize procurement deliverables, and ensure compliance. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $145,239 to $170,803. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range -

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. 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. Must reside within a commutable distance of Cary, NC or Fort Worth, TX. Shift Information Cary, NC - Monday-Friday from 9am-6pm EST and one night per week rotating to work 11-8pm. Fort Worth, TX - Monday-Friday from 8am-5pm CST and one night per week rotating to work 10-9pm. The nurses are required to report to the office twice a month for training and special meetings. One rotating Saturday. 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 Requirement Degree or equivalent and typically requires 4+ of relevant experience or a combination of education and experience. Active RN license in NC/TX. Education Associates, Bachelor or higher degree in Nursing or accredited nursing diploma. 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. Physical Requirements Large percent of time performing computer-based work is required. Hybrid position-Office days required. 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. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. 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. Our Base Pay Range for this position $31.00 - $51.66 McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson's (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application. McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates. McKesson job postings are posted on our career site: careers.mckesson.com. McKesson is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. Join us at McKesson!

Career CategoryMaintenanceJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Facilities Maintenance What you will do Let's do this. Let's change the world. In this vital role, you will be part of the Facilities organization within the Facilities & Engineering (F&E) team at Amgen's newest manufacturing site in North Carolina! System Owner responsibilities for facilities and utilities infrastructure systems including Building Shell & Core, Fire Protection & Suppression, Fire Alarm, Domestic Water, Sewer, etc, and supporting operations at the site. Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems. Support day-to-day logistics and overall coordination within the department and with project team. Attendance to whiteboard meetings, support and communication with the team. Ability to support end-to-end process for the creation of the Master Maintenance Packages including, but not limited to: Construction inspection walks Commissioning documentation Develop equipment/instrument maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order. Asset Creation / Preventive Maintenance Creation / Job Plan creation and overall ownership of systems within the Computerized Maintenance Management System (CMMS) Define spare parts' list, responsible for assessment with regards to criticality of spares Develop and assist in redlining and workflow process for SOP's relevant to the Facilities department Collaborate with peers to streamline or construct efficient Workflows/Business Practices Support of field walks, and general activities leading up to and at startup of systems; which includes but it is not limited to inspection field walks, punch list items generation, and inspection of equipment for Mechanical Completion Work with technicians and system owners to develop the scope of work, resource requirements, and parts requirements to complete preventive and corrective maintenance tasks in a safe, compliant, efficient, and effective manner Write clear, concise, and accurate Job Plan steps within the CMMS for corrective and preventive maintenance work orders Review turnover documentation and observe/document required spare parts for commissioning runs and future state operations Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations. Collaborate with integrated facilities management team and craft groups to schedule maintenance activities as required to support site operations Support maintenance activities to allow efficient labor utilization of F&E crafts while minimizing the interruption to customer operations. Identify and coordinate contractor resources as needed to effectively complete tasks Overall Facilities Compliance: Owner for Facilities Standard Operating Procedures Responsible for reviews, updates and administration of SOP's for Facilities Department Owner of change controls - end to end process Owner of deviations and corrective actions Assist with Procurement and Invoicing for the department Provide technical support and issue resolution with 24x7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays). Data verification of GMP information for pest control compliance Delegate for Facilities Sr Manager during period of absence Day-to-day management of communication and any other tasks/projects assigned as per manager's request What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications. Basic Qualifications: High School Diploma / GED and 6 years of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR Associate's Degree and 4 years of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR Bachelor's Degree and 2 months of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR Master's Degree Preferred Qualifications: Experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of current Good Manufacturing Practices Strong customer service skills, written and verbal communication skills, and the ability to work with minimal direction Demonstrated ability to function within cross-functional teams and embrace a team-based culture Ability to use Microsoft Excel, Word, PowerPoint, SharePoint, Smartsheet, and various database querying tools Good understanding of CMMS systems (Maximo, SAP, Blue Mountain, ETC.) Familiar with Root Cause Analysis and LEAN methodology Excellent facilitation, organizational and planning skills Proactive, self-starter with the ability to take on several projects at one time What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 94,978.00 USD - 114,953.00 USD

