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Stryker jobs in Raleigh, NC - 158 jobs

  • Field Clinical Specialist - Raleigh, NC - Inari Medical

    Stryker 4.7company rating

    Stryker job in Durham, NC

    Work Flexibility: Field-based The Field Clinical Specialist works using independent judgement, partners with local Account Managers to increase clinical support, education resulting in increased clinical acumen. Responsibilities Educate physicians on device handling, implantation and troubleshooting techniques related to Inari products. Develop, lead and/or facilitate training sessions and in-service education programs in the hospital environment. Identify therapy adoption opportunities in collaboration with Regional and Account Managers in local geographies. Communicate highly technical information clearly and effectively during fast-paced procedures. Act as a clinical interface between the medical community and the Company. Demonstrate ability to build and sustain credible business relationships with customers and share product expertise accordingly. Provide education and clinical support in response to the most complex field inquiries on an as-needed basis. Demonstrate a thorough understanding of all Inari products, related products and technical knowledge, trends, and players. Collaborate with product development teams to provide feedback on device features and new device development Document procedural case observations for regulatory requirements and ongoing continuous improvement Other duties as needed. Qualifications Bachelor's degree preferred or Associates Degree in nursing or clinical required Minimum of three (3) years; in medical device clinical capacity or cath lab. Proven understanding of cardiovascular science, cardiovascular anatomy, pathology and physiology Strong clinical acumen is required. Understanding of sales process is a plus. Travel up to 80% of the time - both locally and regionally, and occasionally overnight. Night/weekend on call per preplanned scheduled. Extensive sitting, standing, and speaking. Light lifting to 10 pounds. Must be open to a dynamic work environment which includes regular interaction with several different physician and hospital staff customers in several locations. Must have desire to participate in a healthcare team in the treatment of patients and anticipate needs of others. Apply critical thinking skills to solve complex clinical problems. Excellent command of the English language with comprehensive written and verbal communication, interpersonal, analytical, and organizational skills. Must have the ability to concentrate on detail and work independently and meet deadlines with strong attention to detail Comprehensive computer skills with experience in Microsoft Office with ability to develop presentation materials. Base/Draw + commission: $State established rate or range for salary and may be eligible to earn commission and/or bonuses + benefits. #LI-REMOTE Travel Percentage: NoneStryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain the COVID-19 vaccination as an essential function of their role.
    $94k-130k yearly est. Auto-Apply 12d ago
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  • Sales Representative - Raleigh, NC - Injury Prevention

    Stryker 4.7company rating

    Stryker job in Raleigh, NC

    Work Flexibility: Field-based Sage Sales Representative As a Sage Sales Representative at Stryker, you will be at the forefront of promoting and selling our Sage products. You will drive the sale of innovative products that are designed to address preventable never-events, while maximizing efficiency and profitability for healthcare facilities. Your role will involve building and maintaining strong customer relationships, addressing inquiries, negotiating pricing, and managing orders seamlessly. By staying informed on industry trends, competitor activity, and regulatory shifts, you'll position Stryker's products effectively in the marketplace. You'll also have the opportunity to exceed sales targets, monitor your performance, and collaborate with marketing and support teams to drive business growth and success. As a Sage Sales Representative, you are driven to solve real problems and make healthcare better for our customers and the patients they serve. What you will do Continue experience in sales or clinical setting. Achieve your assigned quota by building and maintaining a working relationship with key influencers in accounts, distributor contacts and end-users for continued defense of your base of business. Become the resident Sage expert as you work with a sophisticated audience of clinical specialists, nurses, educators and administrators. Your knowledge not only of your own products, but of competitors' offerings, builds credibility with your customers. Focus on customer satisfaction by demonstrating teamwork and empowerment, solving problems through a consultative approach, operating with honesty and integrity and providing a highly responsive and unsurpassed level of customer service. Drive protocol and process improvement by partnering with your customers to enhance outcomes and deliver clinical and financial improvements. Establish yourself as a consultant to your customer by bringing a high level of clinical knowledge and overall healthcare insights. Have knowledge of marketing, market research, new product development, new product introduction, Profit and Loss (P&L) management, and field testing. What you need Required: 5+ years of professional experience Valid driver license in the state of residence and a good driving record. Preferred: Bachelor's Degree Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain the COVID-19 vaccination as an essential function of their role.
    $40k-56k yearly est. Auto-Apply 46d ago
  • Senior Manager Quality Control Support

    Amgen 4.8company rating

    Holly Springs, NC job

    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. Senior Manager Quality Control Support What you will do Let's do this. Let's change the world. In this vital role, Amgen is seeking a Senior Manager of Quality Control Support for our state-of-the-art manufacturing facility in Holly Springs, North Carolina. This leader will be responsible for overseeing key support functions within the QC organization, including laboratory systems, compliance, document management, sample lifecycle coordination, and continuous improvement initiatives. The role ensures alignment with cGMP standards, regulatory expectations, and Amgen's global quality systems. Strategic Leadership Lead and develop a high-performing QC support team with expertise in lab operations, documentation, and compliance systems. Drive alignment between site QC operations and global Amgen quality policies and procedures. Quality Systems and Compliance Ensure QC operations maintain inspection readiness at all times. Own and oversee laboratory deviation investigations, CAPA management, change control, and document lifecycle. Operational Support and Optimization Oversee implementation and maintenance of LIMS, Empower, and other QC systems. Manage QC scheduling, sample logistics, and coordination with internal/external stakeholders. Lead and support digital and lean initiatives to improve lab efficiency, throughput, and compliance. Talent Development and Cross-functional Engagement Recruit, mentor, and develop team members to build a robust talent pipeline. Partner with Quality Assurance, Analytical Sciences, Manufacturing, and Regulatory to ensure seamless quality operations. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Senior Manager Quality Control Support we seek is a dynamic, resilient, flexible, and driven individual with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality Analytical testing experience OR Associate's degree and 10 years of Quality Analytical testing experience OR Bachelor's degree and 8 years of Quality Analytical testing experience OR Master's degree and 6 years of Quality Analytical testing experience OR Doctorate degree and 2 years of Quality Analytical testing experience And 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. Preferred Qualifications: Master's degree or higher in a scientific or quality-related discipline Experience in new facility start-up or tech transfer projects Expertise in global regulatory requirements (FDA, EMA, etc.) Strong background in laboratory compliance, LIMS, LMES, CIMS, Veeva and Trackwise systems Lean Six Sigma or continuous improvement certification Exceptional communication, leadership, and problem-solving skills 2+ years of management experience at a senior level Strong Leadership, Collaboration and 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 151,584.00 USD - 182,019.00 USD
    $102k-134k yearly est. Auto-Apply 4d ago
  • Senior Associate Warehouse Systems

