Job Description

CLIENT: Leading manufacturer of active pharmaceutical ingredients (APIs) and an end-to-end solution provider for the pharmaceutical industry\'s chemistry needs. This organisation has a presence in over 80 countries with more than 75% of revenues accounted for by exports.US and Europe are key markets, accounting for 70% of total revenues. KEY DELIVERABLES: Spearhead analytical development operations comprising multiple CRAMS projects for leading, directing and motivating cross-functional project teams to accomplish project goals to agreed timelines. Identify and negotiate schedules, milestones, and resource requirements to meet project outcomes. Develop project plans specifying staffing, scheduling, identification of risks, contingency plans, and allocation of available resources. Co-ordinate all AR&D Laboratory activities, Analytical method development and validation and deficiency Query etc. Review Technical documents including validation protocol, Reports, analysis test procedure, technical reports, change control, Standard operating procedure and write-up for deficiency queries. Identify opportunities for quality enhancement and operational efficiencies and develop efficient methodologies to track the progress. Develop SOPs, procedure, systems and training activities to develop appropriate level of scientific expertise within AR&D, to ensure successful execution of the project work. INCUMBENT PROFILE: 20 years of experience with MSc/part time Ph.D. or 10-15 years of experience with regular Ph.D. Structural characterization expertise using NMR, LCMS, GCMS etc and solid-state characterization using XRPD, DSC, TGA etc.. Method developments and validations expertise on Nitrosamines/GTIs is highly required. Adequate real time experience in Analytical method developments and Validations using HPLC, GC, LCMS, GCMS Real time exposure on analytical method developments and purifications of peptide molecules. Good exposure on analytical support to API commercialization by handling regulatory queries. Exposure in handling regulatory audits is required. ANNUAL REMUNERATION: 30-35LPA Queries: Anoop Sinha- CEO,PROFILE HR CONSULTANTS PVT LTD [HIDDEN TEXT] Cell- 9773520069

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