Specialist QC I

R-203502 Specialist QC I

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 Specialist QC I in Singapore.

Live

What you will do

• Ensure laboratory systems and operations meet GMP compliance and Amgen Quality Management System requirements.

• Work in a cross functional team with Process Development, Manufacturing, Supply Chain, Engineering and Facilities to ensure product quality and market supply

• Provides technical support to ensure the manufactured products meet the applicable regulatory standards and guideline with respect to Quality Control.

• Coordinate work, tasks and project assigned to the teams.

• Responsible for planning, scheduling and performing laboratory testing and approval of test results on in-coming raw materials, utility water, In-process control, drug substance intermediate, final release, stability and plant cleaning samples in a GMP pharmaceutical environment.

• Conduct or lead laboratory investigations and assist in timely closure of investigations, CAPAs and deviations

• Support laboratory operations including but not limited to equipment qualification, calibration, cleaning and maintenance, reagent/buffer preparation.

• Lead/ participate in new product introduction and support method verification/ validation/ transfer.

• Facilitate training of new/ junior laboratory staff and sure all staff are appropriately trainined and qualified to execute the duties assigned to them with respect to the job.

• Author of SOP/protocols/reports.

• Support periodic review of laboratory procedures, technical study protocols, reports and assessments (e.g trend reports, risk assessments)

• Subject matter expert for areas including but not limited to sample plans, lab electronic systems (such as LIMS, LIMS templating), trending (such as method trending, assay control trending, EM & utilities), laboratory metrics, equipment system owners and method owners.

• Prepare, support audit and represent Quality Control function during regulatory inspections.

• Lead continuous improvement initiatives and projects.

• Any other tasks assigned by the supervisor/QC 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

• Doctorate degree in Chemistry, Biochemistry, Life Science or related technological field OR

• Master’s degree in Chemistry, Biochemistry, Life Science or related technological field and 2 years of directly related experience OR

• Bachelor’s degree in Chemistry, Biochemistry, Life Science or related technological field and 4 years of directly related experience

• High school diploma / GED in Chemistry, Biochemistry or related technological field and 8 years of directly related experience

• 6-8 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.

• Demonstrated knowledge and application of sound scientific principles, theories, techniques and skills.

• Demonstrated experience in GMP laboratory operation including development and management of systems for equipment qualification, method validation/transfer, sample management, data management, trending and OOS investigations

• Strong technical knowledge in and experience with the following QC Chemistry/ Biochemistry 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 Electrophoresis, ICP-MS, LOD, Autotitration, KF, Optical Rotation, FT-IR, Conductivity, TOC, pH, wet chemistry

• Meticulous in assay review and approvals.

• Ability to forecast workload, assess incoming sampling and testing volume, plan and coordinate assignment of shift work, and allocate/ re-allocate resources accordingly

• Ability to work well with teammates of varying working styles, and gel the team together

• 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

• Ability to coach, mentor and/or cross train staff within core technical areas

• Ability to assess individual’s strength and weaknesses

• 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

• Leadership skills and keen on developing into management roles in the future.

• Ability to make decisions in relation to laboratory operations in the absence of the manager.

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.