Amgen jobs in Holly Springs, NC - 126 jobs

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 -

United States - North Carolina - Raleigh Medical Affairs Regular Lead the implementation of a portfolio of technologies and platforms that enable business process and decision making. Establishes and maintains the roadmap for your assigned portfolio by leading the internal idea generation, external benchmarking, and technical evaluation process. Work collaboratively with the Medical Affairs, Medical Excellence, Medical Governance, and other Medical Affairs Technology leads to help generate meaningful business requirements and design technical solutions that meet those requirements. Support technology tool maturity by refining processes, delivery templates, and tools with key regional stakeholders based on business needs. Provide portfolio and project level leadership by managing scope, timelines, communication, testing, and risks associated with the assigned portfolio. Lead technology implementations with aggressive timelines, broad scope, and high impact according to established business needs while reporting on the project status and budget to the Executive Director of Medical Affairs Technology. Be the primary source of education and inspiration about ways to leverage technology solutions by being the expert in your assigned platforms and defining new ways it can accelerate Medical Affairs outcomes. Balance the needs of the platform (performance, scalability, cost, data integrity) with the requests of the business (new functionality, speed to market, integrations) during roadmap planning and while advising on solution design. Develop creative and effective solutions to address inter- and intra-project priority conflicts, resource constraints and other problems which may impact project goals and deliverables across multiple programs. Establish and maintain cross-functional communication channels, work practices and processes with internal stakeholders relevant to accomplishing business outcomes. Advise and/or participate in cross-functional governance, standards and SOPs for global MA technology tools and capabilities. Balance long-term vision with short-term delivery while making decisions to invest/build/sustain to catalyze the organization to deliver on the business outcomes. Basic Qualifications BA/BS and 10 + years of business experience in CRM, Analytics or Technology modernization and LEAN methodology delivery practices OR MA/MS and 8 + years of business experience in CRM, Analytics or Technology modernization and LEAN methodology delivery practices Preferred Qualifications and Strongly Desired A strong background in Information Technology - ideally a degree or formal training in IT systems, data platforms, or digital tools. Additional certifications in Veeva, Salesforce, or Business Process Automation 3 - 5 years global/in-market Pharma/Biopharma experience preferable Experience implementing or upgrading to modern technology platforms inclusive of AI integration/utilization. Demonstrated practical and technical experience in business case development, planning, implementation, operation, and management of digital and mobile initiatives. Proven experience articulating and advising on the strategic value of new technology, digital, or operational solutions Experience shaping end to end field experience delivering creative and simple solutions to complex problems Excellent communication skills, including the ability to break down complex structures and ideas into consumable concepts for a diverse set of stakeholders, from entry to expert level Demonstrated excellence in developing effective creative solutions to complex problems Demonstrated excellence in delivering skilled communications around change management that build system adherence Demonstrated excellence in building and maintaining relationships with senior leaders Highly organized with a strong attention to detail, clarity, accuracy, and conciseness Uncompromising ethical standard and conduct Able to motivate and foster cross-functional collaboration People Leader Accountabilities Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. #J-18808-Ljbffr

