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.Specialist Manufacturing, New Product IntroductionsLiveWhat you will doLet’s do this! Let’s change the world! In this vital role you will communicate and interface between the GMP manufacturing teams in the plant and process development scientific groups.
New Product Introduction lead coordinating with Supply Chain, Planning, Facilities and Engineering, Quality, as well as Manufacturing to introduce new Drug Substance products and/or advanced technologies into the plant.
Technical expert who leads or participates in projects, ensuring that production documents are accurate and up to date.
Support Manufacturing in troubleshooting, problem solving and RCAs. Support CAPA development to prevent error recurrence.
Champions Lean Transformation and OE initiatives, facilitates the drive towards continuous improvement in the plant and tracks progress on a plant level.
Collaborate with Regulatory and Quality partners to manage change control records and respond to regulatory questions and/or audit findings.
Generate electronic and paper process documents to ensure plant success. Perform electronic batch record editing and troubleshooting to support production, as required.
WinWhat we expect of youWe are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is an individual with these qualifications.Basic Qualifications:
Doctorate degree OR
Master’s degree in chemistry, biology or engineering & 2 years of biotechnology operations experience OR
Bachelor’s degree in chemistry, biology or engineering and 4 years of biotechnology operations experience OR
Associate’s degree in chemistry, biology or engineering & 8 years of biotechnology operations experience OR
High school diploma / GED & 10 years of biotechnology operations experience
Preferred Qualifications:
Degree in Chemical Engineering, Industrial Engineering, Biology, or Biochemistry
Excellent technical writing skills and experience with electronic documentation systems
Experience with PAS X, Werum software with capability to create and edit in EBR
Experience in GMP operations
Strong technical knowledge of upstream drug substance processing (cell culture, harvest) and a broad understanding of related disciplinary areas in bioprocessing (chromatography, filtration, buffer compounding)
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
Background in lean manufacturing methodologies and operational excellence
Experience in cross functional Project Management
ThriveWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.comAmgen 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.
