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Candidate Info
6
years in workforce
6
years at this job
MS
Physical Chemistry
Analytical Scientist
- Conducted routine comprehensive testing including pH, acidity, texture and other physical metrics. Tracked and prioritized testing procedures to maintain efficiency and reduce downtime. Conducted quantitative analyses on Vitamin C and sugars to ensure accuracy of all label declarations.
- Received specialized training to serve as internal auditor. Evaluated process-based metrics including the calibration and maintenance programs for equipment, proactively verifying fulfillment of all ISO-related requirements. Facilitated the overall restructuring of analytical department to comply with ISO standards. Collaborated with personnel on identifying key areas to improve change management, PPE, laboratory storage and other critical responsibilities.
- Corresponded with Material and Recipe Management department to implement and verify compliance tactics. Cooperated extensively with product developers to analyze quality standards, legal requirements and other requirements to ensure the successful roll-out of new products to global markets. Reviewed exceptional release plans to mitigate complications and maintain adherence to quality standards.
- Championed the development and implementation of multiple testing methods. Designed testing process to conduct in-house vitamin analysis. Reviewed all company requirements and identified key opportunities to adapt current resources for new program. This led to the significant reduction of more than $100K in expenses.
- Designed and implemented new method for texture testing. Reviewed possible measures to determine efficacy in testing age-related metrics for diverse product ranges. Utilized in-house statistical analysis tools, as well as Minitab to facilitate measurements and determine key areas to optimize products.
- Generated spreadsheets and other documentation to track turn-around-times (TAT) and maximize efficiency. Utilized Microsoft Office Suite, Visual Basic and other programs to track samples, prioritize testing projects and tabulate completion times. This led to significantly improved cross-departmental communications among product developers and enhanced TAT from 80% to more than 95%.
Candidate Info
22
years in workforce
8
years at this job
PhD
Physics
PhD
Thesis Title
ANALYTICAL SCIENTIST IV ─ MATERIALS DEVELOPMENT LABORATORY
Analyst and manager of XPS, XRD, WDXRF operations. Performed R&D in solar devices and industrial metrology.
- Designed methods of XPS, XRD and WDXRF analyses of photovoltaic devices. Optimized thin film deposition.
- Detected and described detailed crystallographic phases and diffusion present in photovoltaic devices.
- Measured valence band offsets in photovoltaic heterojunctions by XPS/UPS/IPES.
Candidate Info
9
years in workforce
2
years at this job
BA
Science
MS
Medicinal Chemistry
Analytical Scientist (aerosol)
- Develop with additional team members a robust Phase 2 ready multi-dose dry powder inhaler device with multiple candidate API's through experimental design (DOE) studies.
- Characterize dry powder inhaler aerosol performance for aerodynamic particle size distribution (APSD) via Next Generation Impactor (NGI), Delivered Dose Uniformity (DDU), and simulated human breathing studies to support product/device development.
- Completed analysis and prepared data summaries of aerosol performance studies using Copley's CITDAS software and MS Excel.
- Analytical support of ongoing studies by HPLC.
- Train new scientists on lab testing and practices.
- Prepared and reviewed test summaries and technical reports for R&D study protocols.
- Authored SOP and working instructions.
Candidate Info
21
years in workforce
5
years at this job
PhD
Immunochemistry, Microbiology
Analytical Scientist / Senior Microbiologist
- Performed analytical method development for the API of ophthalmic delivery device
- Performed testing of in-process and final products using HPLC and UV/VIS
- Analyzed the in vitro release profiles of biodegradable ophthalmic drug delivery devices
- Participated in the stability testing of the drug product
- Investigated antibiotics in vitro and performed microbiological support of animal studies
Candidate Info
23
years in workforce
11
months at this job
BA
Biochemistry And Molecular Biology
Analytical Scientist
Analyze oral care GMP/Stability samples using various analytical instruments and SOPs
- Document and report analytical data per [company name] procedures and cGMP regulations
- Maintain awareness of regulatory and cGMP requirements relevant to job responsibilities
- Operate, maintain, and troubleshoot analytical instruments
- Participate in out-of-specification investigation and provide recommendations to overcome technical difficulties and promote continuous improvement
- Use OpenLab and Tiamo software to analyze several oral care formulations undergoing aging studies, reporting results in Labnet to move formulations from bench top to commercialization
Candidate Info
7
years in workforce
1
year at this job
BS
Chemistry
MS
Analytical Chemistry
PhD
Chemistry
Bioanalytical Scientist
- Bioanalytical support for drug discovery and development projects.
- Bioanalytical assay development and analysis of novel small molecule compounds in multiple tissue matrices such as plasma, tumor, muscle, etc, from PK and PK/PD experiments.
- Monitoring stability of compound in different conditions in different matrixes at different time points.
- Using LC/MS/MS AB Sciex (API-4000, APIQTRAP 5500 and API-6500) technique. Sample preparations using Tecan and TissueLyser for solid tissues, and sample analysis was done using Multiplex LC System using Watson LIMS. Proficient at documenting data and maintaining detailed reports in electronic lab notebook (ELN) using Aria software.
- Pursuing education in an advanced certificate course in Indian classical music.
