Job description
Overview:
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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Job Summary:
This position will report to the Contract & Development Manager Manufacturing. The ideal candidate will have previous experience in aseptic processing in a sterile manufacturing facility with cGMP and Quality System knowledge.
The candidate will have excellent troubleshooting skills using standard industry techniques
Position will be responsible for managing and executing nonconformance, CAPA, SICAR, Change Control and metrics oversight responsibilities for the External Supply organization
Determines situations which require escalation to management
Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting.
Facilitate daily scheduling meetings. Ensure current schedule is maintained, accurate, and up to date.
Be responsible for compiling, maintaining and reviewing all necessary reports
Assist, plan and implement continuous improvement ideas / opportunities
Contribute and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
Complete any other duties as requested by Site Manufacturing Management.
Basic Requirements
Be a results-oriented person with excellent organizational, communicational and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation
Demonstrated ability to deliver to team, site and personal objectives
Able to successfully manage workload to timelines
Familiarity with basic project management tools
Demonstrated understanding and use of RFT techniques and lean manufacturing concepts
Strong ability to lead, challenge and positively influence in an interactive team environment
Strong computer skills - knowledge Quality tracking system (QMTS).
Basic Qualifications:
Master’s degree OR
Bachelor’s degree & 2 years of directly related experience OR
Associate’s degree & 6 years of directly related experience OR
High school diploma / GED & 8 years of directly related experience
Preferred Qualifications:
2+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes
Join Us
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
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