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

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. Director, Manufacturing Support What you will do Let's do this. Let's change the world. In this vital role you will be accountable for lifecycle management, electronic batch records, cleaning & sterilization validation, single use system implementation and support, process ownership, deviation investigations and corrective actions, and technical training for manufacturing. Agile and reliable product lifecycle management New technology implementation and digital advancements Electronic batch record configuration and maintenance Strategy and maintenance of cleaning and sterilization validation programs Single use system design, deployment, and defect support Process ownership inclusive of deviation investigation, CAPA, change control, and project management Finite scheduling of plant operations Technical training for manufacturing staff The leader will direct staff to ensure plant goals are met and represent the manufacturing organization on projects, site and network teams. The leader is expected to: Anticipate and adapt to environmental factors Champion innovation and continuous improvement Create compelling strategies the help deliver the company's aspiration Recruit, retain and develop high-performing and diverse teams Set challenging performance expectations and provides timely feedback Build empowered teams that put patients and Amgen first Establish sound plans the enable Amgen's operational and strategic imperatives Execute with a sense of purpose and drives course correction where appropriate Deliver strong results consistent with compliance requirements and Amgen values. Specifically, the responsibilities for this position are: Collaborate with cross-functional teams to complete production enabling activities Drive continuous improvement initiatives, programs and projects Deploy new manufacturing technologies to advance manufacturing strategy Ensure that the requirements of the Quality Management System are fulfilled Alert senior management of significant quality, compliance, supply and safety risks Provide input for management reviews Forecast and adhere to a budget for assigned areas What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek is a leader with these qualifications. Basic Qualifications: Bachelor's degree and 10 years of manufacturing experience OR Master's degree and 8 years of manufacturing experience OR Doctorate degree and 4 years of manufacturing experience And In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Currently in a leadership position in a GMP manufacturing plant Experience in drug substance manufacturing operations for commercially licensed products Experience with the process validation lifecycle inclusive of process design, process performance qualification, and continued process verification 6 years managing a team, leading and managing operations 2 years experience in applying operational excellence and lean manufacturing principles to drug substance manufacturing Excellent communication and negotiation skills including executive level communication Experience in a matrixed, cross-site or global network environments 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 190,965.00 USD - 225,559.00 USD

Career CategoryQualityJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager Quality Assurance - Incoming Quality Assurance Raw Materials /Disposition What you will do Let's do this! Let's change the world! In this vital role, you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations. Specific responsibilities include but are not limited to: Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations). Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements. Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring. Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations. Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays. Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact. Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program. Represent the Quality unit during internal and external audits and regulatory inspections. Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed. Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline. What we expect of you We are all different, yet we all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong leader with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR Associate's degree and 10 years of Quality and Manufacturing support industry experience OR Bachelor's degree and 8 years of Quality and Manufacturing support industry experience OR Master's degree and 6 years of Quality and Manufacturing support industry experience OR Doctorate degree and 2 years of Quality and Manufacturing support industry experience Preferred Qualifications: Educational background in Life Science and/or Engineering Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems. In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice. Hands-on experience with Disposition, Incoming, and Quality Systems-particularly investigations, corrective actions, and audit readiness. Experience managing and interacting with regulatory and internal auditors. Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills. Effective risk management, negotiation, and cross-functional collaboration abilities. Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 154,692.00 USD - 188,725.00 USD

Career CategoryScientificJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Process Development Senior Associate What you will do Let's do this. Let's change the world. In this vital role you will work in a team environment to contribute to drug substance process development Execute mammalian cell culture experiments at different scales in shake flasks and bioreactors Execute purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed Document experimental data in lab notebooks Communicate findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings) Contribute to technology development projects to seek continuous improvement in reliability and efficiency What we expect of you We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications. Basic Qualifications: High school diploma / GED and 6 years of life sciences industry experience OR Associate's degree and 4 years of Quality Control experience OR Bachelor's degree and 2 years of Quality Control experience OR Master's degree Preferred Qualifications: Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing field or relevant experience in the pharmaceutical or related industry preferred. Relevant hands-on lab experience in cell culture or protein purification. Proven ability to identify and tackle problems by applying scientific and engineering principles, preferably in a process development environment Experience in Design of Experiments and statistical analysis is a plus. Good oral and written communication skills. Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 86,613.00 USD - 104,742.00 USD