** Pharma Technical Manufacturing (PTM) is responsible for managing all aspects of end-to-end drug substance and drug product manufacturing and supply. From the raw material to the final medicine, we contribute to deliver Roche's ground-breaking therapies to more than 120 million patients around the world. We make our medicines at 9 sites around the world and coordinate all aspects of production of Roche medicines in all disease areas and dosage forms. To ensure readiness for a step-change in the standard of care that Roche delivers in the area of Cardiovascular, Renal and Metabolism (CVRM), PTM will construct a new manufacturing site in the U.S. in Holly Spring, North Carolina. The new site will focus on large volume low cost Drug Product manufacturing (Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products). **The Opportunity** We're looking for a highly skilled Master Production Scheduler/Senior Production Scheduler to join our team. In this role, you'll be responsible for developing and maintaining the master production schedule, ensuring we meet customer demand while optimizing our production resources. You'll be a key player in our supply chain, bridging the gap between sales, operations, and procurement. As part of plant start-up you will act as the Materials Management PLAN main functional contact for the SAP ERP deployment; responsible for the timeline, deliverables, and adherence to the global template processes. Initially, you will perform a mix of remote and onsite work (first at the General Planner's office, later at construction site/plant). You will transition to local full time on-site work once the site buildings are built and equipment delivered. Travel of up to 30% of the time is expected during the project phase. + You will create and maintain a feasible Master Production Schedule (MPS) for key finished goods and components, balancing customer demand with production capacity. Use inputs from the sales forecast, customer orders, and inventory targets to drive the schedule. + You will assess and manage production capacity, identifying and resolving any bottlenecks. Work closely with production managers to ensure the MPS is achievable. + You will partner with the procurement team to ensure timely availability of raw materials and components needed for production. Monitor inventory levels and adjust the MPS as needed to prevent stockouts or excessive inventory. + You will utilize SAP S/4HANA for planning and execution, and OMP for advanced planning and scheduling. You'll need to be proficient in these systems, generating reports, analyzing data, and making informed decisions. + You will serve as the primary liaison between sales, operations, finance, and procurement. You'll communicate changes to the schedule, manage expectations, and facilitate a smooth production flow. + You will monitor and report on key performance indicators (KPIs) such as production attainment, schedule adherence, and inventory accuracy. Use this data to identify areas for continuous improvement. + You will apply standard APICS (Association for Supply Chain Management) principles and best practices in all aspects of master scheduling. A strong understanding of planning, scheduling, and inventory management concepts is essential. + You will lead site function activities for SAP deployment fit-to-template, design, test, SOP development, go-live, and hypercare **Who You Are** You hold a Bachelor's degree in Supply Chain Management, Operations, Business, or a related field with 8-10 years in a master production scheduler or similar supply chain planning role.. + You have proven experience with ERP planning processes and software (eg. SAP S/4HANA and OMP) is required. + You have strong analytical and problem-solving abilities, with the capacity to analyze complex data and make data-driven decisions. + You have excellent communication and interpersonal skills, with the ability to effectively collaborate with various teams and stakeholders. Preferred + You have a CPIM (Certified in Planning and Inventory Management) or CSCP (Certified Supply Chain Professional) certification + You have an advanced degree (eg. Masters, MBA) + You have experience with the implementation of large scale ERP projects a plus The expected salary range for this position based on the primary location for this position of Holly Springs, North Carolina $91,070 - $169,130. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Relocation benefits are provided. Link to Benefits (**************************************************** Relocation benefits are provided Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants (***************************************************************************************************** .

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

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution · Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity This position is a field-based position based in Fayetteville, NC in the Cardiac Rhythm Management division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats. What You'll Work On Under general direction, the CRM Product Support Specialist provides comprehensive engineering, sales, educational, and technical support. This role responds to field inquiries from physicians, healthcare professionals, patients, and field sales staff regarding CRM (Cardiac Rhythm Management) products. Key Responsibilities: Clinical Interface: Acts as a senior clinical interface between the medical community and the business. Relationship Building: Demonstrates the ability to build and sustain credible business relationships with customers and share product expertise accordingly. Comprehensive Support: Provides engineering, sales, education, and clinical support in response to field inquiries on an as-needed basis. Demonstrates a thorough command of all CRM products, related product and technical knowledge, trends, and players while providing regional case coverage. Training and Education: Develops, leads, and/or facilitates training sessions and other programs on CRM products for healthcare professionals. Sales Support: Provides additional back-up support to Cardiac Rhythm Team in the following areas: Sales support Regional training seminars Clinical studies/data collection Trouble Shooting New product in-service training to physicians, nurses and sales representatives Mentors and provides leadership for less experienced Clinical Specialists Continuously develops engineering, sales and technical skills relative to the overall Arrhythmia Management strategy, including learning opportunities via Sr. Sales personnel and management. Required Qualifications Bachelor's degree in Bio-Medical Engineering, related field or equivalent healthcare experience. 4+ years of related experience or a program certification from an accredited cardiac training program. Must have certifications in CRM products. Demonstrated knowledge of cardiology, electro-physiology, or cardiac electro-physiology procedures. Familiarity with cath lab and operating room procedures and protocol Demonstrate advanced knowledge of cardiac pacing systems. Must apply engineering skills and abilities to interpret and solve complex clinical problems. Must possess strong written and verbal communication skills, along with excellent interpersonal, presentation, analytical, and organizational abilities. Additionally, must be able to meet deadlines effectively. Must be detail-oriented and capable of working independently. Must be able to collaborate effectively with engineers, technical specialists, vendors, and customers to achieve assigned goals. Additionally, must be capable of managing multiple assignments simultaneously and efficiently. Must have extensive personal computer skills, including experience with Microsoft Office or equivalent software, for tasks such as graphics, word processing, databases, and authoring programs, to develop presentation materials. Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at *********************** and on Twitter @AbbottNews. The base pay for this position is $78,000.00 - $156,000.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Support ServicesDIVISION:CRM Cardiac Rhythm ManagementLOCATION:United States of America : RemoteADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 50 % of the TimeMEDICAL SURVEILLANCE:NoSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Driving a personal auto or company car or truck, or a powered piece of material handling equipment Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************

