Amgen Specialist QC (Chemistry) in Singapore, Singapore

Role Description:

  • 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.

  • Responsible for planning, scheduling and performing laboratory testing and reviewing of test results on in-coming raw materials, utility water, In-process control, drug substance samples in 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.

  • Participates in method verification and method validation/transfer (when required)

  • 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.

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

  • Lead continuous improvement initiatives and projects.

  • Any other tasks assigned by the supervisor/QC Manager.

Education / Licenses

  • Doctorate degree & 2 years of directly related experience OR

  • Master's degree & 4 years of directly related experience OR

  • Bachelor's degree & 8 years of directly related experience

Relevant Experience

  • 6-8 years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry, API production and analytical testing experience preferred.

Competencies / Skills

  • Demonstrated knowledge and understanding of cGMP, GLP and associated regulatory expectations related to pharmaceutical and associated testing methods.

  • Demonstrated experience and competency in Quality Control testing and GMP laboratory operations for pharmacopeia testing methods and equipment (HPLC, wet chemistry, Gas Chromatography, Residual Solvents, Liquid Chromatography-Mass Spec, Heavy Metals, Bioburden, Endotoxin)

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

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

  • Train and mentor junior laboratory staff

  • Experience in laboratory assest management, method qualification and transfers

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

  • Identify, understand and organize daily laboratory work in support of manufacturing operations

  • Interact effectively with cross functional team

  • Problem solving skills and troubleshooting skills with the ability to apply logic and assess data to reach decisions and solutions related to compliance and product quality

Additonal Requirements

  • Work on shift schedules may be required