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Senior Associate Quality Control

2 weeks ago

Singapore Amgen Full time

**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
- 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

**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

**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.

**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.