Career CategoryProcess DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Scientist, Process Development (Process Validation & Business Strategy) What you will do Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen's FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes process development operation support, developing digital tools to support business processes, and support commercial development of Amgen's pipeline. The role will be responsible for ensuring PD business strategy operations have appropriate digital tools to track operational metrics for safety, training, compliance, support business processes improvements, and the commercial development of the Amgen's pipeline. In addition, the role will be responsible for supporting tech transfer activities as needed. Lead and develop the Process Development safety, training, and compliance monitoring operation Holistic Lab Execution Environment (HLEE) champion for the process development lab Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation Develop digital tools to support process validation and process monitoring activities Support and develop the Amgen North Carolina (ANC) PD DST knowledge management ecosystem, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process. Provide process floor or lab support as required What we expect of you We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications. Basic Qualifications: Bachelor's degree and 3 years of Process Development or Scientific experience OR Master's degree and 1 years of Process Development or Scientific experience Preferred Qualifications: 2 - 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role. Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes Familiarity in operational aspects of process development lab or commercial biopharma manufacturing Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, spotfire, and/or databricks Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements Excellent written and verbal communication Be a self-starter with the ability to take on several projects at one time. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 97,377.00 USD - 118,653.00 USD

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. Manufacturing Systems Engineer: Automation - PLC What you will do Let's do this. Let's change the world. As a Manufacturing Systems Engineer, you will work with 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 automation systems to operate the new plant utility and standalone systems. This includes sophisticated and challenging system automation initiatives that require understanding of various automation platforms, integration between different platforms, analytical problem-solving techniques, project management, lifecycle management and Operational Excellence. Develop and maintain automation solutions using various PLC's such as Allen Bradley, Siemens, etc. and integration with the Emerson DeltaV system. Develop and maintain Supervisory Control and Data Acquisition system (SCADA), Trailblazer reporting system, and equipment PLC's and interface hardware. Support standalone system implementation and start-up, participate and provide technical guidance in the control panel / Human Machine Interfaces (HMI) layout and design including power distribution, grounding requirements, I/O assignments, etc. Work with process subject matter experts (SMEs) to understand key process requirements and transform them into digital automated solutions. Assist in continuous improvement and innovation initiatives for efficient operation and sustainability improvements of standalone systems. Collaborate with business partners to understand how standalone systems can improve workflow and productivity. Synthesize requirements from clients, customers, or end-users to develop the best automation solutions. Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Amgen and Industry standards. Build the business processes to support the project scope in alignment with project timelines. Develop detailed specification and engineering policies and procedures that affect multiple organizational units. Ongoing operations: Support functional area projects focused on improving process equipment/utilities/facilities as well as large/sophisticated capital projects to integrate new drug substance manufacturing technologies into the facility. Support technical root cause analysis, incident investigations, and troubleshooting on standalone systems. Support new product introductions (NPI) or new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable. Assist with Day-to-Day Operational Support including: 24 x 7 Onsite/On Call Operational Support, Troubleshooting Support to Standalone Systems, Preventative and Corrective Maintenance, and Automation System spare parts management. Be constantly curious and feed your passion and interests in groundbreaking technology. Use your given time to look for new and innovative ways to do business differently, better, and more cost effectively. What we expect of you! We are all different, yet we all use our unique contributions to serve patients. The automation professional we seek is an engineer with these qualifications. Basic Qualifications: High School Diploma / GED and 8 years of Engineering experience OR Associate's Degree and 6 years of Engineering experience OR Bachelor's Degree and 2 years of Engineering experience OR Master's Degree Preferred Qualifications: Degree in Electrical Engineering or Computer Science, Chemical Engineering, or Biotech Engineering. Direct knowledge of PLC design, experience in controls engineering and troubleshooting with GMP biopharmaceutical production facility and utility equipment/systems automation such as autoclaves, parts washers, clean steam generator, WFI pretreatment RO, WFI stills, filter integrity testers, wastewater treatment systems, and integrating various OEM automation software. Extensive understanding and background in programming, design, installation, and lifecycle management of standalone controls, PLC, and field device/instrumentation technologies. Experience with Rockwell industrial automation hardware and systems, ability to perform sophisticated troubleshooting activities, System Integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet 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. Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, business case development, detailed design, engineering and validation documentation and project execution. Hands-on experience in developing process control strategies for New Product Introduction and New Technology Deployment for Drug Substance Plant Operations. Experience with continuous improvements resulting in enhanced safety, system reliability, and productivity (e.g., cycle times, and reduced plant utilities usage etc.) related to Drug Substance Plant Operations. The ideal individual must be a self-directed great teammate ready to embrace a team-based culture that relies on collaboration for effective decision-making. Strong technical writing and communication/presentation skills. 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 118,497.00 USD - 134,250.00 USD

