Analytical Scientist Resume Samples

Description :

1. Developed and validated analytical methods for GC, HPLC, UV Spectrophotometry, and TLC.
2. Ensured optimal performance of Agilent and Waters HPLC instruments through regular maintenance.
3. Validated a method for detecting organic solvents at trace levels using GC Headspace.
4. Conducted instrument qualification and performance qualification per regulatory standards.
5. Maintained compliance with cGMP and GLP, ensuring accurate documentation practices.
6. Managed Discrepancy Records to uphold quality assurance in product development.
7. Created analytical methods for non-UV chromophores using ELSD technology.

Experience

2-5 Years

Level

Executive

Education

MSc Chemistry

Description :

1. Prepared validation documents, method monographs, and protocols for analytical method validations and transfers.
2. Addressed FDA deficiencies and prepared CTD documents for ANDA submissions.
3. Executed method development and validation using GC, HPLC, and AAS techniques.
4. Conducted stability and release testing utilizing HPLC normal and reversed phases.
5. Developed and validated cleaning methods to support manufacturing processes.
6. Designed experimental plans to resolve analytical challenges effectively.
7. Performed routine analysis on raw materials and drug products using various instrumental techniques.

Experience

2-5 Years

Level

Executive

Education

M.S. Chemistry

Description :

1. Executed assays to analyze potency decay trends in topical formulations over extended periods.
2. Ensured compliance with GMP regulations while performing laboratory duties.
3. Interpreted complex data sets to identify significant trends and insights.
4. Consistently met strict deadlines while maintaining high quality and laboratory integrity.
5. Utilized effective time management strategies to balance multiple project deadlines.
6. Conducted peer reviews of data to ensure accuracy and completeness of testing.
7. Performed assays on unconventional samples, ensuring precision and reliability of results.

Experience

2-5 Years

Level

Executive

Education

Bachelor's Of Science

Description :

1. Provided analytical support for upstream and downstream process development, enhancing bio-molecule characterization.
2. Conducted formulation studies for polymer-based drug delivery systems, ensuring optimal content uniformity.
3. Developed and validated analytical methods for in-process control and final release using HPLC and GC techniques.
4. Ensured compliance with cGMP, cGLP, and FDA regulations, maintaining high-quality standards.
5. Created monographs for in-process samples, streamlining API synthesis documentation.
6. Executed chiral separations using advanced IR detection methods, improving analysis accuracy.
7. Conducted stability testing for production batches under various storage conditions, ensuring product integrity.

Experience

7-10 Years

Level

Management

Education

Bachelor's Of Science

Description :

1. Developed and validated LC methods for simultaneous determination of hydrolysis and fermentation products.
2. Created a UPLC method for amino acid analysis from feed-stock, enhancing accuracy.
3. Conducted fatty acid analysis using GC, ensuring compliance with quality standards.
4. Performed total protein analysis using a nitrogen analyzer, improving data reliability.
5. Established an assay method for phytic acid quantification, optimizing feed-stock evaluation.
6. Calibrated and maintained analytical instruments, ensuring precision in results.
7. Updated SDSs, SOPs, and laboratory notebooks, maintaining regulatory compliance.

Experience

2-5 Years

Level

Junior

Education

G.E.D

Description :

1. Conducted comprehensive analysis of product compositions, ensuring compliance with specifications and quality standards.
2. Utilized advanced wet chemistry techniques, including separation and titration, to achieve accurate results.
3. Trained and mentored junior staff on analytical equipment operation and data processing.
4. Regularly updated laboratory protocols to enhance testing efficiency and accuracy.
5. Implemented monitoring systems for laboratory equipment, ensuring adherence to ISO regulations.
6. Reviewed scientific literature to stay current with industry advancements and methodologies.
7. Maintained cGMP compliance and contributed to the introduction of innovative technologies in the lab.

Experience

2-5 Years

Level

Executive

Education

G.E.D

Description :

1. Conducted routine and non-routine laboratory testing of pharmaceutical products, ensuring compliance with GLP and GMP standards.
2. Maintained meticulous records and documentation, adhering to GMP, USP, and ICH guidelines.
3. Investigated out-of-specification results, effectively communicating findings to management.
4. Developed and revised SOPs and analytical specifications, ensuring alignment with current USP monographs.
5. Supported analytical method development, managing multiple projects to meet tight deadlines.
6. Utilized strong chemistry knowledge to troubleshoot product and process issues effectively.
7. Oversaw all stages of method development, including successful transfer to Quality Control.

Experience

2-5 Years

Level

Executive

Education

Bachelor Of Science

Description :

1. Established work priorities and ensured timely completion of assignments while mentoring new hires.
2. Conducted sample preparation and physical testing, including viscosity and density assessments.
3. Developed and validated new analytical methods in compliance with ASTM standards.
4. Interpreted complex data sets and authored detailed reports for management review.
5. Utilized advanced software tools for data analysis and documentation.
6. Acted as Laboratory Manager in absence, overseeing daily operations and staff performance.
7. Completed a 12-month project focused on stability testing of inhaler products in a GMP environment.

Experience

5-7 Years

Level

Executive

Education

Bachelor Of Science

Description :

1. Generated comprehensive technical reports and collaborated with QC for method validation and assay transfer.
2. Authored SOPs and protocols to support method development, ensuring compliance with regulatory standards.
3. Conducted routine testing of in-process and bulk drug samples to evaluate product variants and impurities.
4. Managed inventory of critical reagents, coordinating with shipping for timely distribution.
5. Completed extensive training in GMP practices, enhancing compliance and operational efficiency.
6. Executed analytical methods for inhaled products, including content determination and cascade impaction.
7. Assisted in the validation of new analytical methods, contributing to improved product quality.

Experience

2-5 Years

Level

Executive

Education

Bachelor Of Science

Description :

1. Conducted stability testing and clinical batch release testing, ensuring compliance with regulatory standards.
2. Performed data transcription and analysis for regulatory submissions using advanced statistical software.
3. Contributed to the development of analytical methods and risk assessments for product submissions.
4. Executed routine sample analysis to support product development, meeting strict timelines.
5. Collaborated with cross-functional teams to optimize critical process parameters for product formulations.
6. Assisted in the development of methods for drug delivery systems, enhancing product efficacy.
7. Participated in training sessions on Six Sigma principles to improve laboratory processes.

Experience

5-7 Years

Level

Executive

Education

High School Diploma