    Amgen 4.8company rating

    Holly Springs, NC job

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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 Warehouse Systems** **What you will do** Let's do this. Let's change the world. In this role, you will be part of the Supply Chain team, and you will participate in multiple cross-functional initiatives for Amgen North Carolina (ANC) warehouse. You will serve as warehouse Subject Matter Expert and as site representative on various cross-functional task forces and teams to ensure that consistent and well-integrated practices are developed throughout the organization. The focus of the Sr. Associate is to support warehouse process and systems, including floor support, gemba walks to ensure adequate safety and housekeeping practices, procedures drafting and approval, staff training and quality systems records, as well as warehouse equipment ownership. This position works close with Warehouse operations and Procurement to manage warehouse capacity actions. + Represent ANC Supply Chain in interdisciplinary system-related projects/initiatives and possibly lead work streams within such projects (e.g., process mappings with manufacturing) **.** + Own Warehouse Safety Program, investigations and actions. + Manage initiatives to support warehouse capacity constraints. + Conducts warehouse walks and tracks actions to completion. + Support Operational Excellence initiatives in Supply Chain processes, including data analysis and business case development. + Identify and manage warehouse risks. + Owns change control and deviations records if applicable. + Involvement in test process for new functionality. + Serve as first point of contact for Key Users in case of warehouse related issues + Own relevant Supply Chain procedures and conduct required periodic reviews **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The Supply Chain professional we seek is a leader with strong strategic problem solver with these qualifications. **Basic Qualifications:** + High school diploma/GED and 4 years of operations, business, or supply chain experience OR + Associates Degree and 2 years of operations, business, or supply chain experience OR + Bachelor's degree and 6 months of operations, business, or supply chain experience OR + Master's degree **Preferred Qualifications:** + Supply Chain & Logistics Management, Information Technology, or Engineering educational background. + Supply Chain experience with a focus on warehouse operations and systems + Basic knowledge of ERP (SAP) and SAP Warehouse Management (WM) + Good understanding of Warehouse Master Data and SAP + Knowledge of Information Technology, Supply Chain processes, and Operational Excellence + Good understanding of current Good Manufacturing/Distribution Practices + Quick process understanding, insight and visualizing + Experience in managing projects or work streams (cross functional) + Availability to support non-standard shift organization with the flexibility to work extended hours. + Good organizational and communications skills + Continuous improvement mentality. + Experience working in a global environment, ability to collaborate closely/communicate effectively at different management levels. + Proficient user of software applications (Excel, PowerPoint, Smartsheet, Skype, Tableau). + Consistent and strong communication within Supply Chain and throughout all of Amgen and across all sites. **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.
    $37k-46k yearly est. 5d ago
  • Associate Manufacturing (Day Shift)

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryManufacturingJob Description HOW MIGHT YOU DEFY IMAGINATION? You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Manufacturing (Day Shift) Live What you will do Let's do this! Let's change the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be 10 hours shift Mon to Friday 6am to 4pm. The schedule will transition to a 12-hour night shift including every other weekend as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. Please note; no relocation assistance will be provided for these positions. With general direction, the Associate will support all floor operations in accordance with cGMP practices. Responsibilities will include... Compliance: Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance Assure proper gowning and aseptic techniques are always followed Process/Equipment/Facilities: Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area Run and monitor critical process tasks per assigned procedures Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs]) Complete washroom activities: cleaning equipment, small to large scale, used in production activities Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions Perform documentation for assigned functions (i.e., equipment logs, EBRs) Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities Maintain an organized, clean, and workable space Win What we expect of you We are all different, yet we all use our unique contributions to serve patients. The hard-working professionals we seek are team players with these qualifications. Basic Qualifications: High School/GED + 2 years manufacturing and/or other regulated environment experience Or Associate's Degree + 6 months manufacturing and/or other regulated environment experience Or Bachelor's Degree Preferred Qualifications: Completion of NC BioWork Certificate Program Experience in a regulated industry such as biotechnology or pharmaceutical Basic understanding and process experience in a cGMP manufacturing facility Excellent verbal and written communication Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes Thrive What you can expect of us As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and bi-annual company-wide shutdowns Flexible work models, including remote work arrangements, where possible No relocation assistance will be provided for these positions Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com #AmgenNorthCarolina Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 75,618.00 USD - 89,473.00 USD
    $26k-35k yearly est. Auto-Apply 13d ago
  • Manufacturing Procurement Site Lead

