Manager

​​In-depth understanding on testing of any pharmaceutical drug samples including APIs, intermediates, excipients, finished products etc., with good commercial awareness and customer focus

Main Accountabilities

• ​Overall in-charge for pharmaceutical testing lab with complete understanding all the technical requirements as per cGMP
• Hands on experience in analytical method development, verification and validations for Genotoxic Impurities, Extractable and Leachable and Elemental Impurities using LCMS/MS, GCMS/MS and ICP-MS

Qualifications, Experience and Technical Skills

• ​​PhD or MSc in Chemistry or Pharmaceutical Sciences
• Minimum 10-15 years of experience from the pharmaceutical industry. out of which five years shall be in a managerial Position
• Overall in-charge for pharmaceutical testing lab with complete understanding all the technical requirements as per cGMP
• Managing day-to-day operations of the pharmaceutical testing laboratory.
• Excellent team building capability backed by interpersonal communication skills
• Significant experience in analytical Method Development, Method validations, Calibrations, Work planning, customer dealing, and performing for R&D, plant requirements and regulatory bodies
• Organizational, problem solving, risk analysis and negotiation
• Good strategic planning, managerial capabilities with effective time management in meeting specific timelines (TAT) for customer samples
• Hands on experience in analytical method development, verification and validations for Genotoxic Impurities, Extractable and Leachable and Elemental Impurities using LCMS/MS, GCMS/MS and ICP-MS
• Effectively communicate and collaborate with Business Development/sales, Management.
• Handling with the clients, understating their requirements inclusive of new projects and strategies related to sample testing
• Coordinating with sales team for new projects & ongoing projects
• Ensure to set and meet sales targets/revenues and optimize the cost incurred
• Responsible for preparation / approval of method development, verification and validation protocols and reports
• Troubleshooting knowledge of all advanced instruments LC-MS/MS, GC-MS, AAS, ICP-OES, ICP-MS etc.
• Updated cGMP knowledge in effectively implementing to the requirements of USFDA, MHRA, EU-GMPs
• Handling of Extractable and Leachables projects in association with the customer for understanding the actual requirements
• Awareness on all method development and validation guidelines as per ICH guidelines and other regulatory guidelines
• Team player with good oral and written communication skills
• Capable to work and support the lab in timely deliveries of results