Amgen Sr QC Lab Analyst I in Singapore, Singapore

Role Description:

  • Quality Control Professional with background and experience in commercial production and testing of GMP active pharmaceutical ingredients (API) and Biologics products

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

  • Experiences in lab equipment such as HPLC/UPLC, GC/GC-HS, ICP-MS, LOD, Autotitration, KF, Optical Rotation, Wet chemistry, Spectrophotometry (FT-IR), SoloVPE, pH, conductivity, TOC, PCR, EndoPTS, etc.

  • Management of calibration/PM for lab equipment in the laboratory

  • Experiences in lab system such as Empower, CIMS, LIMS, LMES, Trackwise, etc.

  • Involved in trending of laboratory data (Chemistry/Micro) on periodic basis

  • Involved in compendial review (Chemistry/Micro) and updates for methods

  • Attend teleconference for Amgen network/global meeting (off office hours)

  • Involved in troubleshooting/investigation of issues in manufacturing/laboratory

  • Participate in continuous improvement initiatives and projects.

  • Any other tasks assigned by the supervisor/QC Manager

Education / Licenses

  • Degree in Chemistry or related technological field, or

  • Diploma in Chemistry related technological field.

Relevant Experience

  • > 5 years of relevant work experience in the commercial manufacturing environment within the pharmaceutical or Biologics industry. API chemical production and analytical testing experience preferred.

Competencies / Skills

  • Must have practical knowledge and understanding of GMP pharmaceutical API production, API plant operation and associated technical knowledge on different testing methods.

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

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

  • Experience in laboratory assest management, method validation and transfers

  • Train and mentor peers

  • Interact effectively with cross functional team

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