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryProcurementJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manufacturing Procurement Site Lead What you will do Let's do this. Let's change the world. We are seeking an individual who thrives in ambiguity and is capable of driving procurement outcomes in a manufacturing operations environment with strategic vision and precision. In this vital role you will oversee the operations and management of manufacturing procurement at one of Amgen's world class global manufacturing sites. This position will play a key role in ensuring procurement deliverables support effective and efficient site-based manufacturing activities, while maintaining compliance with regulatory requirements, and driving continuous improvement in manufacturing operations. Reporting to the Manufacturing Site Lead within Internal & External Manufacturing, you will also act as the lead procurement business partner for the Site Head and their functional and cross-functional leadership team, connecting procurement outcomes to strategic business objectives at the site. Roles & Responsibilities: Drive continuous improvement Procurement initiatives by identifying inefficiencies, recommending solutions, and implementing changes to enhance manufacturing performance, speed, and delivery. Champion a multi-year pipeline of savings and value plans across the manufacturing site that alignment with category and business strategies delivered against Finance's annual budget plan Be a trusted advisor across the Site Leadership Executive teams - ability to grow and maintain influence of Sourcing Agenda and delivered through strategic business partnership Be a Procurement leader with strong financial competence, experienced with accountability to site Executives and cross-functional leaders Lead with a commitment to continuous improvement in sourcing processes, tools and operating model; Develop goals and prioritize impact to site work among multiple initiatives; Courage to provide performance feedback across the category and sourcing teams Connect the dots and translate central functional programs into site based deliverables and outcomes Champion supplier relationship management for critical suppliers at the site level Identify and mitigate supply risk while ensuring Procurement deliverables adhere to regulatory requirements (e.g., GLP, GMP, ISO) and implement quality control systems, including audits, inspections, and compliance-related activities. Monitor and report on Procurement performance metrics, making necessary adjustments to meet organizational goals and identifying opportunities for cost savings and process improvements. Evaluate and implement, through Procurement, process improvement, environmental sustainability, and automation initiatives to enhance operational efficiency and support long-term goals. Maintain up-to-date knowledge of industry standards and best practices, sharing innovative procurement solutions within the global manufacturing operations network. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. Basic Qualifications: Doctorate degree and 2 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Or Master's degree and 4 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Or Bachelor's degree and 6 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Or Associate's degree and 10 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Or High school diploma / GED and 12 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience Preferred Qualifications: In-depth knowledge of procurement best practices across manufacturing, capital, equipment, and technologies. Familiarity with industry standards and regulations (e.g., GLP, GMP, ISO, OSHA). Proven track record to drive value in a procurement environment supporting manufacturing Strong analytical skills to monitor performance metrics, optimize procurement deliverables, and ensure compliance. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $145,239 to $170,803. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team.careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range -
    $145.2k-170.8k yearly Auto-Apply 60d+ ago
  • Senior Associate Quality Assurance - PQA

    Amgen 4.8company rating

    Holly Springs, NC job

    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. Senior Associate Quality Assurance - PQA What you will do Let's do this. Let's change the world. The Amgen North Carolina (ANC) Sr. Associate Plant Quality Assurance (PQA) on-the-floor position will work directly with plant manufacturing and support groups for on-going bulk drug substance manufacturing and new product introduction-including development, clinical, and commercial operations. The Sr Associate PQA position will facilitate real-time decision making to ensure adherence to GMP quality requirements. This is a unique opportunity to maintain and further build a strong partnership and learning environment between Manufacturing and Quality staff providing coaching, guidance and direction for manufacturing events, deviations, quality systems and compliance. The Plant Quality Assurance team will work different shift structures to provide ongoing support to our functional teams and 24/7 operations. Support Quality Control Laboratories IQOQPQ, Equipment Qualification and Validation, perform quality review and approval of documents to support facility commissioning and qualification, according to project timelines. Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems and process with alignment into the Amgen Quality Systems. May include support on commissioning and qualification and validation activities in addition to new document support. Provide on-going Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation 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. Drive closure/completion (including review and approve) of cGMP processes, procedures, documents and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPA), change control records and validations. Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP and cGMP requirements. Oversee and provide guidance during on-the-floor analytical testing. 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 professional we seek is a collaborative partner with these qualifications. Basic Qualifications: High school diploma/GED and 4 years of Quality, manufacturing and/or other regulated environment experience OR Associate's degree and 2 years of Quality, manufacturing and/or other regulated environment experience, OR Bachelor's Degree and 6 months of Quality, manufacturing and/or other regulated environment experience OR Master's Degree. Preferred Qualifications: Strong cGMP and GDP behaviors Experience in biotechnology or pharmaceutical plant start up Knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems Demonstrated experience with deviations records Experience supporting GMP testing laboratories. Strong organizational skills and ability to manage multiple tasks at one time, ability to follow assignments through to completion and meet timelines Strong communication skills, both written and oral Demonstrated ability to work as a team player and independently 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 86,928.00 USD - 106,536.00 USD
    $66k-85k yearly est. Auto-Apply 7d ago
  • Process Development Senior Associate I

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryScientificJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Process Development Senior Associate What you will do Let's do this. Let's change the world. In this vital role you will work in a team environment to contribute to drug substance process development Execute mammalian cell culture experiments at different scales in shake flasks and bioreactors Execute purification experiments, mainly filtration and chromatography, at bench and pilot scale as needed Document experimental data in lab notebooks Communicate findings through oral presentations and written documentation (technical reports as well as GMP documents to support regulatory filings) Contribute to technology development projects to seek continuous improvement in reliability and efficiency What we expect of you We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications. Basic Qualifications: High school diploma / GED and 6 years of life sciences industry experience OR Associate's degree and 4 years of Quality Control experience OR Bachelor's degree and 2 years of Quality Control experience OR Master's degree Preferred Qualifications: Degree in Chemical Engineering, Biochemistry, Biotechnology, Bioengineering, Biomedical engineering, or Bioprocessing field or relevant experience in the pharmaceutical or related industry preferred. Relevant hands-on lab experience in cell culture or protein purification. Proven ability to identify and tackle problems by applying scientific and engineering principles, preferably in a process development environment Experience in Design of Experiments and statistical analysis is a plus. Good oral and written communication skills. Strong communication and interpersonal skills, and the ability to work flexibly in a dynamic and collaborative environment with diverse team members What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 86,613.00 USD - 104,742.00 USD
    $68k-82k yearly est. Auto-Apply 11d ago
  • Senior Associate Facilities Maintenance

