Manager Analytical Development

Company Description Leben Life Sciences Pvt. Ltd. is an Indian pharmaceutical development and manufacturing company that supports partners from product opportunity through to commercial supply. With 46 years of industry experience and operating independently since 2016, the company integrates product development, regulatory capabilities, quality systems, manufacturing, and supply execution in one organization. Its EU-GMP certified platform covers tablets, capsules, and topical formulations, supported by in-house formulation and analytical development, pilot-scale capabilities, and regulatory services. Leben's capabilities span formulation and analytical development, dossier and registration support, technology transfer, scale-up, commercial manufacturing, packaging, quality systems, and supply planning. The company works with global importers, distributors, and partners, with more than 34 product dossiers registered and around 170 product registrations underway across 20+ overseas markets, supported by dedicated Regulatory Affairs and R&D teams.
Role Description The Manager Analytical Development is a full-time, on-site role based in Akola, responsible for leading analytical development activities for pharmaceutical products. Day-to-day responsibilities include designing and developing analytical methods, overseeing validation and transfer of methods to quality control laboratories, and ensuring compliance with regulatory and internal quality standards. The role involves managing laboratory operations, supervising analytical development teams, reviewing and approving analytical protocols and reports, and troubleshooting complex analytical issues. The manager will collaborate closely with R&D, quality assurance, regulatory affairs, and manufacturing teams to support formulation development, scale-up, technology transfer, and commercial production. Additional responsibilities include maintaining documentation, driving continuous improvement in laboratory practices, and supporting audits and inspections.
Qualifications

• Candidates should possess strong expertise in Analytical Methods Development and Method Development for solid oral and topical dosage forms.
• Candidates should possess solid Quality Control experience, including method validation, specification setting, and data review.
• Candidates should possess advanced Laboratory Skills, including use of chromatographic and spectroscopic instruments (e.g., HPLC, GC, UV, dissolution).
• Candidates should possess experience in Research and Development (R&D), supporting formulation development, scale-up, and technology transfer.
• Postgraduate or graduate degree in Pharmaceutical Sciences, Chemistry, or a related discipline.
• Proven experience (typically 8+ years) in analytical development within a regulated pharmaceutical environment; prior leadership or supervisory experience is preferred.
• Strong understanding of regulatory guidelines (e.g., ICH, WHO, EU-GMP) and documentation requirements for dossiers and product registration.
• Effective people management, project management, and cross-functional collaboration skills, with the ability to work to timelines and manage multiple projects.
• Attention to detail, strong problem-solving abilities, and proficiency in relevant laboratory software and