Chemistry Jobs at Harmoni Analyticals
Company name: Harmoni Analyticals
Job Title: Sr. Scientist (Extractables & Leachables)
Location: Hyderabad
Employment Type: Full-time
Qualification: M.Sc or Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related discipline
Experience: 5–8 Years Experience
Gender: No such preference
Salary: ₹13–17 L ctc, 5% hike on the level of seniority
Job Summary:
As a Senior Scientist specializing in Extractables & Leachables (E&L), you will be the technical subject matter expert responsible for designing, executing, and overseeing end-to-end E&L studies under Harmoni’s GLP-compliant analytical chemistry framework. Working in Harmoni’s Hyderabad (or allied R&D) facility, you will collaborate across teams (analytical chemistry, quality assurance, regulatory affairs, and clients), guiding both study strategy and execution. Your role will be pivotal in ensuring scientific integrity, regulatory readiness, and client satisfaction in all E&L deliverables.
Key Responsibilities:
• Lead and design E&L risk assessments, study plans, and execution protocols for container-closure systems, packaging, and other materials that may interact with drug or chemical products.
• Develop, validate, or adapt analytical methods using instrumentation such as LC-MS/MS, GC-MS/MS, ICP-MS, HS-GC/MS, etc., for both volatile and non-volatile extractables, and leachables.
• Manage sample preparation workflows (solvent extraction, headspace, reflux, etc.), instrument calibration/maintenance, and instrument qualification (IQ/OQ/PQ) where needed.
• Analyze, interpret, consolidate data; perform compound identification (including unknowns), quantification, and ensure that findings align with regulatory thresholds or safety limits.
• Author, review and maintain analytical documentation—protocols, validation reports, Certificates of Analysis, study reports, SOPs, regulatory submissions.
• Mentor junior scientists, provide technical oversight, and coordinate with QA/RA teams and clients to ensure all E&L activities meet regulatory, GLP, and quality standards.
• Serve as interface with clients to understand requirements, present findings, respond to queries, and support submissions (IND/BLA or other regulatory dossiers as appropriate).
• Stay current with evolving regulatory guidelines (e.g. PQRI, USP <1663>/<1664> etc.), best practices in E&L science, and lab safety / compliance norms.
• Complete audits and ensure compliance with ethical and quality standards.
Qualifications & Skill Set
• Education: Minimum Master’s degree in Analytical Chemistry, Pharmaceutical Chemistry, Chemistry, or related discipline; PhD preferred for highly senior / leadership roles.
• Experience: Typically 5-10+ years of hands-on experience in E&L studies in CRO, pharma, or medical device industries. Experience with both extractables (material testing) and leachables (actual migration with drug/contact) highly valued.
• Technical Skills: Proficiency with chromatographic & mass spec techniques (LC-MS/MS, GC-MS/MS, ICP-MS etc.), sample prep (liquid/solid extractions, headspace, etc.), data analysis including unknown compound deconvolution.
• Quality & Compliance: Strong understanding of GLP, GMP, regulatory expectations, documentation standards, data integrity.
• Soft Skills: Scientific writing, communication with cross-functional teams/clients, project management, leadership / mentorship ability, problem solving, attention to detail.
Interview Process:
• Mode: Direct Interview
• Rounds: 3 Rounds
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