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryMaintenanceJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Associate Facilities Maintenance What you will do Let's do this. Let's change the world. In this vital role, you will be part of the Facilities organization within the Facilities & Engineering (F&E) team at Amgen's newest manufacturing site in North Carolina! System Owner responsibilities for facilities and utilities infrastructure systems including Building Shell & Core, Fire Protection & Suppression, Fire Alarm, Domestic Water, Sewer, etc, and supporting operations at the site. Provide engineering support for design, construction, startup, commissioning and qualification of new or modified systems. Support day-to-day logistics and overall coordination within the department and with project team. Attendance to whiteboard meetings, support and communication with the team. Ability to support end-to-end process for the creation of the Master Maintenance Packages including, but not limited to: Construction inspection walks Commissioning documentation Develop equipment/instrument maintenance programs, ensure the availability of spare parts, and coordinate maintenance execution as necessary to ensure systems are in proper working order. Asset Creation / Preventive Maintenance Creation / Job Plan creation and overall ownership of systems within the Computerized Maintenance Management System (CMMS) Define spare parts' list, responsible for assessment with regards to criticality of spares Develop and assist in redlining and workflow process for SOP's relevant to the Facilities department Collaborate with peers to streamline or construct efficient Workflows/Business Practices Support of field walks, and general activities leading up to and at startup of systems; which includes but it is not limited to inspection field walks, punch list items generation, and inspection of equipment for Mechanical Completion Work with technicians and system owners to develop the scope of work, resource requirements, and parts requirements to complete preventive and corrective maintenance tasks in a safe, compliant, efficient, and effective manner Write clear, concise, and accurate Job Plan steps within the CMMS for corrective and preventive maintenance work orders Review turnover documentation and observe/document required spare parts for commissioning runs and future state operations Ensure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations. Collaborate with integrated facilities management team and craft groups to schedule maintenance activities as required to support site operations Support maintenance activities to allow efficient labor utilization of F&E crafts while minimizing the interruption to customer operations. Identify and coordinate contractor resources as needed to effectively complete tasks Overall Facilities Compliance: Owner for Facilities Standard Operating Procedures Responsible for reviews, updates and administration of SOP's for Facilities Department Owner of change controls - end to end process Owner of deviations and corrective actions Assist with Procurement and Invoicing for the department Provide technical support and issue resolution with 24x7 on-call support of Utility systems on a rotational based frequency (Support may be required outside of normal working hours including nights, weekends, and holidays). Data verification of GMP information for pest control compliance Delegate for Facilities Sr Manager during period of absence Day-to-day management of communication and any other tasks/projects assigned as per manager's request What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a collaborative partner with these qualifications. Basic Qualifications: High School Diploma / GED and 6 years of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR Associate's Degree and 4 years of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR Bachelor's Degree and 2 months of Work Order Administration, Mechanical Maintenance, Facilities/Utilities Operations, or Engineering experience OR Master's Degree Preferred Qualifications: Experience with regulated environments (i.e., cGMP, OSHA, EPA) including detailed understanding of current Good Manufacturing Practices Strong customer service skills, written and verbal communication skills, and the ability to work with minimal direction Demonstrated ability to function within cross-functional teams and embrace a team-based culture Ability to use Microsoft Excel, Word, PowerPoint, SharePoint, Smartsheet, and various database querying tools Good understanding of CMMS systems (Maximo, SAP, Blue Mountain, ETC.) Familiar with Root Cause Analysis and LEAN methodology Excellent facilitation, organizational and planning skills Proactive, self-starter with the ability to take on several projects at one time What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 94,978.00 USD - 114,953.00 USD
    $73k-95k yearly est. Auto-Apply 7d ago
  • Associate Scientist, Process Development (Process Validation & Business Strategy)

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryProcess DevelopmentJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in disposable technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Associate Scientist, Process Development (Process Validation & Business Strategy) What you will do Let's do this. Let's change the world. In this vital role you will be a part of the Process Development Drug Substance Technology group (PD DST) at Amgen's FleX Batch Biologics Manufacturing Facility. This position is part of the Process Validation & Business Strategy (PBS) team within PD DST. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes process development operation support, developing digital tools to support business processes, and support commercial development of Amgen's pipeline. The role will be responsible for ensuring PD business strategy operations have appropriate digital tools to track operational metrics for safety, training, compliance, support business processes improvements, and the commercial development of the Amgen's pipeline. In addition, the role will be responsible for supporting tech transfer activities as needed. Lead and develop the Process Development safety, training, and compliance monitoring operation Holistic Lab Execution Environment (HLEE) champion for the process development lab Develop digital tools to improve business process efficiencies and identify bottlenecks within the process development operation Develop digital tools to support process validation and process monitoring activities Support and develop the Amgen North Carolina (ANC) PD DST knowledge management ecosystem, alignment of ANC PD business process to network practice, and optimizing the ANC PD business process. Provide process floor or lab support as required What we expect of you We are all different, yet we all use our unique contributions to serve patients. The experienced scientific professional we seek is a leader with these qualifications. Basic Qualifications: Bachelor's degree and 3 years of Process Development or Scientific experience OR Master's degree and 1 years of Process Development or Scientific experience Preferred Qualifications: 2 - 4 years of experience in a Biotech/Pharma Process Development, MFG, QC, or laboratory role. Knowledge in broad aspects of biologics processing, for example cell culture, purification, analytical methods, or product quality attributes Familiarity in operational aspects of process development lab or commercial biopharma manufacturing Experienced with software such as Holistic Lab Execution Environment (HLEE), Tableau, MS PowerBI, spotfire, and/or databricks Able to apply digital tool skills to solve business process issues and evaluate opportunities for process improvements Excellent written and verbal communication Be a self-starter with the ability to take on several projects at one time. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 97,377.00 USD - 118,653.00 USD
    $57k-82k yearly est. Auto-Apply 12d ago
  • District Sales Manager - Oncology - Mid-Atlantic District

