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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 proteins & peptides, oligonucleotides, iron formulations, 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 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 (biophysics, biochemistry or equivalent discipline) with 0 to 5 years of experience with spectroscopic and biophysical methods, including CD, FTIR, fluorescence spectroscopy.
Key technical skills:
- Competency in the acquisition, processing and data analysis by CD, FTIR, and fluorescence spectroscopy for analysis of proteins and peptides for regulatory submissions is mandatory
- Expertise in computational chemistry, molecular modeling and statistical methods are beneficial attributes.
- Basic understanding of working principles of liquid chromatographic methods, dynamic light scattering, AF4-MALS, SV-AUC, & related orthogonal methods to assess protein higher order structures
- 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
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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