Team Leader - Analytical R &D (API)
Aurigene Pharmaceutical Services LimitedJob Description
Job Role : Team Leader – Analytical R&D Are you an experienced Analytical R&D professional with a passion for method development and team leadership? We are looking for a Team Leader to join our AR&D team to drive the development, validation, and transfer of robust analytical methods. Role Purpose In this role, you will lead a team of 5 to 10 members to ensure the delivery of high-quality analytical support for process and product development. You will be responsible for completing projects within strict timelines while maintaining the highest regulatory and safety standards. Key Responsibilities - Analytical Method Development: Provide technical leadership in designing experiments and developing various tests to enable seamless process development. - Project Planning & Execution: Manage resource allocation, review/close ELN experiments, and ensure the timely release of analytical reports (Targeting >95% OTIF). - Validation & Tech Transfer: Oversee the preparation and review of validation protocols and reports. Ensure successful method transfers to QC teams with a goal of <2% failure rate. - Cross-Functional Collaboration: Act as the primary analytical point of contact for Customers, Production Engineers, Quality Assurance (QA), and Regulatory Affairs (RA). - Compliance & Safety: Maintain 100% compliance with SOPs and GxP requirements. Lead the team through DQA audits and ensure a zero-incident safety environment. - RFP Support: Provide technical inputs for RFP (Request for Proposal) evaluations to support business development. What We Are Looking For - Education: M.Sc with PhD in Organic/Analytical Chemistry - Experience: 12+ years of experience in Analytical R&D post PhD. Technical Expertise: - Deep expertise in Chromatography. - Strong knowledge of Spectroscopy and solid-state properties. - Proficiency in GxP and regulatory requirements. - Leadership Skills: Proven ability to coach and learn , make data-driven business decisions, and influence stakeholders.
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