    Amgen Inc. 4.8company rating

    Raleigh, NC job

    District covers: Pennsylvania, Maryland, Virginia, Washington DC, West Virginia, Greensboro NC, Raleigh NC, Western NY 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. District Sales Manager - Oncology - Mid-Atlantic What you will do Let's do this. Let's change the world. In this vital role you will be the liaison to our customers by providing clinical knowledge of our products to medical professionals. Amgen's medicines treat serious illnesses and our research address diseases with a limited number of treatment options. With a robust and differentiated pipeline, Amgen remains committed to advancing science to dramatically improve people's lives. As a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients, we are actively searching for a District Sales Manager to deliver on this commitment to patients. 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. This position will require strong ability to collaborate cross-functionally with other Amgen business units including District Sales Mangers, Regional Sales Directors and Corporate Account Managers. Additional Responsibilities and Duties Include: * Track the progress of marketing messages and programs * Provide feedback to district teams on the marketing, allocating, monitoring, and leveraging of internal and external resources (e.g., discretionary spend) * Manage district teams to maximize their performance and help achieve/exceed sales and budget targets * Screen, interview, and hire candidates * Ensure compliance with training * Demonstrate the appropriate coaching and counseling to prepare individuals for future development * Conduct annual and on-going performance reviews and competency assessments * Communicate and coordinate with both district and cross-functional teams (e.g., Marketing, Finance, other Business Units) * Share best practices with direct reports and peers * Coordinate and/or participate in cluster teams * Conduct district sales meetings to guide districts * Develop local Opinion Leader relationships to achieve aligned objectives 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: Doctorate degree and 2 years of Sales/Marketing experience OR Master's degree and 6 years of Sales/Marketing experience OR Bachelor's degree or and 8 years of Sales/Marketing experience OR Associate's degree and 10 years of Sales/Marketing experience OR High school diploma / GED and 12 years of Sales/Marketing experience AND 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. Preferred Qualifications: * Three + years of specialty sales experience * Experience in oncology * Buy and bill model experience * Ability to consistently and objectively recognize and promote success behaviors, as well as diagnose and change unsatisfactory behaviors through effective coaching * Ability to leverage market & customer knowledge to strategically target messages, resources, and activities within the territory * Demonstrates knowledge of local payor coverage * Ability to understand and articulate clinical concepts, data, and conclusions * Demonstrated ability to utilize clinical information to effectively address customer questions and objections * Ability to recruit candidates that meet the minimum job criteria * Interviews and hires sales representatives that are capable and committed to fulfilling the job requirements * Strong sense of responsibility and demonstrated self-discipline * Setting appropriate short term and long term objectives; demonstrated success in communicating & collaborating with sales staff, peers, business unit counterparts in an effective and timely manner. 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 Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com 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 220,661.00 USD - 246,285.00 USD
    $96k-123k yearly est. 3d ago
  • Specialist Manufacturing: NPI, Process Owner

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryManufacturingJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Specialist Manufacturing: NPI, Process Owner What you will do Let's do this. Let's change the world. In this vital role you will communicate and interface between the GMP manufacturing teams in the Amgen North Carolina (ANC) Biologics Drug Substance Manufacturing plant and Process Development scientific groups. As part of ANC's Manufacturing Support team, this position is responsible for ensuring new products are successfully introduced into ANC's biologics manufacturing facility and ownership of downstream unit operations. It is a highly visible role across the site with the core responsibility of hosting cross-functional meetings to drive to timelines to support the tech transfer of the program into the facility as well as process ownership for some downstream process unit operations. New Product Introduction (NPI) lead coordinating with Manufacturing, Process Development, Supply Chain, Planning, Facilities and Engineering, as well as Quality to introduce new Drug Substance products and/or advanced technologies into the plant using project management tools (i.e. Smartsheet). Downstream biologics drug substance technical expert who leads or participates in projects, including aiding in commissioning and qualification and training staff on equipment and processes Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence. Owns New Product Introduction Change Controls and collaborates with stakeholders to drive on-time completion. Responds to regulatory questions and/or audit findings. Ensures that manufacturing production documents (e.g. Standard Operating Procedures) are accurate and up to date. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The manufacturing professional we seek has a biologics Drug Substance Downstream manufacturing background with strong cross-functional project management and communication skills as well as the below qualifications. Basic Qualifications: High school diploma / GED & 10 years of biotechnology operations experience OR Associate's degree & 8 years of biotechnology operations experience OR Bachelor's degree and 4 years of biotechnology operations experience OR Master's degree in chemistry, biology, or engineering & 2 years of biotechnology operations experience OR Doctorate degree Preferred Qualifications: Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry Excellent cross-functional project management, meeting facilitation, and technical writing skills Experience in Downstream GMP manufacturing operations Strong technical knowledge of drug substance processing (harvest, chromatography, filtration, buffer preparation) and a broad understanding of related disciplinary areas in bioprocessing. Ability to organize, analyze and interpret technical data through trend analysis, forecasting, modeling, etc. Ability to effectively communicate complex technical information with internal and external colleagues of varying organizational levels in both presentation and technical writing forms Ability to coach, mentor and/or cross train colleagues within core technical areas What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 112,977.00 USD - 139,179.00 USD
    $60k-82k yearly est. Auto-Apply 59d ago
  • Senior Instrument Technician

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryMaintenanceJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Instrumentation Technician What you will do Let's do this. Let's change the world. In this vital role, you will provide technical expertise and guidance supporting the start-up of the plant and daily operations. During Construction Phase: The initial focus of this role for the majority of 2024 will be to work closely with the Capital Project Delivery team providing technical support associated with the start-up, commissioning, and qualification of the wide variety of equipment and systems used in Manufacturing, Laboratories, Utilities, and other areas at the site. Support the implementation of the Metrology program meeting all Good Manufacturing Practices (GMPs) and safety requirements, local/ global regulations, and Amgen Maintenance excellence standards. Support the development, writing and implementation of the Metrology program documentation including Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc. Ensure safety of all staff during plant construction and start-up operations and metrology activities. Post-Construction completion and continued operations. In this key role within the Facilities & Engineering team, under limited supervision, the Senior Instrument Technician is responsible for: Performing calibration, repair, installation, troubleshooting and documentation / logs of instruments used on process control systems and building systems. Completing quality and safety documentation and completing the work in a safe, compliant, and timely manner according to planning and predefined schedules with minimal impact to production while aligning with GMPs, SOPs and Amgen policies and regulations. Work in a highly productive and efficient manner to maximize the quantity of activities completed with focus on maintenance excellence. Ensure work is appropriately communicated to system operators and key stakeholders. Ensure work order documentation is completed accurately. Reviewing and technically approving maintenance reports, forms, plans and records. Identify waste, work-flow interrupters, and other opportunities for improvement, recommend solutions, and assist with implementation. Identify opportunities to learn new skills and actively participate in development that will improve overall team performance. Represent Maintenance team in discussions and meetings with peers and other site functions. Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights, weekends and holidays. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The maintenance professional we seek is a dynamic team-player with these qualifications. Basic Qualifications: High school diploma / GED and 6 years of Maintenance experience OR Associate's degree and 4 years of Maintenance experience Preferred Qualifications: Experience in mechanical maintenance with an emphasis on sanitary processing equipment and systems. 3+ years knowledge of pneumatic, mechanical, and hydraulic systems and ability to effectively perform associated maintenance activities. Knowledge and experience working in a highly regulated function - cGMP. Experience executing and documenting maintenance work orders in a computerized maintenance management system. Ability to interpret P&ID's. Ability to work with minimum direction. Ability to effectively communicate issues and status of tasks in a timely manner. Ability to interact constructively with peers/teams. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 89,926.00 USD - 111,678.00 USD
    $89k-117k yearly est. Auto-Apply 7d ago
  • Network Architect - Manufacturing

