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 workplace.
- 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.
📌 Team Leader - Analytical R &D (API) (Hyderabad)
🏢 Aurigene Pharmaceutical Services
📍 Hyderabad
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