Associate Scientist II, R&D, Complex Product Development

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Summary:

The person will be responsible for the execution analysis and review of analytical work (method development pre-validation validation technology transfer and analysis of stability sample) performed at Complex Product Development team GPRD following GxP practices. The Person is also responsible to provide analytical support to Baxter Global and Baxters Contract manufacturing sites as required.

Essential Duties and Responsibilities:

To plan and perform sample analysis (analytical method development validation technology transfer etc) activity following GxP & GDP practices for regulatory submissions for complex injectables like peptides iron formulations etc. Assist in regulatory query responses for Complex Products.

To perform testing of Complex Injectable samples including API development validation stability bulk hold RLD PDR and any other samples as required according to appropriate method of analysis.

To be competent in analytical problem-solving focus on innovation process improvement and operational excellence. Knowledge of published literature and databases is essential.

To keep track of all activities related to product analysis ensure completion in the stipulated time and inform the Sub-department manager if any deviation or issues observed.

Preparation and review of analytical reports SOPs and MOAs by referring to GQP & current pharmacopoeia as per requirement.

To carry out all testing and data recording according to the approved SOPs following GDP & ALCOA principles and current pharmacopoeia. Ensure data recording in ELN with timely sign off and closure.

To use appropriate reference and working standards for analysis and maintain their records. To verify the shelf life of the chemical or reagent before performing analysis of the material or product.

To complete all training as per the quality matrix targets. To keep the status of daily work and report to Sub-department Manager on daily basis as per requirement.

To perform or review the calibration records of instruments as per approved SOPs. To check pre-requisites assist in installation and qualification of laboratory instruments in timely manner as per organization requirement.

To manage preventive & breakdown maintenance perform risk assessment and suggest immediate corrective actions as and when required. To report conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.

• To Report and investigate any failure / abnormal observation / OOT / OOS / deviation / Non-Compliance to sub-department manager and seeking for the solutions.

To list all resources required for the study keep track of routine requirements ensure timely procurement of the same and verify the materials received for analysis from suppliers.

To review stability program for finished product monthly data logger reports and qualification documents for stability chambers.

To ensure timely review of DMF of API vendors manage API and Excipient Vendor Approval process of New Product and existing products.

To review the status of daily work of the team and report to the Manager

Administrative:

To plan work schedule as per requirement by respective department.

To liaise with customers staff and suppliers.

To respond to the query in the stipulated timeline.

To ensure documentation is in line with analysis.

To monitor compilation required data for Management Information System and provide to Sub-department Manager.

To perform the documentation and QMS related activity using applications software like TCU Trackwise etc.

Communication to the management / superiors:

To communicate any failure deviation or abnormal notification or non-compliance in results to Sub- department Manager for their attention and work towards a solution

To communicate project related issues to Sub-department Manager and follow the action plan.

To keep status of daily work and report to Sub-department Manager on daily basis.

Qualifications:

Masters in science with 8 to 12 years of Experience

Key technical skills:

• Good experience in the execution of analytical method development validation and technology transfer and routine analysis for peptides and iron colloidal drug products for regulatory submission.

• Competency with method relevant to iron DS/DP analysis including particle size distribution by gel filtration chromatography light scattering/diffraction/obscuration methods assay of various iron forms e.g. ferrous ferric labile iron chelation assays reduction potential and kinetics etc is strongly desired.

• Basic Knowledge and execution of Chemical Analysis using techniques relevant to complex injectables

• Knowledge of pharmacopoeia ICH Guidelines.

• Execution of Operational and Calibration of Instrument on periodic basis

• Trouble shooting of various problems obtain during the during analysis.

• Knowledge of Transfer of Technology.

• Knowledge of Good Laboratory Practice and Good Documentation Practices

Key behavioral attributes:

Communication skills

Presentation skills

Analytical skills

Lateral coordination

Positive Attitude

Policy compliance

Documentation Skills

Problem Solving

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

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