Analytical Scientist

This is an 11-month contract. Purpose The Biologics Analytical Research & Development department is seeking applicants for a Scientist position which is a laboratory-based scientific role tasked with analytical testing of drug substance for release, stability and characterization of biologic products under GMP/GDP and analytical method validations/transfers. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Responsibilities Execution of analytical method validations and transfers (among different sites, and between the company and CROs) and write technical protocols and report Execution of analytical testing of drug substance release, stability and characterization for biologics under GMP/GDP Support equipment maintenance, calibration and qualification work Preparation of analytical methods, SOPs and other documents as required Other analytical activities in consultation with the Supervisor Works in accordance with applicable internal company regulations: safety, health and environmental protection. Train new analysts Requirements M.S in analytical chemistry/biochemistry or related field or B. S with a minimum of 3 years of experience in the Pharmaceutical Industry.? Experience with analytical testing with Ultrahigh Pressure Liquid Chromatography (UPLC)/High Performance Liquid Chromatography (HPLC), Capillary Electrophoresis, or other large molecule characterization technique Strong oral and written communication skills Ability to work in a team environment with cross-functional interactions is essential GMP working experience Perform supporting activities for general lab operations, training, new product introduction, method verifications and method transfers. Execution and review of analytical method validations and transfers (among different sites, and between the company and CROs) Execution and review of analytical testing of drug substance release, stability, method qualification, incoming goods, ID testing, and characterisation for biologics under GMP/GDP. Cross-train Scientists within the department for new and existing technologies. Ability to organise and establish testing schedules and adhere to deadlines. Support equipment maintenance, calibration and qualification work Perform periodic review of instrument systems Generate instrument data in support of SDLC Validation. Initiate, review, and support deviations, CAPAs, and, risk assessments, and change records as required. Preparation of analytical methods, SOPs and other documents as required Understanding of current manufacturing processes Author technical protocols and reports as required Analyse and optimise current lab/business processes in the laboratories and support implementation activities of the technologies and methodologies. Skills: Analytical Testing Drug Substance SOPs HPLC UPLC