Career CategoryQualityJob 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, Quality Control Microbiology What you will do Let's do this. Let's change the world. In this vital role, you will manage the Sampling and Testing teams within the Quality Control Microbiology laboratory. This role oversees routine environmental monitoring, clean utilities' monitoring, and routine microbiological testing to support drug substance manufacturing. The Manager, Quality Control Microbiology will report directly to the Senior Manager of Quality Control Microbiology. Directly supervise Microbiology staff supporting routine Environmental monitoring and utilities monitoring sampling and testing, and production in-process and final drug substance testing. Manage the training program for sampling and testing team. Assist with planning, scheduling, and lead execution of EMPQ and Clean Utilities qualification activities to support facilities changes. Assist the Environmental Monitoring and Utilities Monitoring program owner with sampling scheduling, coordinating activities with manufacturing operations, reviewing and interpreting data, and writing trend reports. Act as Subject Matter Expert for method families and testing platforms used in the microbiology department. Work cross-functionally with Manufacturing, Analytical Sciences, Facilities & Engineering, and Quality teams to align processes with business needs. Author, revise, and review documents and reports including but not limited to: SOPs, safety assessments, trend reports, qualification/validation summary reports, microorganism assessments, and technical reports. Represent the microbiology department during agency inspections and internal audits. Work closely with the global Quality Control organization to drive standardization of testing processes and procedures. Own, manage, and participate in deviations, CAPAs, and cross functional investigations. Lead process improvement projects that may be local or global in scope. Support routine activities over the weekends and public holidays as required. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Manager Quality Control Microbiology we seek is a dynamic, flexible, and driven individual with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality or Aseptic Manufacturing experience OR Associate's degree and 10 years of Quality or Aseptic Manufacturing experience OR Bachelor's degree and 5 years of Quality or Aseptic Manufacturing experience OR Master's degree and 3 years of Quality or Aseptic Manufacturing experience OR Doctorate degree And In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above Preferred Qualifications: Experience working in a GMP pharmaceutical production facility with classified areas and applicable gowning requirements. Strong leadership skills, with the ability to manage multiple direct reports. Degree in Microbiology, Biology, Biochemistry, or related scientific field. Experience with environmental monitoring and clean utilities monitoring, including execution of EMPQ and trending of EM/utilities data. Experience with microbiological quality control testing, including but not limited to: Endotoxin, Bioburden, Microbial Identification, TOC. Experience with equipment validation. Solid understanding of aseptic technique. Strong written and verbal communication skills, including technical writing and technical presentations. Able to flexibly work independently, as a project owner, collaboratively on group tasks, and as a trainer. 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 122,421.00 USD - 142,851.00 USD

