Associate Manufacturing - Bulk Drug Substance - Services - Day Shift
Holly Springs, North Carolina, United States · On-site
$71k–$96k/yr
Mid level$29B raised
Career CategoryManufacturingJob Description Join Amgen’s Mission of Serving Patients Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therap…
Skills: cGMP, Aseptic Techniques, Buffer And Media Preparation, Electronic Batch Records, Equipment Sanitization
Career CategoryQualityJob Description Help shape the future of quality at Amgen. At Amgen, every step we take is driven by a powerful mission—to serve patients. As one of the world’s leading biotechnology companies, we a…
Career CategoryEngineeringJob Description ABOUT THE ROLE We are seeking a Data Scientist, Forecasting to join the Forecasting team within the AI & Data organization. This role will support the development of statistical,…
Career CategorySalesJob Description West District Covers: Los Angeles, Seattle, San Francisco, Phoenix and Dallas geography Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something big…
Senior Oncology Specialist - Sapphire - Boston, MA
Boston, Massachusetts, United States · Hybrid
$140k–$190k/yr
Mid level$29B raised
Career CategorySalesJob Description Territory covers Boston, Cambridge, Lawrence, Watertown Relocation not provided for this role Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of somethi…
Lexington-Fayette, Kentucky, United States · Remote OK
$158k–$222k/yr
Senior$29B raised
Career CategoryCorporate ServicesJob Description Must live in Kentucky 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 serv…
Career CategoryClinical DevelopmentJob 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 wi…
Skills: Clinical Data Management, Database Build Testing, Data Cleaning, Query Management, Reconciliation
Career CategoryLaw/LegalJob Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is …
Career CategoryEngineeringJob Description ABOUT THE ROLE We are seeking a Senior Data Scientist, Forecasting to join the Forecasting team, within the AI & Data organization. This role will develop advanced statistical, B…
Career CategoryEngineeringJob Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, ma…
Career CategoryEngineeringJob Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, ma…
Career CategoryEngineeringJob Description ABOUT AMGEN Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, ma…
Skills: Data Science Strategy, Forecasting, People Leadership, Machine Learning, AI Governance
Career CategoryFinanceJob 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 il…
Skills: Financial Reporting, Budgeting, Forecasting, Variance Analysis, Standard Costing
Thousand Oaks, California, United States · On-site
$126k–$171k/yr
Senior$29B raised
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 …
Skills: Oral Solid Dosage Formulation, Process Development, Drug Product Strategy, Hot Melt Extrusion, Spray Dried Dispersions
Bogota, Capital District, RAP (Especial) Central, Colombia · Hybrid
Mid level$29B raised
Career CategorySales & Marketing OperationsJob 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 l…
Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance
Thousand Oaks, California, United States · Remote OK
$143k–$193k/yr
Senior$29B raised
Career CategoryRegulatoryJob 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 …
Skills: Regulatory Promotion, Material Compliance, FDA Regulatory Environment, Promotional Review Committee, Negotiation
Career CategoryInformation SystemsJob Description Role Summary: The Scrum Master is an agile coach responsible for enabling CDT/GRC teams to deliver high-quality outcomes through Agile execution, continuous improvement, …
Engineer - F&E Environmental & Contamination Control
West Greenwich, Rhode Island, United States · On-site
$88k–$119k/yr
Mid level$29B raised
Career CategoryOperationsJob 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…
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 wit…
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$71k–$96k/yr
Full-time
high school, associate degree, bachelor degree, professional certificate
Retirement And Savings Plan, Group Medical Insurance, Dental Insurance, Vision Insurance, Life Insurance, Disability Insurance
Posted 47d ago
~36 hrs/week
Responsibilities
Perform hands-on manufacturing operations for cGMP drug substances, including equipment setup, cleaning, and monitoring. Responsible for buffer and media preparation, in-process sampling, and maintaining accurate electronic batch records.
Requirements
Requires a High School diploma with 2 years of regulated experience, an Associate's degree with 6 months, or a Bachelor's degree. Preferred qualifications include a NC BioWork Certificate and experience in biotechnology or pharmaceutical manufacturing.
Full job description
Career Category
Manufacturing
Job Description
Join Amgen’s Mission of Serving Patients
Since 1980,we’vehelped 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’llhelp 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’llthrive 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 AmgenFleXBatch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. TheFleXBatch 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 - Bulk Drug Substance - Services - DayShift
Live
What you will do
Let’sdo this!Let’schange the world! In this dynamic role, you will be an Associate in the manufacturing organization at Amgen North Carolina (ANC).The essential position, which supports our critical 24/7 manufacturing operations,worksa 12-hour 2-2-3 schedule from 5:45am to 6:15pm.Associates will be completing operations on the floor in our manufacturing servicesareaandwillberesponsible forthe manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.
With general direction, the Associate will support all floor operationsin accordance withcGMPpractices.As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hourshift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.
Responsibilities will include...
Compliance:
Completes workin accordance withestablished 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,monitoringof equipmentinassigned area
Run andmonitorcritical process tasks per assigned procedures
Buffer and Media preparation and transfer
Weigh and dispense of materials to be used in the preparation of Buffers and Medias
Perform in-process sampling,operateanalytical equipment, and complete process documentation (Electronic Batch Records [EBRs])
Complete washroom activities: cleaning equipment, small to large scale, used in production activities
Identifyand escalate issues and concernsregardingdaily 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 weseekare 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 NCBioWorkCertificate 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 todemonstratedesire 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 Plancomprisinghealth 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 relocationassistancewill be provided for these positions
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We helped establish the biotechnology industry, and we remain on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Our investment in research and development has yielded a robust pipeline that builds on our existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.
Amgen is one of 30 companies comprising the Dow Jones Industrial Average®, and part of the Nasdaq-100 Index®. In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes.
For more information, visit Amgen.com and follow us on X, LinkedIn, Instagram, TikTok, YouTube and Threads.
🔗 Community Guidelines: https://wwwext.amgen.com/community-guidelines
🔗Global Privacy Statement Directory: www.amgen.com/dp
Special Advisory: Please be cautious of scam recruitment offers claiming to be from Amgen. Such scams may come from various sources, including fake websites and/or unsolicited emails and seek to obtain personal data or payment from victims by offering jobs that do not exist. Please be advised that Amgen would never ask for payment to progress a job application. When in doubt, please check to see if the position in question is posted on this website before applying. Additionally, please report any suspicious recruiting activity to https://complaint.ic3.gov/ and thank you for your assistance.
Offices: One Amgen Center Drive, Thousand Oaks, CA 91320, US · 1120 Veterans Blvd, South San Francisco, CA 94080, US · 34 Commerce Way, Woburn, MA 01801, US · Avenida Calle 100 7-81, Bogota, Bogota, D.C. 110221, CO · Minervum 7061, Breda, North Brabant 4817 ZK, NL
BiologicsHuman therapeuticsand Development of novel productsHuman ResourcesHealth DiagnosticsHealth CareProfessional ServicesBiotechnologyManufacturingPharmaceutical