Assistant Manager - Analytical Research & Development

Job Description

Job Summary

• Responsible for developing, validating and applying analytical methods in compliance with current compendial pharmacopoeias, ICH, SOP and GMP requirements. 
• Evaluation of R&D samples in support of selection of API suppliers, specification development and NPD process.
• Preparation of TAP (Transfer of Analytical Procedures) protocol and Report for various sites. Procuring respective samples and Impurities accordingly. Planning and executing the assigned TAP projects to various sites.
• Providing scientific support to Product Evaluation, Formulation and Process Development. 
• Responsible to ensure and monitor most complex tasks and high priority special projects. 
• This position requires effective problem solving and resolution in designated day-to-day operations. 
• This role requires to collaborate & participate meetings with multidisciplinary teams to resolve complex product development issues. 
• Lead projects as assigned, working both independently and in collaboration with the team to deliver assignments on time. 
• Review of laboratory data, instrument logbook and reports wherever applicable.

Job Responsibilities

• Prepares working plan for assigned projects and provides timeline to Manager.
• Develops stability indicative analytical methods for drug substance and finished product.
• Identify and resolves analytical method problems as required.
• Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems.
• To review and approve regulatory submission documents like standard operating procedures, protocols, reports and calibration/qualification documents for the instrument/equipments etc.
• Ensures the quality of documentation & test results generated in the team.
• Applies AQbD approach to analytical method development where applicable.
• Responsible for protocol preparation, planning, execution, review and report preparation of various analytical method validation parameters.
• Ensures analytical methods validation is conducted according to approved validation protocol in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines.
• Responsible for method verifications and publishing of analytical methods.
• Maintenance and archival of analytical method validation documents.
• Responsible to ensure and monitor all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation.
• Responsible to ensure and monitor all analytical tests for PE/PO samples, including assay, degradation products and dissolution.
• Responsible to ensure and monitor all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing.
• Initiating QMS activities in QMS trackwise.(LIR,Deviation etc)
• Conducts lab investigations for LIR and Deviation.
• To prepare General, Operation and Calibration Standard Operating Procedures.
• Raising Change control for various analytical activities by QMS trackwise.
• Perform Training need analysis and create on-demand GxP training courses/programs and ensure timely and effective training solutions are in place to address imminent training needs.
• Imparting training to department and cross functional departments. Identifying individual training requirements, co-ordination for ARD personal.
• Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor.
• Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes.
• To participate in the mandatory trainings to execute the day to day job responsibilities.
• Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time.
• Practice and up-gradation of knowledge with respect to cGMP.
• Work as a member of a team to achieve all outcomes.
• Participates in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GMP requirements.
• Ensures all instruments assigned with responsibility within group/department are well maintained.
• Responsible to ensure and monitor the calibration of instruments in Analytical R&D and ensures the compliance as per cGLP requirements.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage and Innovation.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. 
• All other relevant duties as assigned.

Job Requirements

• Education
  • A graduate/Post-graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
• Knowledge, Skills and Abilities
  • knowledge of the instrumentation such as HPLC, GC, spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques.
  • Knowledge in HPLC method development and method validation.
  • Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports.
  • Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities
  • Should possess troubleshooting knowledge on Instruments and analysis.
  • Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
  • Working knowledge of LIMS is an asset.
  • Good written and verbal English communication skills
• Experience
  • Minimum of 7-10 years of experience in method development and validation in pharmaceutical industry.
  • Extensive knowledge and experience in analytical chemistry.