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Senior Associate Quality Control
1 week ago
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, bringing state-of-the-art medicines from laboratory to the patient. We are hiring a
Senior Associate Quality Control (Chemistry)
in Singapore.
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 a GMP pharmaceutical environment.
Troubleshoot 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 their duties.
Support laboratory operations including 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 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 essential functions of this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
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.
Strong knowledge and understanding of GMP pharmaceutical production and associated testing methods.
Strong technical knowledge in QC Chemistry/Biochemistry/Raw material testing methods and equipment:
Immunosorbent Assay/Cell based Bioassay: Potency, Host Cell Proteins, ELISA
Chromatography: UPLC, HPLC, LC-MS, GC-HS
General Chemistry: Capillary Electrophoresis, 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.
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).
Ability to manage multiple simultaneous activities in a rapidly changing environment.
What you can expect of us
Vast opportunities to learn and move up and across our global organization.
Diverse and inclusive community where teammates are empowered to bring ideas to the table.
Generous Total Rewards Plan comprising health, finance, 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 reasonable accommodations to participate in the job application or interview process. Please contact us to request an accommodation.
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