Research scientist I

Job Description

This individual will be responsible to perform routine analysis ,method development , validations and transfers to manufacturing site. Has the Advanced knowledge to handle analytical techniques independently but not limited to (HPLC,GC ,IC KF , UV , Osmometer , IR ,Zetasizer etc.). This individual will work with minimal supervision to support analytical activities which are conducted inhouse as well as at contract research lab.This individual can also review the analytical data based on the need.Perform the analytical method development, validation and transfer as well as prepare and review the associated protocols and reports. Responsible for day-to-day management of analytical activities. Proactively identify and address issues that arise during routine analytical testing. Create documentation, including investigations, change controls, analytical test methods and study protocols. Responsible for compiling and performing trend analyses of data as well as presenting data and results to support product development decisions. Actively contribute in preparation of specifications for drug substance and products. Provide guidance and support to internal groups as well as to outside CROs to ensure that analytical tests are conducted in compliance with all applicable procedures. Maintain and support a safety and quality culture. To ensure timely completion of assigned Training Modules and Skill Evaluation.M.Sc. Chemistry / M. Pharm with 7 -12 years of experienceAbility to effectively collaborate across all functions of the business so as to ensure consistent and timely achievement of project related goals.Takes a proactive approach in identifying team needs and provides appropriate support.Efficiently and effectively administers resources allocated within his/her area of competence, and proposes enhancements to processes and procedures to increase efficiency and effectiveness, consistent with the Pfizer s regulations.Good analytical development background including AQbD and hands on experiences with working knowledge of chemistry, analytical or pharmaceutical science.Understands and applies the industry specific standards/ regulations e.g. cGMP, Environmental, Health and Safety etc.Lab Management - Has in depth understanding of the lab activities and verifies the assigned task.Should have thorough understanding of GMP / GDP and identifies the gaps and participate in remediation.Significant relevant analytical working knowledge of HPLC/UPLC, GC, IC, UV, FTIR and other analytical equipment.Good analytical development background including AQbD and hands on experiences with working knowledge of chemistry, analytical or pharmaceutical science.Carries out peer reviews of work performed by colleagues.Acts as a technical resource within own work group/project teamRecognized as a technical expert with growing scientific contributions.May use or develop novel processes or hypotheses; new ideas and knowledge are used frequently.When managing projects, weighs advantages of choices and takes decisions by prioritizing the activities to be implemented, evaluating the use of resourcMakes insightful and timely decisions on complex issuesTakes into account potential changes and proposes mitigation and contingency plans.Decisions frequently impact whole work group/project team.Consults with supervisor/manager and seeks advice in examining unclear professional issues so as to evaluate options and take effective decisionsUses his/her own scientific judgment to apply and adapt standard methods and techniques by applying prior work experience, consulting others appropriately.Receives instructions primarily on unusual or complex problems.Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Research and Development #LI-PFE,

Keyskills :
environmental impact assessmentanalytical method development