Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring an Associate Manufacturing in Amgen Singapore Manufacturing.
Live
What you will do
Responsibilities:
- Involve in hands-on execution of the plant operations and assist in troubleshooting
- Monitor and analyze processing parameters for atypical trends and improvement opportunities
- Perform solution, equipment preparation, cell culture and purification operations as required
- Perform raw material and singe use parts staging and dispensing with additional logistical support responsibility
- Stage components for autoclaving and washing
- Perform filter integrity testing of sterilizing filters
- Support in-process testing of production samples, prior experience with analytical instrument
- Actively support continuous improvement initiatives
- Support Safety audits
- Adhere to any applicable EHS requirements
- Ability to adhere to regulatory requirements, written procedures and safety guidelines
- Ability to evaluate documentation/data according to company and regulatory guidelines
- Ability to interact with inspectors (internal and external)
- Ability to interpret and apply Good Manufacturing Practice (GMP) knowledge
- Basic statistical mathematical skills
- Ability to organize work and handle multiple priorities and meet deadlines
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Regulatory knowledge
- Understanding of analytical methods
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
Win
What we expect of you
Qualifications
- Bachelor’s Degree and 2 years of directly related experience OR
- Associate’s Degree and 4 years of directly related experience
- Diploma and 6 years of directly related experience
- Knowledge of plant and unit operations (autoclave, parts washers, process equipment), good problem-solving skills
- Demonstrate commitment to cGMP, EHS compliance aspects of clean-room plant operation, prior experience and demonstration of cGMP knowledge is a plus
- Excellent self-motivated team player with hands-on attitude and good communication skills
- Experience with Emerson DeltaV, LIMS, TrackWise
- Ability and willingness to work any shift in support of operations that may include 24/7
- Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using LMS.
- Ability to understand, apply and evaluate basic chemistry, biology and physical principles
- Mechanical ability/expertise