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

Career 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. Sr 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! During Construction Phase: System Owner responsibilities for facilities and utilities infrastructure systems including Building Shell & Core, Fire Protection & Suppression, Fire Alarm, Domestic Water, Sewer, etc. 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 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 Post-Construction Completion and Continued Operations: System Owner responsibilities for key facilities and utilities systems including, but not limited to: Building Shell & Core, Fire Protection & Suppression, Domestic Water, Sewer, etc. 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 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 Assist with Procurement and Invoicing for the department 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 -

**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. **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.

Our Sales team support our customers by providing clinical information about products, educational information, clinical training programs and resources. We support healthcare providers and healthcare systems meet the goals of the patients in their communities. Our Company's Oncology organization is dedicated to delivering breakthrough innovations that extend and improve the lives of cancer patients worldwide. Our team of dauntless, forward-thinking individuals achieves this through an unwavering commitment to supporting accessibility to medicine, providing new therapeutic procedures, and collaborating with governments and payers to ensure that people who need medicines have access to them. At our company, our focus is on innovation and launch execution excellence; we translate breakthrough science into innovative medicines that help people with cancer across the globe. As we continue to grow and define the Oncology market of the future, we are looking for dynamic, entrepreneurial individuals who thrive in a team environment and are driven to succeed. The Oncology Sales Specialist is a key member of our customer facing organization and is responsible for partnering with customers to address identified needs, educating key stakeholders about our leading immunotherapy compound, and communicating our vision to the larger Oncology community. + This is a field-based sales position that will cover the **South Orange County, California.** + The selected candidate must reside within the territory. + Overnight travel may be required about 25% of the time. + Travel (%) varies based on candidate's location within the geography. **General Responsibilities:** + Demonstrate in-depth knowledge of how to create a compelling and logical rationale for the value of products and how to contrast, compare, and position our company brand(s) versus competition using appropriate resources in informed discussions about products with HCP customers - knowing when/how to seek and provide additional information + Act as primary point of contact for customer. Meet with key customers/personnel to understand practice structure, business model, and key influencers. + Possess knowledge of cancer staging and possible treatment options and dosing schedules associated with different tumors/diseases, with comprehensive understanding of the impact of those options on the patient. Must understand impact and use of clinical trials in multiple tumor types/therapies, both in impact on promoted products and in practice behavior of the account. + Ability to analyze and identify trends in a complex buying environment. This includes the multiple channels of drug distribution, Oncology GPO's, wholesalers and specialty pharmacies. Review and evaluate patterns for products purchased and prescribed, outpatient vs in-patient infusion, as part of hospital contract, etc. + Demonstrate ability to understand complex account interdependencies in order to develop both short- and long-term account plans in conjunction with a wide array of stakeholders, proactively working with the account team and supervisor (known as the Customer Team Leader) to effectively execute the account plan. Share learnings and best-practices from one customer to help other customers meet their needs. + Influence beyond their specific geography or product area demonstrate advanced ability to ask strategic, insightful questions to obtain information on customer needs from all stakeholders in oncology accounts, using the insights to position our company Oncology brands and collaborate with customers on a customized strategy. + Collaborate and communicate effectively with extended "in-scope" customer team to ensure a consistent customer experience across our company's divisions and functional areas; ensure integration with the Key Account Manager, Nurse Educator, Field Reimbursement Associate, Medicare Account Executive, and other key stakeholders to share key customer learnings and support customer needs. **Position Qualifications** **:** **Minimum Requirements:** + Bachelor's degree with 6-8 years Sales experience OR a minimum of high school diploma with at least 10 years of equivalent experience + Equivalent experience can be: Professional sales experience, work experience in the healthcare/scientific field (including pharmaceutical, biotech, or medical devices) that is not sales related, professional marketing experience, or military experience + 2+ years of oncology field sales experience + Valid driver's license and ability to drive a motor vehicle + Travel the amount of time the role requires **Preferred Experience and Skills:** + Documented history of strong performance in a sales / marketing or oncology clinical role + Clinical oncology experience across multiple solid tumors (Women's cancer - Breast, Ovarian, and Cervical) + Candidates with 0 - 2 years of oncology field sales experience will be hired at the S2 Oncology Sales Representative level. + Candidates with 2+ years of oncology field sales experience will be hired at the S3 Oncology Sales Specialist level. oncosales **Required Skills:** Account Management, Account Management, Account Planning, Adaptability, Biodesign, Biopharmaceutical Industry, Cancer Diagnosis, Clinical Experience, Customer-Focused, Customer Handling, Customer Relationship Management (CRM), Customer Service, Healthcare Sales, Interpersonal Relationships, IS Audit, Lead Generation, Lead Generation Management, Market Analysis, Medical Devices, Oncology Nursing, Oncology Sales, Pharmaceutical Management, Pharmacology, Product Knowledge, Proven Commitment {+ 5 more} **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $156,900.00 - $247,000.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Remote **Shift:** Not Indicated **Valid Driving License:** Yes **Hazardous Material(s):** N/A **Job Posting End Date:** 01/18/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R381204

