Bioequivalence Scientist

Job Responsibilities: 1) Accountable for effectiveness of Bioequivalence/Bioavailability and Toxicology studies according to various pharma guidelines from US FDA, EU, UK MHRA etc. by managing the full cycle of the BE studies from method validation, review sample analysis protocols, clinical protocols and bioequivalence study reports. 2) To manage the entire bioequivalence and bioavailability process including new analytical methods development, oversee entire method validation processes, implement bioanalytical parameters, to review method proposals, method validation protocols, method validation working instructions and method validation reports. This includes development and validation of bio-analytical methods in biological matrix using LC-MS/MS Systems. 3) To research and identify reference listed drugs (RLD), reference standards (RS), and the basis of submission to any regulatory authorities for considerations in developing BE methods. 4) To be responsible from design, review and evaluation of BE studies from in vitro BE study including method development report (e.g., IVRT, IVPT etc.), method validation report to ensure accuracy and precision of the methods and its method robustness, Pivotal BE study report and In vivo BE studies including study protocols and study reports. 5) To be responsible for development, qualification and execution of novel LCMS, ELISA methods to support bioequivalence, pharmacokinetics (PK) studies. 6) To lead the activities for bioanalytical method development, validation and sample analysis. 7) To design and implement study feasibility depending on dosage, instrument sensitivity and complexity of bioanalysis. 8) To review method validation, sample analysis protocols, clinical protocols, bioequivalence study reports, and relevant SOPs. 9) To propose, manage and review project management of each bioequivalence study including costing. 10) Ensure the relevant SOPs and compliances according to the latest guidelines of various authorities from NPRA, US FDA, EU, UK MHRA and others. 11) To train and develop local employees with the aim to grow the BE Centre as a recognized clinical research organization (CRO) to conduct bioequivalence and bioavailability studies for pharmaceutical companies globally. Job Requirements: - Masters/Degree in Pharmacy, Sciences or related discipline, preferably in Bio-Analytical Chemistry. - Successful track record in producing clinical and bioequivalence studies. - Minimum 10 years’ experience bioequivalence in clinical research - Experienced in bioequivalence of pharmaceutical for regulated market like USFDA, EU, MHRA-UK, TGA-Australia and others. - Proficient in various sample preparation techniques use in bioanalysis of drugs, metabolites, proteins, hormones and other endogenous compounds using LCMS, ELISA. - Experienced in handling multiple aspects in bioequivalence studies such as bioanalysis, report review, SOP writing and setting quality standards.
Attest Research Sdn. Bhd. is doing research and development of pharmaceutical products including formulation development; technology transfer and stability study of drug products. Besides this, Attest Research Sdn Bhd also develops new molecules and undertakes product improvement through drug delivery systems and method developments.
Bachelor's or Equivalent