AddressHOW 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.
Manufacturing Specialist
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will have the outstanding opportunity to support the start-up of the Amgen North Carolina (ANC) manufacturing facility. The Manufacturing Specialist will have process ownership and oversight of a manufacturing area that includes activities such as: Raw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, and Autoclave. In this role, responsibilities will include any of the following: Standard Operating Procedure (SOP) creation, review, and approval; design, authoring, implementation, and validation of the electronic batch records; develop, manage, and run change controls associated to new product introductions (NPI); and complete deviation investigations along with corresponding preventive/corrective action records. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to keep the manufacturing area operational.
Responsibilities:
Provide technical support and subject matter expertise for manufacturing area.
Oversee support and ongoing development of all the manufacturing systems including SOP, TRNQ, MES, Trackwise records, among others.
Train staff (supervisors, operators, technical/QA/support) on assigned manufacturing systems.
Support troubleshooting needs during commissioning/qualification, start-up, engineering run, and process performance qualification of the ANC manufacturing facility.
Facilitate process, area, and equipment risk assessments as needed to identify risks, failure modes, and mitigating actions.
Engage in regulatory inspections and in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The ambitious professional we seek is a dynamic problem solver with these qualifications.
Basic Qualifications:
High school diploma/GED and 10 years of biotechnology operations experience OR
Associate’s degree and 8 years of biotechnology operations experience OR
Bachelor’s degree and 4 years of biotechnology operations experience OR
Master’s degree and 2 years of biotechnology operations experience OR
Doctorate degree
Preferred Qualifications:
Educational background in Life Sciences, Chemistry, Biochemistry, Industrial Biotechnology, and/or Engineering.
Strong technical knowledge of drug substance processing (cell culture, harvest, chromatography, filtration, or buffer compounding) and a broad understanding of related disciplinary areas in bioprocessing.
Proficient technical writing and presentation skills so as to communicate complex information effectively with technical and senior management staff.
Experience in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plans.
Collaborate with staff at all levels in the organization, including technical and management staff within manufacturing, process development, engineering, supply chain, and quality.
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.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