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world's most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. Director, Clinical Data Science - SAS Macro and Data Operations leads the end-to-end strategy, development, qualification, and lifecycle management of Statistical Programming tools, macro libraries, applications and automation solutions that accelerate clinical analysis and reporting. The role owns a multi-disciplinary team spanning statistical programming, data engineering, and platform operations, and partners closely with Biostatistics, Clinical Operations, Regulatory, and Quality to ensure compliant, efficient, and scalable delivery. Core technologies include SAS Macros, Python, Linux scripting, and modern cloud services. Key Responsibilities: Strategic Leadership & Team Management * Lead, mentor, and develop a team of SAS macro programmers, data engineers, and application developers (including Linux scripting, Python console, and web applications) to deliver high-quality statistical programming solutions for clinical trials and regulatory submissions. * Set clear goals, conduct performance assessments, and foster professional growth and continuous learning within the team. Programming Oversight & Technical Excellence * Oversee the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs). * Ensure programming infrastructure is robust, scalable, and compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility and audit readiness. * Promote automation and standardization of programming workflows to improve efficiency and consistency across studies. Project Delivery & Resource Management * Accountable for the timely and quality completion of all programming deliverables across assigned projects and studies, including resource allocation and prioritization. * Manage project timelines, budgets, and external vendor relationships as needed. Cross-Functional Collaboration * Collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define programming requirements, align on analysis/reporting deliverables, and ensure data integrity. * Represent the statistical programming function in cross-functional meetings and strategic initiatives. Process Optimization & Innovation * Lead the development and implementation of programming standards, best practices, and innovative solutions (including cloud-based platforms, AI/ML, and automation pipelines) to enhance efficiency and quality. * Evaluate and integrate emerging technologies into statistical programming workflows. Compliance, Documentation & Quality Assurance * Ensure all programming activities adhere to SOPs, regulatory requirements, and internal quality standards; maintain audit readiness and documentation for all deliverables. * Oversee code quality, version control, and documentation governance frameworks. Stakeholder Engagement & Training * Provide technical guidance and training on advanced programming techniques, tools, and industry trends to team members and stakeholders. * Act as a key point of contact for external vendors and partners, ensuring alignment on programming standards and deliverables. Basic Qualifications PhD / PharmD and 8 years of experience OR Master's and 10 years of experience OR Bachelor's and 12 years of experience Preferred Qualifications: * Education: BS/MS/PhD in Biostatistics, Computer Science, or related field; advanced degree preferred. * Technical Skills: Expert in SAS Macros and strong proficiency in Python; working knowledge of R and Linux scripting; familiarity with AWS Cloud. * Core Competencies: Strategic thinking, cross-functional influence, compliance mindset, talent development, user-centric engineering. People Leader Accountabilities: * Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. * Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. * Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: Bay Area: $210,375.00 - $272,250.00. Raleigh: $181,730.00 - $235,180.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

