Senior Associate Quality Control I

Senior Associate Quality Control

Amgen Singapore Manufacturing

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 in Singapore.

Live

What you will do

Responsibilities

• Responsibilities may include but are not limited to:

• Execute testing and/or review, such as routine environmental, water, raw material and product testing and approvals (e.g. bioburden, endotoxin, qPCR, microbial ID etc.); media, reagent and culture qualification and approvals (e.g. growth promotion, DNA positive controls, ATCC/ Bioballs, etc.)

• Sample management which may include logging of samples, movement and storage of samples, reconciliation of sample receipt, aliquoting of samples, management of stability samples, shipment of samples to Amgen network sites and/or contract labs, and lot authorization and disposition

• Laboratory inventory management to ensure operational readiness

• Equipment procurement, installation commissioning and qualification, calibration and maintenance

• Troubleshooting and resolving issues related to testing and/or equipment

• Involvement in New Product Introductions (NPI), method validation/verification and sample type validation

• Draft technical study protocols, reports and assessments (e.g. trend reports, risk assessments, etc)

• Perform and support deviation investigations and CAPAs implementations

• Support change controls and/or applicability assessments

• Driving Operational Excellence and Continuous Improvement projects

• Support and front regulatory inspections topics

Win

What we expect of you

Basic Qualifications

• Master’s degree in Microbiology, Biological Sciences, Life Sciences or related technological field OR

• Bachelor’s degree in Microbiology, Biological Sciences, Life Sciences or related technological field and 2 years of directly related experience OR

• Associate’s degree in Microbiology, Biological Sciences, Life Sciences or related technological field and/or 6 years of directly related experience OR

• High school diploma in Microbiology, Biological Sciences, Life Sciences or related technological field / GED and 8 years of directly related experience

• 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 the following QC microbial testing methods and equipment is required:

  • Bioburden Test & Microbial Limits Test (membrane filtration, spread plate, pour plate, aerobic and anaerobic bioburden)

  • Endotoxin (kinetic LAL techniques, chromogenic, experience using Endosafe PTS and plate reader equipment)

  • Microbial identification (morphology selection, streaking for isolation, knowledge on microorganisms, gram stain, experience using Bruker MALDI-TOF equipment)

  • Growth promotion (solid culture inoculation, liquid culture inoculation, microbial culture qualification, In-house microbial library i.e. isolate selection, preparation, freezing, maintenance)

  • Environmental monitoring (air, surface, personnel)

  • Utilities monitoring (water, compressed gas)

• Knowledge in the following QC Microbial Testing techniques is preferred but not mandatory

  • Biological Indicator testing

  • Quantitative Polymerase Chain Reaction (qPCR)

• Meticulous in assay review and approvals.

• Ability to work well with teammates of varying working styles

• 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

• Good communication skills (technical writing and verbal communication/presentation)

• Interact effectively with variety of communication and working styles 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.

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.