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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 R&D sites as and when required
Essential Duties and 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:
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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:
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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.
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Proficiency in data analysis, including the usage of statistical methods for data interpretation are beneficial attributes.
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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
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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.
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Knowledge of pharmacopoeia, ICH Guidelines and means to implement them for product development.
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Experience in the operation, calibration and preventive maintenance of NMR and other instruments to ensure continued usage
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Trouble shooting of various problems obtain during the product development
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
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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