Pankaj Naik

At Alcon, Taro and Apotex Pharmaceuticals, leadership in developing analytical test methods and overseeing quality assurance defines my role. My expertise in high-performance liquid chromatography (HPLC) and gas chromatography (GC) has been pivotal in advancing our analytical science and technology initiatives. Spearheading external collaborations, I've ensured the integrity and precision of our analytical processes, reinforcing Alcon's commitment to excellence.

With a strong foundation in R&D from Taro Pharmaceuticals, my work reflects a deep understanding of method Development, Method Validation and data analysis. The team and I have excelled in evaluating out-of-expectation (OOE) trends, contributing to the enhancement of our finished products. This dedicated approach not only supports company innovation but also solidifies our reputation in the pharmaceutical industry.

• +20 years of working experience in R&D Lab & QC Lab of the Pharmaceutical Industries in Canada and USA.
• Experienced in Method Development, Method Validation and Method Transfer of Test Methods of Raw Materials and Finished Products of compendial as well as supplier’s methods using HPLC, UPLC, GC.
• Responsible to manage timely execution and completion of method development and method validation projects in accordance with the department goal, including testing of raw materials and finished products.
• Hands on working experience of GC, HPLC, UPLC, FTIR, UV-vis, KF, and other instruments with a solid understanding of the chromatography principles including its trouble shootings.
• Excellent working experience of Empower-3, Chromeleon, LIMS and other Lab software.
• Strong grasp and knowledge of cGMP, GLP, and GDP; Also familiar with FDA 21 CFR Part 11, HPFBI, ICH and other regulatory requirements.
• Responsible for investigation of internal Out of Specification Results and provided technical support during investigations and assisted in deviation report/root cause analysis/CAPA plan implementation.
• Working experience of various Quality Compliance Systems including but not limited to writing and reviewing SOPs, Protocols, Test Methods, Validation Reports, Technical Reports and Deviation Reports. 
• Mentor, coach and train junior chemists and lab technicians; And Fast learning ability and adaptability to new procedures and processes  sssssssss.
• Strong leadership and project management qualities; excellent detailed oriented, confident, challenger and problem-solving skills, Lead and supervise chemist & lab technician.
• Highly flexible, Organized and manage multiple priorities simultaneously and effectively in a fast-paced environment; Ability to interact professionally with a diverse group of people.
• Excellent working knowledge of computer, MS word, MS excel, and common laboratory software.

Master of Science inOrganic Chemistry        Studied at:   South Gujarat University, Surat, India

Bachelor of Science in Chemistry                      Studied at:   South Gujarat University, Surat, India