- *Req \#** 201201 **Location** Ahmedabad, Gujarat, India **Job Category** Research and Development **Date posted** 06/05/2026
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**Summary**
The person will be responsible for the execution of advanced characterization studies (including Method Development, Method Qualification, Sameness Study and Routine Analysis of complex injectables) performed at Complex Product Development, Research \& Development, Baxter Ahmedabad. The Person is also responsible to provide an analytical support to Baxter Global, and Baxter’s Contract manufacturing sites.
**Essential Duties and Responsibilities**
- To perform advanced characterization of **complex injectable drugs**, including **iron formulations**, proteins \& peptides, oligonucleotides, carbohydrates \& other biomolecular APIs and various impurities in lyophilized, liquid, emulsions \& other formulations 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 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 (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience in **SEC\-UV\-MALS and related methods encompassing liquid chromatography, light scattering, diffraction** and **light obscuration**
**Key technical skills**
- Competency in the acquisition, processing and data analysis by **SEC\-UV\-MALS** and **light scattering/diffraction/obscuration techniques for analysis of peptides and iron colloidal products** for regulatory submissions is mandatory
- Expertise in **computational chemistry, molecular modeling** and **statistical methods** are beneficial attributes.
- Basic understanding of working principles of biophysical \& spectroscopic methods, like CD, FTIR, UV, **EPR**, **Mossbauer**, and fluorescence spectroscopy, **particle XRD**, microscopy methods (AFM \& EM) \& related orthogonal methods to assess structural properties of proteins and iron colloids
- **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.
- Knowledge of good laboratory practices and good documentation practices
**Key behavioral attributes**
- Communication skills
- Presentation skills
- Analytical skills
- Lateral coordination
- Positive Attitude
- Policy compliance
- Documentation Skills
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