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryInformation SystemsJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Specialist Network Engineer - Manufacturing What you will do Let's do this. Let's change the world. In this vital role you will lead the design, implementation, and optimization of industrial IO and IoT network infrastructure across our manufacturing sites. This role is pivotal to advancing our Industry 4.0 strategy, enabling scalable, secure, and intelligent connectivity for smart devices, sensors, and edge platforms. Key Responsibilities Architect and deploy robust IO and IoT network solutions for manufacturing environments, including edge-to-cloud integrations. Collaborate with cross-functional teams (OT, IT, DevOps, Engineering) to define requirements and deliver scalable network solutions. Develop and maintain documentation for network configurations, security policies, and deployment blueprints in line with Gartner's IoT Reference Model Provide technical leadership in troubleshooting, risk mitigation, and continuous improvement of network operations. Support IoT platform rollouts, including wireless sensor architecture and enterprise edge node deployments What we expect of you We are all different, yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications. Basic Qualifications: Doctorate degree OR Master's degree and 2 years of Computer Science, Electrical Engineering, or related field experience Or Bachelor's degree and 4 years of Computer Science, Electrical Engineering, or related field experience Or Associate's degree and 8 years of Computer Science, Electrical Engineering, or related field experience Or High school diploma / GED and 10 years of Computer Science, Electrical Engineering, or related field experience Preferred Qualifications: Strong expertise in industrial network architecture, standards governance, and multi-site rollout strategy. Hands-on experience with Rockwell Stratix switches, Cisco IE platforms, and configuration tools such as Studio 5000, Cisco Industrial Network Director, or equivalents. Proven ability to design and manage networks using PRP, DLR, and other redundancy and fault-tolerance protocols. Deep understanding of routing, switching, VLANs, and segmentation in mixed OT/IT environments. Familiarity with industrial protocols such as MQTT, OPC-UA, Modbus, and LoRaWAN. Practical knowledge of industrial cybersecurity principles, including ISA/IEC 62443, network zoning, access control, and anomaly detection. Experience in Layer 2/3 diagnostics, packet capture analysis, and bandwidth optimization within industrial networks. Ability to work in high-performance cross-functional teams and manage vendor engagements across global sites. Strong communication, collaboration, and documentation skills. What you can expect from us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. 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 118,665.00 USD - 145,594.00 USD
    $95k-119k yearly est. Auto-Apply 47d ago
  • Senior Medical Science Liaison- Autoantibody Pipeline-South

    Johnson & Johnson 4.7company rating

    Raleigh, NC job

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Medical Affairs Group Job Sub Function: Medical Science Liaison Job Category: Scientific/Technology All Job Posting Locations: Nashville, Tennessee, United States, Raleigh, North Carolina, United States Job Description: Johnson & Johnson Innovative Medicine is searching for the best talent for a Senior Medical Science Liaison- Autoantibody Pipeline for the South region. This is a field-based position located in the South region, the preferred location is the Raleigh, NC or Nashville, TN area. The territory covers Louisiana, Arkansas, Mississippi, Kentucky, Tennessee, North Carolina, South Carolina, and Virginia. About Immunology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine. The Senior Medical Science Liaison (Sr. MSL) is responsible for providing fair balanced, objective, scientific information and education to opinion leaders (OLs), health care professionals, and to internal partners as required by scientific and business needs. The Sr. MSL is considered an established scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per Therapeutic Area (TA) alignment. Sr. MSL is responsible for staying abreast of current scientific and treatment landscape trends in their therapeutic areas of interest. Sr. MSL provides research support for company and investigator-initiated research. The Sr MSL will function with high integrity and follow credo values. Sr. MSL is responsible for building external relationships with identified OLs and health care providers (MD, DO, PhD, PA, NP, RN, Pharm.D., bio coordinators) and developing and managing a geographical territory. These relationships and engagements can include both virtual & in-person, with a prioritization of in-person engagements when appropriate. The Sr. MSL is responsible for developing and maintaining a territory strategic plan, which includes educational activities with identified OLs, HCPs, institutions, and community practices. The Sr. MSL role is one that requires a level of competency and experience in the disease state. The Sr. MSL is expected to possess foundational competencies in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination. The Sr. MSL will be expected to rapidly identify and compliantly collaborate with field-based partners to ensure support of the Healthcare Providers, which will positively impact the patients that they care for. The Sr. MSL will continue to enhance their skills in agility, applying the competencies of Change Management, Time Management and Innovation. The Sr. MSL is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines. This is a field based clinical position which required travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 70%. Responsibilities: Consistently demonstrate strategic territory planning and ability to build strong relationships within the territory. * Responsible for developing and maintaining a field strategic plan. * Responds in a timely manner to unsolicited scientific inquiries of HCPs/investigators/health care systems/academic medical centers and population health decision makers integrating scientific data including real world evidence into real life practice to meet customer needs. * Presents data and information in a manner appropriate to the audience and request. * Execute plans regarding reactive and proactive outreaches as approved via the legal/HCC exceptions process. * Integrates scientific data into real life practice to meet customer/audience needs, adapting interpersonal style to particular situations and people. * Anticipates the responses of various individuals and teams based on their vantage point and perspective. * Prioritize franchise customer-based initiatives and field responsibilities, while balancing administrative duties and project responsibilities. * Executes Research Initiatives: * Leverages knowledge of standards of care and Janssen company/investigator sponsored clinical trials and competitor landscape to facilitate external-internal research communication. * Engages with external investigators regarding unsolicited research inquiries and act as liaison to R&D, Medical Affairs and operations teams. * Provides clinical trial support to identify potential sites, resolve issues with enrolled sites, and participate in meetings as appropriate, including site initiation visits and investigator launch meetings. * Effectively leads at least one scientific or strategic Immunology project, exhibits strategic identification of educational gaps and elevates team acumen. Consistently demonstrates strong scientific acumen. * Actively participate in team calls, trainings, & journal clubs through scientific dialogue, understanding of current standard of care, and regularly sharing of scientific news. * Attends and provides leadership at scientific conferences to gather and understand new scientific information relevant to the company and the external scientific community. * Medical insights: Actively listens for, documents, and shares medical insights. Proactively synthesize data and medical insights for MSL team and other partners * Sets aside time for self-driven learnings on current scientific landscape. * Role includes representing and supporting JNJ at relevant scientific or other key stakeholder meetings including congresses, symposia, advisory boards and investigator meetings. * Role includes representing JNJ at speaking engagements at relevant scientific or other key stakeholder meetings. Continuous support Department Operations and Internal Partners: * Performs all administrative requirements in a timely, accurate and compliant manner (e.g. expense reports, documentation of activities) * Maintain focus and composure in uncertain circumstances with minimal direction. * Provide regional and local support to enhance sales training initiatives and improve competencies of field personnel in partnership with Sales Learning and Development * Communicates and collaborates with all field-based partners, and other Immunology MSL teams on a routine basis. * Demonstrate the ability to partner with others to lead or participate in large scale projects. * Maintains thorough understanding and competence in the following areas (regulatory and health care compliance guidelines; corporate policies on appropriate business conduct and ethical behavior; Medical Affairs SOPs and guidelines. Qualifications Required: A PharmD, PhD, MD, w/ 3+ years relevant hematology, immunology and/or auto/alloimmune disease experience Minimum 3 years MSL experience, and/or 2-3 years relevant work exp (clinical or research experience) Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. Ability to travel up to 70 %. Preferred: Launch experience in rare disease is highly preferred. Significant experience giving presentations is highly preferred. Must be familiar with Microsoft Word, Excel, PowerPoint, and utilization of computers and remote technologies. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers and internal employees contact AskGS to be directed to your accommodation resource. #LI-Remote Required Skills: Preferred Skills: Analytics Dashboards, Clinical Research and Regulations, Clinical Trials, Consulting, Customer Centricity, Data-Driven Decision Making, Digital Culture, Digital Literacy, Medical Affairs, Medical Communications, Medical Compliance, Mentorship, Product Knowledge, Relationship Building, Research and Development, Strategic Thinking, Tactical Planning, Technical Credibility
    $90k-126k yearly est. Auto-Apply 6d ago
  • Senior Engineer - Project Engineering

