Job Information
Amgen Senior Associate Quality Control in Singapore, Singapore
Senior Associate Quality Control (Chemistry)
Singapore
HOW MIGHT YOU DEFY IMAGINATION?
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 a Senior Associate Quality Control (Chemistry) in Singapore.
Senior Associate Quality Control (Chemistry)
Live
What you will do
Main Responsibilities:
Plan, schedule, perform analytical testing and approval of test results on raw materials, water, in-process control, drug substance and stability samples in GMP pharmaceutical environment.
Troubleshooting issues related to analytical testing, techniques and equipment
Conduct laboratory investigations and assist in timely closure of investigations, CAPAs and deviations
Support method verification and method validation/transfer for new product introduction (when required)
Train new/ junior laboratory staff and ensure all staff are appropriately trained and qualified to execute the duties assigned to them with respect to the job
Support laboratory operations including but not limited to equipment qualification, calibration and maintenance, reagent/buffer preparation, chemicals/consumables inventory, laboratory housekeeping and document archival duties
Perform periodic review of laboratory procedures and risk assessment.
Author of SOPs/protocols/reports.
Support regulatory inspections.
Participate in continuous improvement initiatives and projects.
Shift work may be required
Any other tasks assigned by the Quality Control Manager
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
Master’s degree in Chemistry, Biochemistry or related technological field OR
Bachelor’s degree in Chemistry, Biochemistry or related technological field and 2 years of directly related experience OR
Associate’s degree in Chemistry, Biochemistry or related technological field and/or 6 years of directly related experience OR
High school diploma in Chemistry, Biochemistry or related technological field / GED and 8 years of directly related experience
Preferred 4 years of relevant professional work experience within the pharmaceutical or biopharmaceutical industry and laboratory testing experience preferred.
Strong knowledge and understanding of GMP pharmaceutical production, pharmaceutical plant operation and associated testing methods.
Strong technical knowledge in and experience with the following QC Chemistry/ Biochemistry/ Raw material testing methods and equipment is required:
Immunosorbent Assay/Cell based Bioassay: Potency, Host Cell Proteins, ELISA
Chromatography: UPLC, HPLC, LC-MS, GC-HS
General Chemistry: Capillary Electrophosis, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry
Ability to preempt issues and disruptions to lab operations and develop mitigation actions
Problem solving skills with the ability to apply logic, utilize technical knowledge and assess data to troubleshoot issues and derive appropriate GMP decisions and solutions
Experience in laboratory asset management, method qualification and transfers
Ability to coach, mentor and/or cross train staff within core technical areas
Good communication skills (technical writing and verbal communication/presentation)
Interact effectively with cross functional team and ability to work well in teams
Ability to manage multiple simultaneous activities in a rapidly changing environment
Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so, you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
careers.amgen.com
Equal Opportunity Statement
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 a 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 an accommodation.