Senior Associate Quality Control I (Chemistry)

Career Category

Job Description

Senior Associate Quality Control I (Chemistry)

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION

Amgen is one of the worlds 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 I (Chemistry) in Singapore.

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

• Masters degree in Chemistry Biochemistry or related technological field OR
• Bachelors degree in Chemistry Biochemistry or related technological field and 2 years of directly related experience OR
• Associates degree in Chemistry Biochemistry or related technological field and/or 4 years of directly related experience OR
• High school diploma in Chemistry Biochemistry or related technological field / GED and 6 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

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

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.

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.

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.