{"id":3477391,"url":"https://alion.io/job/biocon-solutions-pharmaceutical-chemist","title":"Pharmaceutical Chemist","company":{"id":3802323,"name":"Biocon 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Empower","optional":false}],"status":"live","first_seen_at":"2026-10-29T18:28:01Z","employer_posted_date":null,"last_verified_at":"2026-10-29T18:28:01Z","board_verified":false,"closed_at":null,"days_open":3,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":3},"description":"Job Description of Pharmaceutical Chemist\nKey Roles & Responsibilities\n1.Analytical Testing & Method Development\nPerform complex chemical and physical analyses of active pharmaceutical ingredients (APIs), excipients, in-process materials, and finished drug products using advanced analytical instrumentation (including HPLC, UHPLC, GC, UV-Vis, FTIR, Dissolution, and Karl Fischer titration).\nDevelop, optimize, and validate new analytical methods in strict accordance with ICH Q2 (R1/R2) guidelines and pharmacopeial standards (USP, EP, BP, JP).\nExecute method transfers between R&D, contract manufacturing organizations (CMOs), and Quality Control (QC) laboratories.\n2.Formulation Support & Stability Studies\nCollaborate with the formulation and process development teams to evaluate the chemical compatibility of excipients and APIs during pre-formulation and scale-up phases.\nDesign, manage, and execute stability testing programs (accelerated, intermediate, and long-term) in compliance with ICH Q1A–Q1E guidelines to establish product shelf-life and storage conditions.\nAnalyze stability data trends and author comprehensive technical stability reports for regulatory submissions.\n3.Quality Assurance, cGMP & Regulatory Compliance\nEnsure all laboratory testing, documentation, and data recording strictly adhere to current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and ALCOA+ data integrity principles.\nLead technical investigations into Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviation events; perform root-cause analysis (RCA) and implement effective Corrective and Preventive Actions (CAPA).\nPrepare and review Standard Operating Procedures (SOPs), analytical test protocols, Specifications, and Certificates of Analysis (CoA).\nSupport internal quality audits and external regulatory inspections by the Singapore Health Sciences Authority (HSA), US FDA, EMA, and PIC/S authorities.\n4.Laboratory Management & Mentorship\nOver see the routine calibration, qualification (IQ/OQ/PQ), and preventive maintenance of analytical laboratory instruments, troubleshooting hardware and software issues to minimize downtime.\nManage laboratory inventory, reference standards, reagents, and chemical waste disposal in compliance with Singapore National Environment Agency (NEA) and Workplace Safety and Health (WSH) regulations.\nProvide technical guidance, training, and mentorship to junior chemists and laboratory technicians to maintain high analytical standards and operational efficiency.\nJob Requirements & Qualifications\nEducation: Bachelor’s Degree, or master’s degree, in Chemistry, Pharmaceutical Sciences, Analytical Chemistry, Medicinal Chemistry, or a closely related scientific discipline from a recognized institution.\nExperience: Minimum of 6 years of relevant hands-on experience in a pharmaceutical, biopharmaceutical, or GMP-regulated analytical/formulation laboratory environment.\nTechnical Expertise:\nDemonstrated proficiency in operating and troubleshooting chromatographic and spectroscopic instruments (e.g., HPLC, GC, FTIR, UV-Vis) and Chromatography Data Systems (e.g., Waters Empower, Agilent Open Lab).\nStrong working knowledge of analytical method development, validation, and pharmacopeial compendia (USP/EP/BP).\nProven track record in managing OOS/OOT investigations, root-cause analysis, and CAPA implementation within a Quality Management System (QMS).\n\nRegulatory Knowledge: Thorough understanding of cGMP, GLP, ICH guidelines, PIC/S standards, and local HSA regulatory requirements.\nCore Competencies:\nStrong analytical and critical-thinking skills with meticulous attention to detail and data integrity.\nAbility to author clear, concise technical protocols, validation reports, and regulatory documentation.\nEffective interpersonal and communication skills to collaborate across cross-functional teams (Quality Assurance, Regulatory Affairs, Production, and R&D).\n\nSkills\nFDA standards, Analytical Chemistry, USP, Technology Expertise, Local Regulations, scientific discipline, Chromatography Equipment Operation and Control, Analytical Testing, Bp, CMOS, Methods Engineering, Analytical Methods Development, Operational Technology Security Audit Management, Education, Analytical Method Validation, Regulatory 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