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

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Company Overview: At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide increased technical capacity across the network. Position Brand Description: The Director/Senior Director, Global Process Owner for Sterility Assurance, as a leader within the Technical Service, Manufacturing Sciences, Sterility Assurance team, will establish and maintain the global quality system procedural requirements for a Level 2 Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic Technique, and Aseptic Training. They will provide strategic oversight and expertise for global Aseptic Processing Programs, including Quality Management System Sterility Assurance standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead an Aseptic Processing Program Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Sterility Assurance Level 1 Program. The Global Process Owner will consult with Lilly manufacturing facilities, Global and Site Quality and other functions to educate on the Sterility Assurance program requirements, and proactively ensure compliance of the Lilly Sterility Assurance program with various country agency standards, industry trends and scientific principles. Key Objectives/Deliverables The Director/Senior Director, Global Process Owner for Sterility Assurance Level 2 Processes is responsible to: * Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally. * Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations. * Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset. * Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. * Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics. * Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance. * Monitor performance metrics, report and provide insights to inform decision making to drive further improvements. * Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools. * Actively collaborate with enterprise-wide teams on standardized global business processes. * As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed. * Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management. * Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique Basic Requirements: * 10+ years' experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing * 7+ years' experience in parenteral manufacturing sterility assurance control systems - development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment. * Bachelor's degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field. * Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management. * Strong technical understanding of sterility assurance, from a science and compliance perspective. Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation) * Strong written and oral communication skills * Understanding of cGMP's, policies, procedures, and guidelines relating to sterility assurance * Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals * Approximately 25% travel Additional Preferences: * Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control. * Experience leading a major multi-site or global functions improvement initiative. * Strong strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities. * Proficiency in addressing operational challenges through structured approaches and innovative solutions. * Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data. * Demonstrated change agility in anticipating and leading others through change and ambiguity. * Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats. * Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity. * Demonstrated influential leadership expertise and experience engaging with senior-level functional leads. * Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results. * Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks. * Demonstrated people management experience. * Expertise in navigating and ensuring adherence to global regulatory standards and frameworks. * Experience leading a major multisite improvement initiative or driving multisite standardization. * Prior demonstrated experience managing aseptic processing programs including global procedural requirements and training. * Work closely with senior technical staff in the parenteral network TSMS group to provide full oversight to new and existing facilities. Be available to help with inspection readiness and inspection preparation at each site, particularly the new sites. Provide guidance to investigations and ensure root cause, CAPA are quickly developed. * Support the establishment of a sterility assurance network or hub in global TSMS * Support inspection preparation and execution during health authority on-site or remote inspection as an expert in Sterility Assurance Education Requirements: BS/MS in a biological science (or equivalent work experience) or engineering discipline (Microbiology-preferred, Biology, Chemistry, Mechanical Engineering, Biomedical Engineering, etc.), preferably Microbiology. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $264,000 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

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

Use Your Power for Purpose Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need. What You Will Achieve In this role, you will: Oversee the production of drug substances or active biological ingredients (ABI), ensuring targets are met and processes remain consistent. Manage quality, compliance, and customer service, including staffing and employee counseling. Ensure team performance is accurate, timely, efficient, and compliant with corporate policies, SOPs, GMPs, and other regulations. Optimize resources to maximize production while maintaining quality and safety standards. Lead and coach production work teams, manage technical resources, and solve complex problems within your expertise. Establish operational activities supporting mid-term goals, recognize development needs, and create opportunities for colleagues. Coordinate activities for equipment and automation changes, participate in daily manufacturing activities, and ensure a safe work environment while collaborating with functional SMEs and trainers to meet production goals and training needs. Here Is What You Need (Minimum Requirements) High school diploma (or equivalent) with 8+ years of experience or associate's degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience Strong people management skills Ability to identify, evaluate, and correct potential hazards in the workplace Experience in pharmaceutical manufacturing or a related field Knowledge of current Good Manufacturing Practices (cGMP) Proficiency in managing quality, compliance, and customer service Strong problem-solving skills and the ability to manage complex projects Bonus Points If You Have (Preferred Requirements) General knowledge of scientific principles Experience with production equipment and related procedures Experience in process improvement and innovation Ability to work collaboratively with cross-functional teams Strong analytical and decision-making skills Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use Other job details Last day to apply: January 21st, 2026 Work Location Assignment: On Premise The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make ********************** accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Manufacturing