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Engineer - Project Engineering What you will do Let's do this. Let's change the world. The Project Engineer is responsible for providing strategic leadership, technical oversight, and operational management for leading engineering and qualification of small project implementation. This role ensures compliant, efficient, and consistent validation practices across departmental capital projects, site initiatives, and ongoing system lifecycle activities. The position requires strong technical acumen, cross-functional collaboration, and the ability to drive both local and network-level improvements. Serve as Qualification Lead for departmental capital projects, overseeing contracted resources, documentation, CCMS assessments, and project alignment. Partner with project leads to scope new work, estimate efforts, and assign engineering resources. Manage the full lifecycle of the validation maintenance program, including development of the annual scope of work, cost negotiations, PO issuance, and leading progress meetings. Drive inspection readiness by maintaining playbooks, responding to inspection IRFs, and presenting qualification topics to auditors. Support construction and capital project teams by providing oversight as the role continues to expand. Lead efficiency improvements by developing automation/AI tools for periodic reviews and audit trail assessments. Participate in global qualification, computerized systems, and data integrity networks and share updates with site teams. May own and manage deviations as assigned. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The project engineer professional sought for this role will exemplify these values and possess the qualifications outlined below. Basic Qualifications: High school diploma / GED and 12 years of Project Implementation and Qualification experience OR Associate's degree and 10 years of Project Implementation and Qualification experience OR Bachelor's degree and 6 years of Project Implementation and Qualification experience OR Master's degree and 4 years of Project Implementation and Qualification experience OR Doctorate degree and 4 years of Project Implementation and Qualification experience Preferred Qualifications: Demonstrated leadership experience in managing technical teams or leading complex cross-functional initiatives. Strong understanding of GMP regulations, validation lifecycle requirements, data integrity principles, and qualification best practices. Experience serving as a project or qualification lead on capital projects. Ability to interface with auditors and respond to regulatory inspection requests. Familiarity with automated systems, CCMS/CMMS platforms, and AI/automation tools for compliance workflows. Excellent communication, stakeholder engagement, and decision-making skills. Ability to manage competing priorities in a dynamic environment and influence without authority. Strong analytical skills and ability to translate technical data into clear, actionable insights. Prior experience within the pharmaceutical, biotechnology, or regulated life sciences industry strongly desired. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team!careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 123,098.00 USD - 149,145.00 USD
    $83k-105k yearly est. Auto-Apply 10d ago
  • Sr Mgf Systems Engineer

    Amgen 4.8company rating

    Holly Springs, NC job

    Additional Information All your information will be kept confidential according to EEO guidelines.
    $85k-105k yearly est. 1d ago
  • Senior Engineer, Process Development (Downstream)

