ROLE & RESPONSABILITIES
The analytical scientist position will manage the Analytical development program on pipeline products for global registration of injectable and non-injectable products. The incumbent will demonstrate competency, flexibility, and versatility in keeping abreast with evolving regulatory guidelines and ensure compliance with requirements, especially those of US FDA and EMA for filing generics and a hybrid / 505 b2 products. The incumbent will collaborate effectively with internal teams and external service providers to ensure that commitments, timelines, and deliverables are achieved.
- Prepare analytical study documents, including protocols, reports, work instructions, relevant SOPs to ensure that testing of pharmaceuticals, and any associated equipment qualifications and calibrations, meet current regulatory standards.
- Perform the literature research and ensure the analytical method follow the compendial requirements (e.g. USP, Ph.Eur.), wherever applicable. In absence of monograph requirements, either develop and validate testing methodologies and procedures using chromatographic (HPLC, GC, LCMS) and spectroscopic techniques (UV, FTIR), following ICH, USP, US FDA, EMA requirements at on-site/off-site development and manufacturing site.
- Review of the methodologies given in the Drug Master File (DMF) or ASMF, Pharmacopeias, Product-specific guidance documents, and prepare the strategy for the drug substance qualification and excipient qualification testing.
- Prepare the analytical testing protocols for characterization of reference listed drug products (RLD), Reference Products, identify the quality attributes, critical quality attributes (CQA) as per Quality by Design (QbD) concepts, such as include assay, identification, organic and inorganic impurities, product performance studies, elemental impurities, leachables, pH, viscosity, osmolarity, particle size, polymorphism, residual solvents, optical rotation, etc. for the Injectable and Non-Injectable drug products developments.
- Ensure the testing reference standards, laboratory consumables, chromatographic columns, test request forms, and testing licenses are arranged before the initiation of the off-site testing at the Contract Development laboratory and Manufacturing site, and ensure the sufficient stock is maintained.
- Lead the review of laboratory notebooks, chromatographic data, spectroscopic data, and histograms during testing. Identify the impurity trends, out of specifications (OOS), System suitability trends, carry out the investigation on-site/off-site and optimize the methodologies if necessary.
- Ensure and review the stability studies, support the troubleshooting of the analytical methods, harmonize the minimum testing requirements across the testing sites.
- Support the activity for the setting of the specifications for release and shelf life in coordination with Formulation R&D and Regulatory affairs teams.
- Support the activities related to risk assessments and testing for Elemental impurities, Nitrosamines, Extractables and leachables, diluent compatibility study, In-use stability studies, and Accelerated Predictive stability studies.
- Identify training needs and mentor junior staff, and actively participate in seminars/webinars for self-and team development.
- Minimum Qualification: Master degree in Analytical Chemistry, Organic chemistry, pharmaceutical analysis, or equivalent.
- Minimum Experience: An experienced candidate of 5 years in the analysis.
- Languages: Very good English (written and oral). Other languages are an asset.
- Hands-on experience on analytical instruments (HPLC, GC, IR, UV Spectroscopy, dissolution) and demonstrate a strong understanding of the Chemistry principles and their application.
- Communication skills (fluent English speaker)
- Essential professional attributes include detailed-oriented analytical thinking, a team-player attitude, respect and understanding for cultural differences in different countries, and efficient utilization of time and resources.
- Proficient in Microsoft Office Suite, especially Teams, Excel, Word, PowerPoint and Outlook