The Quality Associate Director/GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing the full scope of site operations. Collaboration is required with site leadership, regional compliance leadership and Divisional Quality Assurance to elevate site audit program to achieve excellence and ensure program is effective. The position requires ability to lead and perform the operational aspects of the audit program, apply risk-based principles, communicate results to stakeholders, and evaluate/verify CAPA closure. Position requires risk communication related to the totality of audit and inspection findings at the site. Ability to lead an audit program that is focused on early detection and robust remediation of observation across the site. Ability to play a lead role in hosting Health Authority inspections and Divisional Audits at the site. Position Responsibilities: Actively manage, mentor, and support site auditors to ensure performance of auditors contributes to the effectiveness of the site audit program Function as a change agent related to culture and audit program performance Lead change and process improvement initiatives related to Auditing, Inspections, CAPA, and other compliance topics Perform routine risk communication pertaining to audits/inspection to Site, Regional, and Divisional Management Mentor new auditors to ensure comprehensive training and full understanding of auditor roles and responsibilities Achieve and maintain auditor qualification status through robust training and continuing education Lead training/orientation for new Quality Auditing staff Ensure preparation of annual audit schedule, using risk-based approaches Schedule and perform assigned audits for site program. Ensure timelines and quality of content for audit execution (audit pre-work, conducting audit, issuance of audit report, CAPA review and verification) meet established expectations. Perform, lead, and mentor other auditors during site audits; participate in opportunities to audit at regional sites Review, and approve Audit Reports Actively monitor, report and trend observations/CAPAs, along with standard site audit metrics to Quality Council and Management Actively participate and take a leadership role in the Auditor Community of Practice and Guest Auditor Program Review and ensure CAPA responses to Audits and Inspections are robust Perform a risk-based verification and effectiveness check on key CAPAs from audits and inspections Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards Lead company and site preparation activities for support of regulatory and customer inspections Provide compliance advice to site, development and commercial product teams Supports and continually enhance the ongoing site Permanent Inspection Readiness status Obtain and maintain cutting-edge knowledge and auditing techniques across applicable technical/Quality topics Education Minimum Requirement: Bachelor's degree in engineering, Biology, Chemistry or related field Required Experience and Skills: Minimum of five (5) years of manufacturing, technology, laboratory, and/or quality operations experience within GMP environment GMP Compliance knowledge and proficiency in interpreting and applying domestic and international regulatory requirements Knowledge of Quality Systems within a GMP environment Demonstrated ability to establish and maintain collaborative relationships with key stakeholders Ability to work independently with limited supervision Ability to build relationships and influence across disciplines and all levels Preferred Experience and Skills: GMP Audit experience in the pharmaceutical industry (CQA or other certification preferred) Experience with leading effective audits and obtaining meaningful audit observations “Subject Matter Expertise”, including knowledge and demonstrated application in one or more of the following areas, based on site activities; Medical Device/Combination products, Biologics, Vaccines, API's or Non Sterile or Sterile Drug Product Specific technical knowledge in areas pertaining to the hiring site (e.g, Quality Systems, Manufacturing, Testing/Stability, Microbiology testing, Packaging, Distribution, Data Integrity, Automation) Knowledge of QBD development & submission requirements, as applicable to site Ability to lead, motivate, develop and mentor other auditors Knowledge of and experience in Quality Risk Management methods Knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements, as applicable Experience with hosting or participating in Health Authority inspections and/or Divisional audits Highly motivated, flexible, and have excellent organizational and communication skills Excellent verbal and written communication skills Ability to prioritize and balance work from multiple projects in parallel Required Skills: Accountability, Accountability, Aseptic Processing, Audit Management, Biological Sciences, cGMP Training, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, GMP Compliance, Immunochemistry, Internal Auditing, IS Audit, Management Process, Medical Devices, Molecular Microbiology, Quality Auditing, Quality Control Documentation, Quality Control Management, Quality Management Systems (QMS), Quality Metrics, Quality Risk Assessment, Quality Risk Management, Regulatory Compliance Consulting {+ 5 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $126,500.00 - $199,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/20/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