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Engineer, Process Development (Downstream) What you will do Let's do this. Let's change the world. In this vital role you will advance Amgen latest bioprocessing platform and technology, delivering high quality of medicine to patients around the world. The Sr. Engineer will be part of the Process Development-Drug Substance Technology at Amgen's FleX Batch facility, focusing on technology transfer, process support, and optimization. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network. Responsibilities include but are not limited to: Support technology transfer, process validation, and plant start-up Provide technical leadership in Downstream (Purification) Bioprocessing for process monitoring, optimization, yield improvement, complex investigation, and product life cycle management Partner with cross-functional teams to resolve complex problems while meeting quality, schedule, and cost objectives Provide on-the-floor process support as required Ensure safety and compliance of process development activities Collaborate with other site-functions and network drug substance teams in delivering plant goals Support regulatory filing, inspection, and other CMC activities What we expect of you We are all different, yet we all use our unique contributions to serve patients. The inspiring professional we seek is a strong team-player with these qualifications. Basic Qualifications: High school diploma / GED and 10 years of biologics process development or commercial-scale technical support experience OR Associate's degree and 8 years of biologics process development or commercial-scale technical support experience OR Bachelor's degree and 4 years of biologics process development or commercial-scale technical support experience OR Master's degree and 2 years of biologics process development or commercial-scale technical support experience OR Doctorate degree Preferred Qualifications: Master's degree in Engineering or Science discipline 5+ years of experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) In-depth expertise in biologics process purification processes Experience in process scale-up, technology transfer, process validation, process optimization, troubleshooting, and complex investigation Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders Able to apply engineering principles and statistical analysis in resolving complex issues Knowledge in regulatory filings and inspections Knowledge in broad aspect of biologics processing, for example cell culture, analytical methods, or product quality attributes Familiarity in operational aspects of commercial biopharma manufacturing (e.g. process automation, equipment, single use) What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 119,195.00 USD - 147,867.00 USD
    $88k-108k yearly est. Auto-Apply 60d+ ago
  • Manufacturing Procurement Site Lead

    Amgen 4.8company rating

    Holly Springs, NC job

    **Join Amgen's Mission of Serving Patients** At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manufacturing Procurement Site Lead **What you will do** Let's do this. Let's change the world. We are seeking an individual who thrives in ambiguity and is capable of driving procurement outcomes in a manufacturing operations environment with strategic vision and precision. In this vital role you will oversee the operations and management of manufacturing procurement at one of Amgen's world class global manufacturing sites. This position will play a key role in ensuring procurement deliverables support effective and efficient site-based manufacturing activities, while maintaining compliance with regulatory requirements, and driving continuous improvement in manufacturing operations. Reporting to the Manufacturing Site Lead within Internal & External Manufacturing, you will also act as the lead procurement business partner for the Site Head and their functional and cross-functional leadership team, connecting procurement outcomes to strategic business objectives at the site. **Roles & Responsibilities:** + Drive continuous improvement Procurement initiatives by identifying inefficiencies, recommending solutions, and implementing changes to enhance manufacturing performance, speed, and delivery. + Champion a multi-year pipeline of savings and value plans across the manufacturing site that alignment with category and business strategies delivered against Finance's annual budget plan + Be a trusted advisor across the Site Leadership Executive teams - ability to grow and maintain influence of Sourcing Agenda and delivered through strategic business partnership + Be a Procurement leader with strong financial competence, experienced with accountability to site Executives and cross-functional leaders + Lead with a commitment to continuous improvement in sourcing processes, tools and operating model; Develop goals and prioritize impact to site work among multiple initiatives; Courage to provide performance feedback across the category and sourcing teams + Connect the dots and translate central functional programs into site based deliverables and outcomes + Champion supplier relationship management for critical suppliers at the site level + Identify and mitigate supply risk while ensuring Procurement deliverables adhere to regulatory requirements (e.g., GLP, GMP, ISO) and implement quality control systems, including audits, inspections, and compliance-related activities. + Monitor and report on Procurement performance metrics, making necessary adjustments to meet organizational goals and identifying opportunities for cost savings and process improvements. + Evaluate and implement, through Procurement, process improvement, environmental sustainability, and automation initiatives to enhance operational efficiency and support long-term goals. + Maintain up-to-date knowledge of industry standards and best practices, sharing innovative procurement solutions within the global manufacturing operations network. **What we expect of you** We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications. **Basic Qualifications:** Doctorate degree and 2 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience **Or** Master's degree and 4 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience **Or** Bachelor's degree and 6 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience **Or** Associate's degree and 10 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience **Or** High school diploma / GED and 12 years of Procurement, Supply Chain, Manufacturing or Operations (preferably in a regulated industry) experience **Preferred Qualifications:** + In-depth knowledge of procurement best practices across manufacturing, capital, equipment, and technologies. + Familiarity with industry standards and regulations (e.g., GLP, GMP, ISO, OSHA). + Proven track record to drive value in a procurement environment supporting manufacturing + Strong analytical skills to monitor performance metrics, optimize procurement deliverables, and ensure compliance. **What you can expect of us** As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $145,239 to $170,803. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: + A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts + A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan + Stock-based long-term incentives + Award-winning time-off plans + Flexible work models, including remote and hybrid work arrangements, where possible **Apply now and make a lasting impact with the Amgen team.** **careers.amgen.com** In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. **Application deadline** Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. **Sponsorship** Sponsorship for this role is not guaranteed. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
    $145.2k-170.8k yearly 60d+ ago
  • Senior Manager Quality Assurance - Incoming Quality Raw Materials /Disposition

    Amgen 4.8company rating

    Holly Springs, NC job

    Career CategoryQualityJob Description Join Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Senior Manager Quality Assurance - Incoming Quality Assurance Raw Materials /Disposition What you will do Let's do this! Let's change the world! In this vital role, you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations. Specific responsibilities include but are not limited to: Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations). Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements. Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring. Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations. Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays. Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact. Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program. Represent the Quality unit during internal and external audits and regulatory inspections. Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed. Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline. What we expect of you We are all different, yet we all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong leader with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR Associate's degree and 10 years of Quality and Manufacturing support industry experience OR Bachelor's degree and 8 years of Quality and Manufacturing support industry experience OR Master's degree and 6 years of Quality and Manufacturing support industry experience OR Doctorate degree and 2 years of Quality and Manufacturing support industry experience Preferred Qualifications: Educational background in Life Science and/or Engineering Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems. In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice. Hands-on experience with Disposition, Incoming, and Quality Systems-particularly investigations, corrective actions, and audit readiness. Experience managing and interacting with regulatory and internal auditors. Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills. Effective risk management, negotiation, and cross-functional collaboration abilities. Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models, including remote and hybrid work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 154,692.00 USD - 188,725.00 USD
    $102k-132k yearly est. Auto-Apply 12d ago

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