Research Assoc I, R&D - Complex Product Development (Characterization)

Baxter International · Ahmedabad · onsite · Posted 56d ago

Undisclosed6–10 yrsfulltimeSourced from Naukri

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About this role

Job Summary

The person will be responsible to undertake computational and experimental studies on complex injectable drug products performed at Complex Product Development, Research Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and other RD sites as and when required

Responsibilities

Quality:

To perform advanced characterization of complex injectable drugs, including proteins peptides, oligonucleotides, iron formulations, carbohydrates other biomolecules in lyophilized, liquid, emulsions other formulations by computational methods for regulatory submission following GLP norms.
To manage outsourced studies at CROs, academic institutes other external facilities, from study design, execution, analysis and report preparation. Traveling to external facilities, as and when required, is a mandatory requirement for this position.
To demonstrate subject matter expertise and help overcome technical challenges in product development, by liaising with formulation and other cross-functional teams as a Subject Matter Expertise (SME).
To understand the project with guidance of Sub-department Manager and follow their instructions.
To provide necessary assistance for various procurement activities, review quotations, engage suppliers to procure required goods services in a timebound manner
To complete the planned work in the stipulated time frame, inform the Sub-department Manager if any deviation or issues are observed.
To keep track of each activity related to product analysis and development activities.
To carry out all the testing and data recording according to the approved SOPs/ ALCOA++ principle and current pharmacopoeia. Data recording in ELN and sign off must be completed on time.
To verify the shelf life of the chemical or reagent before performing analysis of the material or product.
To follow Good Documentation Practices Good Laboratory Practices, maintain lab notebooks other records appropriately.
To investigate if any deviation / abnormalities are observed and report to Sub-department Manager.
To check the trend of results before reporting the results.
To keep the status of daily work and report to Sub-department Manager on daily basis.
To undertake operation, calibration, preventive and breakdown mainte the instruments as per approved standard operating procedure. To report on the conclusion of preventive maintenance and breakdown maintenance to Sub-department Manager.
To list all resources required for the study and keep track of routine requirements and ensure timely procurement of the same, verify the materials received for analysis from supplier as per given requirement.
To complete training as per the quality matrix targets.
To prepare and update the SOPs. To prepare method development and verification report.

Administrative:

To perform the work as allocated by Sub-department Manager.
To liaise with customers, staff and suppliers.
To write / fill the record in legible writing.
To keep the documentation online with analysis.
To compile required data for Management Information System and provide to Sub-department Manager.
In the absence of Officer, Sub-department Manager will ensure his roles and responsibilities.

Communication to the management / superiors:

To communicate about any failure or abnormal notification or non-compliance in results to Sub- department Manager and help resolve them in a timely manner
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 (Pharmacy, or equivalent discipline) with 6 to 10 years of experience, or, PhD (computational chemistry, biophysics or equivalent discipline) with 0 to 5 years of experience with computational chemistry, MD simulations, quantum chemical calculations, or related in-silico techniques

Key technical skills:

Deep expertise in computational chemistry, molecular modeling, and molecular dynamics simulations are mandatory requirements. Candidates with some experience in the usage of AI / ML tools to augment computational studies will be preferred.
Proficiency in data analysis, including the usage of statistical methods for data interpretation are beneficial attributes.
Basic understanding and hands-on experience in some of the following routine analytical methods is highly desirable: CD, FTIR, fluorescence spectroscopy, particle size distribution by DLS, etc
Proficiency in literature search through publication and patent databases, repositories (e.g. Pubmed), scientific webinars by regulatory agencies, etc, to remain updated on advanced characterization methods and recent scientific developments.
Knowledge of pharmacopoeia, ICH Guidelines and means to implement them for product development.
Experience in the operation, calibration and preventive maintenance of NMR and other instruments to ensure continued usage
Trouble shooting of various problems obtain during the product development

Disclaimer: This job posting and Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Sourced from naukri

Skills

Data InterpretationBreakdown MaintenancePeptidesftirChemistryMethod DevelopmentcharacterizationPharmacycomputational methodsHealthcareLiteratureoperationsmaintenancePreventive Maintenancedata analysiscomplianceArtificial IntelligenceMachine Learning

About Baxter International

Baxter International

Healthcare

5k+

employees

1931

95 years old

Kolkata, West Bengal

India

₹20.4L PA avg

Avg at Baxter International

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Baxter hires a range of talented and driven individuals with diverse skill sets and backgrounds, from scientists and researchers to industry professionals in manufacturing, engineering and technology,

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