Career CategoryQualityJob 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. Quality Assurance Specialist What you will do Let's do this. Let's change the world. In this vital role you will serve as Quality Assurance Specialist responsible for Plant Quality Assurance (PQA). This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff. Amgen's Quality Assurance Specialist provides coaching, guidance and direction to Manufacturing, Quality Control, Supply Chain and Facilities & Engineering staff in regard to compliance and quality systems. Responsible for providing Quality oversight to ensure that Operations' products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations. Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls. Performs review and approval of cGMP processes, procedures, documents and records, including but not limited to Batch Production Records, Deviations, work-orders, Change Controls and Corrective Action/Preventative Actions (CAPA) Author/review/approve quality documents, such as SOPs, user requirements, risk assessments, training materials, engineering documents, automation documents, environmental qualification protocols/reports, validation protocols/reports. Oversee and provide guidance during on-the-floor analytical testing. Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements. Ensure that changes that could potentially impact product quality are assessed according to procedures. Ensure that deviations from established procedures are investigated and documented per procedures. Alert senior management of quality, compliance, supply and safety risks. Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation. Identification and implementation of continuous improvement opportunities within our processes and systems Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Quality Assurance professional we seek is a Specialist with these qualifications. Basic Qualifications: High school diploma / GED and 10 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Associate's degree and 8 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Bachelor's degree and 4 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Master's degree and 2 years of Quality, Manufacturing, Process Development or Process Engineering experience OR Doctorate degree Preferred Qualifications: Educational background in Life Science or Engineering. Understanding of regulations, standards and guidelines that apply to cGMP biotech manufacturing in a multi-product environment including familiarity of cell banking, cell culture, and protein purification operations. Experience with Quality Management Systems, including Exceptions, Change Control, Risk Management and Disposition Familiarity with Computer / Automation systems (MES, Delta-V, PI data historian) Capability to build strong and collaborative partnerships with client groups and influence changes in practices to ensure compliant operations. Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations. Experience participating in, managing, and responding to health authority inspections, partner and corporate audits. Strong organizational skills, including ability to follow assignments through to completion. Excellent written and verbal communication skills. 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 113,191.00 USD - 131,832.00 USD

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. . Salary Range 119,195.00 USD - 147,867.00 USD

**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.

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. **You will make an impact by...** + Leading a team of biostatisticians, shaping clinical study design and data analysis to drive new product innovation + Providing technical and strategic leadership for multiple complex clinical programs, collaborating with cross-functional teams + Overseeing the biostatistics team, managing budgets to maximize research impact + Defining statistical methodologies and real-world evidence strategies, influencing research publications and regulatory success + Acting as the lead biostatistician for assigned clinical trials, ensuring statistical integrity and meaningful insights + Developing and implementing talent development plans, fostering leadership within the biostatistics team + Driving complex biostatistics strategies, engaging with both internal and external stakeholders + Spearheading process improvement initiatives to enhance efficiency across biostatistics and cross-functional areas + Establishing and optimizing SOPs, processes, and standards to ensure accuracy and compliance + Managing high-impact activities, proactively addressing risks and resolving issues collaboratively + Providing statistical expertise to key stakeholders, including marketing, health economics, and reimbursement teams + Overseeing resource analysis and planning, ensuring optimal support for biostatistics functions + Ensuring clinical trial integrity and success for direct reports and assigned studies + Contributing to additional initiatives that shape the future of medical device development **What you'll need (Required):** + Ph.D. or equivalent in Statistics, Biostatistics, or related with previous analytical experience in clinical trials + Demonstrated ability to manage one or more teams and provide and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations **What else we look for (Preferred):** + Proven leadership managing teams and projects, driving innovation, excellence, and successful delivery of complex initiatives + Extensive biostatistical experience applying complex methodologies and analyzing clinical trials data + Deep expertise in clinical trial design and statistical methodology, solving complex challenges and driving innovation + Extensive experience on publications and real-world evidence generation, ensuring meaningful impact in clinical outcomes + Strategic understanding of biostatistics processes and systems, enabling optimal application across multiple projects + Exceptional communication and negotiation skills, leveraging data-driven insights to influence decision-making + Proven ability to coach, support, and manage direct reports across all aspects of employee relations + Meticulous attention to detail ensuring accuracy, compliance, and integrity in statistical analyses and reporting + Professional presence across all organizational levels, proactively addressing and escalating issues as needed + Ability to thrive in fast-paced, dynamic environments and adapt to evolving priorities + Regular engagement with senior stakeholders to shape operational decisions and influence strategic direction + Lead technical meetings and briefings, collaborating with internal and external representatives to drive initiatives forward + Build strong relationships and cross-functional partnerships, establishing best practices and advancing global enterprise systems + Commitment to quality client service, responding proactively to stakeholder needs and challenges + Key role in influencing organizational change, leveraging relationships and insights to drive transformation + Strong change leadership skills, capable of driving consensus in complex or sensitive situations + Expertise in statistical programming (SAS and/or R) for advanced clinical analyses and impactful research + Strong proficiency in Microsoft Office Suite to support analytical and reporting functions + \#-LI-Remote + 5-10% Travel to our corporate office in Irvine, California is required if you are hired as a remote employee 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. The base pay range for this position is $205,000 to $255,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. 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.