Pr. Scientist/ Team Lead(Analytical Development-Complex Injectable)R&D

Conteúdo do emprego

Roles and Responsibilities

Candidate should have experience in analytical method development, testing and validation with focus on Pharmaceutical Complex injectable dosage form. Exposure to various dosage forms in injectable like, Liposomes, Microspheres, Emulsions, Lyophilized form & Suspension for injections. GMP/GLP environment and documentation procedures required.

• In depth understanding and knowledge about method development, method validation and method transfer for injectable products like, Liposomes, Microspheres, Emulsions, Lyophilized form & Suspension for injections.
• Already having leadership experience of handling a group of analytical scientists in a Analytical dept. for Generic Pharmaceutical product development and can independently handle the Analytical team and accountable to all analytical related queries by different regulatory agencies and management.
• Having prior experience and involvement in Analytical Lab set-up activities.
• Accountable to all analytical related queries by different regulatory agencies and management.
• Candidate must have experience for instrument/ equipment installation, operation & performance qualification.
• Responsible for preparation and review of SOPs, protocols, reports, policies etc in ARD Lab.
• Supporting analytical laboratory for maintaining high standards of safety.
• Having experience of handling of analytical team members and good inter-departmental communications are required.
• Maintaining analytical department for real time ready situation for internal as well external audits.
• Planning and monitoring of projects for analytical activity from project feasibility stage to commercial.
• Mentoring scientists for method development of complex Injectable generic products exclusively for complex parenteral dosage forms.
• Coordination with formulation department for various analytical activities.
• Coordination with External parent companys analytical / QC laboratory for all required activities
• Monitoring method validation activity and review of documents.
• Preparation of Standard operating procedures, Guidelines & specifications as per regulatory requirements.
• Understanding regulatory queries and providing scientific justifications, as and when required.
• Review of regulatory submission documents for adequacy.
• Participating in investigation of OOS, OOT, LIR and incidents and providing scientific CAPAs.
• Proficient in Chromeleon software, Waters empower software, chem-station and ELN software.
• Ensuring data integrity for day to day activities.
• Ensuring development activity for rugged, robust, cost effective and QC friendly methods using QbD approach.
• Preparation and review of Analytical method development report for related substances, dissolution and for sameness tests.
• Preparation and review of Method validation protocols as per ICH guidelines and summary report.
• Method development, validation and technology transfer experience of complex Injectable generic products for parenteral dosage forms and oral dosage forms is added advantage.
• Having capability of designing experiments on appropriate analytical techniques which are suitable and adequate for product development.
• Designing, Planning and execution of Formulation analytical activities during POC, optimization, validation stage.
• Review analytical data generated by scientist for completeness and adequacy.
• Preparing the development reports and organizing the data required for technology transfer team.
• Co-ordination with Formulation development and providing analytical support as per the project requirement. Analysis of results and discussion with the formulation team during the product development.
• Interaction with inter department for regulatory filing requirements.
• Expertise in scientific method development and validation as per regulatory guidelines.
• Respond to regulatory deficiencies on time.
• Identify the training needs of the team and implement effective training calendar for all the team members.
• Experience of generic product development and troubleshooting for regulated market is preferred.
• Experience in reverse engineering for RLD component is required.
• Good communication and Coordination skills and ability to work with a diverse cross-functional teams.
• Good analytical data interpretation skills and report writing skill with creative thinking ability.
• Maintenance of reference standard, working standards, impurity standards and their standardization.
• Develop appropriate HPLC and other methods for identified of certain projects from time to time
• Review of analyses of samples as per monograph / in-house procedures including reaction monitoring.
• Execute projects as per the approved test protocols if assigned on predefined timeline.
• Ensure that the calibrations of the equipment’s are performed as per the schedule.
• Indent the required glass ware, chemicals and columns for the ARD projects.
• Maintain GLP & implement safety procedures while working in Lab.
• Knowledge about the handling and calibration of all analytical instruments like HPLC, GC, UV, Dissolution, IR, Particle size analyzer, DSC, Osmometer, viscometer etc.
• Knowledge about the calibration of HPLC, GC, UV, SOR, IR, Particle size analyzer, Osmometer, viscometer etc.
• Knowledge about regulatory guidelines and requirements.
• Knowledge about method transfer activities.

Desired Candidate Profile

PG: M.Sc. / M Pharm

Doctorate: PhD (Analytical chemistry/ Organic chemistry)

Perks and Benefits

As per Industry standard