Candidate Info
2
years in workforce
6
months at this job
BA
Pharmacy
MA
Science
Associate Analytical Scientist
Responsible for Evaluation, Revision, Modification, Creating of Testing Protocol and Method as per requirements.
- Responsible for Method Development and Validation of finished product, stability product as well as supporting testing and approving release product, reference material qualification, product development and MAD using of HPLC (TOTALCHROM), UPLC(CHEMSTATION), LIMS and UV-Spectrophotometer(CHEMSTATION), Colorimeter (DSC), PH meter, USP Dissolution Apparatus I & II, Auto sampler Dissolution Apparatus, Analytical Balance, Potentiometer, IR-Spectrophotometer, PSD Sonic Sifter, Karl fisher.
- Analyzing and interpreting validated and developmental Data using Compliance wire, CDMS, Track wise.
- Reporting and presenting reports and preparing product license documentation such as Protocol, Testing Method, Certificate of Analysis, summary report
- Managing onsite chemical inventory.
- Handling Routine laboratory Inspection and maintaining laboratories.
- Working by following Standard Operating System (SOP), EP, USP, FDA requirements and with Strong GDP, CGMP & CGLP, GxP environment and EHS standards.
- Working following Strong OSHA regulations for General Industry (OSHA 500)
- Working with ISO7/8 environment, FDA regulations.
Candidate Info
2
years in workforce
9
months at this job
BS
Chemistry
Analytical Scientist
- Execution of release and stability testing for both in-process and finished manufactured products
- Ensures analytical instrumentation such as HPLC, USP Apparatus I, GC, Karl Fischer titrator, and moisture meter
- Analysis of data using sophisticated (Empower) and general purpose (Excel) software
- Maintenance of all records and lab notebooks
- Oversight of an internship fellow: Interviewed and selected a candidate from the Northeastern Co-op Program for a winter internship, trained more junior resources
Candidate Info
14
years in workforce
9
months at this job
BS
Biology
Analytical Scientist Ii- Analytical Development
Manage projects involving method transfer, validation and development for topical pharmaceutical and OTC products. Communicate regularly with management and clients updating them on project status.
- Develop and evaluate methods for topical pharmaceutical and OTC products utilizing multiple technologies.
- Validate and transfer analytical methods.
- Analyze pharmaceutical products for developmental stability.
- Review analytical methods and data generated by peers.
- Identify technical problems during development, validation and transfer.
- Direct communication with clients.
- Review technical reports for accuracy and completion.
- Comply with SOPs, departmental procedures, and cGMP guidelines.
- Perform tasks in compliance with GMPs, FDA and ICH guidelines.
Candidate Info
32
years in workforce
4
years at this job
BS
Biology And Chemistry
MS
Analytical Chemistry
Analytical Scientist
- Principal scientist conducts, assesses and documents analytical tests in accordance with recognized rules of pharmaceutical practice and cGMP.
- Conducts independent development, validation, checking and assessment of analytical methods. Introduces new analytical methods and procedure.
- Creates, checks and assesses documents (stability protocols and reports, method development protocols and reports, method validation protocols and reports, SOPs, laboratory qualification protocols and reports, etc.).
- Trains colleagues in equipment and methods in accordance with qualification plan.
Candidate Info
3
years in workforce
9
months at this job
BS
Earth Science
MS
Analytical Chemistry
MS
Environmental Science
Senior Formulation Analytical Scientist
Maintain a working knowledge of cGMP, DEA requirements and FDA guidance documents.
- Accomplish feasibility studies on potential projects in coordination with Business
- Write analytical methods, SOPs, protocols and validation reports for the analysis of tablets,
- Manage all technical aspects of analytical chemistry to support the product development
- Review instrument IQOQPQ protocols and SOPs.
- Transfer, develop, and validate analytical methods and specifications.
- Create and review the specifications of Raw Materials, In Process Products, Finished
- Analyze Raw Materials, In Process Products, Finished Products and Stability Samples and monitor, evaluate and summarize analytical results in support of development projects.
- Supervise/train associate analytical scientists and technicians to ensure their activities
- Supervise/train associate analytical scientists and technicians to troubleshoot and review
Candidate Info
3
years in workforce
11
months at this job
BS
Mechanical Engineering
Packaging Analytical Scientist II
- Analytical lead on small sparkling package project
- Subject matter expert on PET authorization tests
- Train and manage technicians on routine analytical testing
- Implementing new database system to increase workload capacity and minimize data errors
Candidate Info
23
years in workforce
3
years at this job
BS
Chemistry
Analytical Scientist, R & D
- Performs analysis of finished products, validation samples, in-process materials and raw materials, according to the effective protocols, Methods and Compendials
- Collaborate developing new analytical methods or modifies current methods, able to participate in method transfers and assist with developing transfer protocols.
- Verifies co-workers calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data.
- Prepares reagents, standards, medias, etc. needed for analysis. Performs testing in compliance with cGMP and current safety regulations.
- Provide training to new or existing personnel
- Collaborate with the LIMS system as template specialist.
- Support QC and Analytical R&D DEA system.
- Completes any other duties assigned by QC and Analytical R&D management as required. Work on special projects as needed.