**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 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.

Career CategoryEngineeringJob DescriptionJoin Amgen's Mission of Serving Patients At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX batch facility will combine the latest in single use technologies with traditional stainless steel equipment to allow for maximum flexibility in operations The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Engineering - Project Manager What you will do Let's do this. Let's change the world. This role is responsible for the strategic planning, implementation, and oversight of complex, high-impact facilities projects. The individual will ensure that all initiatives are completed on schedule, within budget, and in alignment with organizational standards for safety, quality, and operational excellence. The position requires strong leadership, technical expertise, and the ability to drive multi-functional collaboration to deliver projects that support Amgen's mission to change the world through innovation and excellence. Lead and oversee the execution of multiple facilities engineering projects from initiation through completion, ensuring alignment with organizational goals and objectives. Develop comprehensive project plans, including scope definition, timelines, budgets, and resource allocation strategies. Coordinate and collaborate with internal stakeholders, external contractors, and consultants to ensure all project requirements, specifications, and deliverables are met. Provide leadership and direction to multi-functional project teams, encouraging accountability, technical excellence, and effective communication. Monitoring and evaluating project performance, identifying risks and implementing corrective actions to maintain schedule and budget adherence. Ensure all projects align with applicable regulatory requirements, industry codes, and company standards for safety and quality. Prepare, maintain, and present detailed project reports, status updates, and performance metrics to senior management and key collaborators. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The project management professional sought for this role will exemplify these values and possess the qualifications outlined below. Basic Qualifications: High school diploma / GED and 10 years of engineering project management experience OR Associate's degree and 8 years of engineering project management experience OR Bachelor's degree and 4 years of engineering project management experience OR Master's degree and 2 years of engineering project management experience OR Doctorate degree Preferred Qualifications: Demonstrated success in managing and delivering complex, large-scale projects within scope, schedule, and budget parameters. Leadership and team management capabilities, with the ability to empower and guide cross-functional teams toward successful outcomes. Exceptional communication, presentation, and interpersonal skills, with a focus on collaboration and stakeholder engagement. Strong ability to perform effectively under pressure, manage challenging priorities, and meet tight deadlines. Proficiency in project management methodologies, software, and analytical tools. Project Management Professional (PMP) certification or equivalent credential preferred. Prior experience within the pharmaceutical, biotechnology, or regulated life sciences industry strongly desired. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team!careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary Range 122,112.00 USD - 147,362.00 USD

Additional Information All your information will be kept confidential according to EEO guidelines.

**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. The Amgen FleX batch facility combines the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility not only features the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities but also integrates sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. **Associate Engineer, Process Development** **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 at Amgen's FleX Batch Biologics Manufacturing Facility. 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. Additionally, the Process Development Associate will use out-of-the-box thinking to contribute to technology development and will demonstrate the desire to expand and develop expertise in downstream protein purification, thereby further contributing to the integrated group. + Apply a fundamental understanding of Downstream (Purification) Bioprocessing to support biologics technology transfer, process validation, and plant start-up + Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management + Ensure safety and compliance of process development activities + Provide process on floor process support as required + Provide support for 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 scientific professional we seek is a leader with these qualifications. **Basic Qualifications:** + High school diploma / GED and 6 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR + Associates and 4 years of Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences' experience OR + Bachelor's degree **Preferred Qualifications:** + Master's degree in Chemical, Biomedical, or related Engineering; Life Sciences; or other relevant sciences + Some experience in a technical role supporting biotechnology processes within regulated environments (i.e., cGMP) + Understanding of protein purification/separation principles + Understanding of process scale-up, technology transfer, troubleshooting, and complex investigation + Strong oral and verbal communication skills, interact effectively with diverse internal and external stakeholders + Familiarity in statistical analysis, analytical methods, and product quality attributes related to biological processing **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.