About the role

AI summarised

The Senior Associate Quality Control I (Chemistry) role at Amgen Singapore Manufacturing involves performing chemical testing and quality control activities to support biopharmaceutical manufacturing. The position focuses on ensuring product quality and compliance through analytical testing in a regulated environment.

BiotechOnsiteQuality

Key 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.

Requirements

Master’s degree in Chemistry, Biochemistry or related technological field OR Bachelor’s degree in Chemistry, Biochemistry or related technological field and 2 years of directly related experience OR Associate’s 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.