Research Associate II

• Represent Global R&D Analytical on project teams as a key part of the project teams goals and success.
• Develop and execute analytical plans for new product development (NPD) and sustaining product projects (SPO)
• Execute lab activities related to analytical method development, validation, and transfer of methods to within/other R&D/manufacturing sites to support business needs.
• Ensure laboratory compliance and follow best practices.
• Represent R&D Analytical as member of project teams. Actively participate in success of project team goals
• Identifies and plans for all analytical resources needs capabilities and capacity required for the execution of the analytical strategy plan.
• Support and lead the analytical transfer plan globally to manufacturing plants, CRO and other RD centers.
• Without assistance, make sound technical recommendations regarding analytical method validation, transfer and testing that are more routine than not. Provide some analysis/redesign of key experimental procedures. Independently select techniques and procedures to solve problems within area of responsibility.
• Employ appropriate techniques/methods to execute routine analytical activities successfully and independently within negotiated deadlines. Identify alternative methods and technologies for improving existing or new products/processes.
• Act as a study director for these designs and execute method validation and transfer studies.
• Perform analytical gap assessment of in-use analytical methods and provide strategic action plan to remediate.
• Contribute to technical feasibility analysis of complex research and design concepts, execute studies such as development, validation, and transfer of analytical methods as on when required. Support analytical problem-solving efforts to meet urgent business needs.
• Prepare and review analytical documents (Validation / Transfer / Development protocols/reports, special reports) in compliance with analytical methods, global and local procedures.
• Contribute to Analytical sections intended for submission to regulatory authorities and responses to authorities.
• Demonstrate the ability to identify risks, issues, and opportunities.
• Support the analytical problem-solving efforts to meet urgent business needs and contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Support and prepare investigation plan for validation/transfer failure, OOS, deviations, and Incidents. Leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles.
• Demonstrate the ability to identify risks, issues, and opportunities.
• Collaborate with other global functions, such as project management, regulatory, formulation, manufacturing, external supplier, external partners, and quality control in project teams to ensure successful execution of analytical testing and study designs.
• Maintain knowledge of relevant QSR and safety requirements while building knowledge of other regulatory requirements related to R&D (product development, design, and safety) to ensure compliance in all research, data collection and reporting activities.
• Demonstrate ability to contribute and apply technical theories and principles to projects within area of expertise beyond own scope of responsibilities to ensure project milestones are met. Analyze and determine best solutions to non-routine experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications.
• In addition to having an in-depth knowledge and understanding of current regulatory guidelines, cGxP and related regulations and guidance, can provide expert advice and/or is an active participant in the generation, review, adoption and interpretation of such regulations. Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Coach and mentor junior members working in analytical activities not limited to methods development, validation, transfer, and gap assessment.
• Co-ordinate with technical lead/study director to execute a series of study designs and/or technical tasks that may not be well-defined, have multiple variables, and require advanced techniques within negotiated deadlines.
• Ownership of analytical methods, testing procedures, standard operating procedures and laboratory analytical instruments as applicable.
• Develop budgets and activity schedules of limited scope.
• Provide expert support within and across team as on when required.

• Experience with analytical method development, validation, and transfer.
• A good understanding of ICH, Ph. Eur, USP guidelines and cGxP practice.
• Familiarity and hands-on experience with HPLC, GC, Potentiometer, UV, AAS, FES, Empower and other analytical instruments and software.
• Ability to learn quickly and to solve problems in a timely manner using analytical chemistry skills.
• Ability to organize, assess and communicate complex information that engages the audience.
• Ability to make decisions when provided with limited information and to make routine decisions independently.
• Ability to design experiments and draw meaningful conclusions from lab data.
• Experience in working in global cross-functional teams across multiple time zones.
• Ability to adapt to changes and to work in a team environment.
• Ability to identify and solve technical issues.
• Good communication skills and having multi-tasking ability.
• Must possess strong verbal and technical writing skills.
• Having critical mind and scientific curiosity.
• Ability to manage different priorities, deadlines, and conflicts.

Education: Master s in chemistry or Pharmaceuticals, with 7 to 10 years of experience