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6-10 years of experience
- 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%.
6-10 years of experience
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.
0-5 years of experience
- 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.
0-5 years of experience
- 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
0-5 years of experience
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
0-5 years of experience
- 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.
0-5 years of experience
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.
0-5 years of experience
- 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
0-5 years of experience
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.
0-5 years of experience
- 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.
0-5 years of experience
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
0-5 years of experience
- 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
0-5 years of experience
- 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.
Analytical Scientist Duties and Responsibilities
Being an analytical scientist involves several different duties and responsibilities. We scoured online job postings to identify the following responsibilities that are common among all analytical scientists:
Develop Analytical Methods In response to changing requirements during product development, analytical scientists design new analytical methods or refine existing ones, then validate these for official use. Alternatively, they may participate in method transfers, where they use methods that originated from other laboratories.
Conduct Testing It’s the job of analytical scientists to conduct comprehensive rounds of testing on raw materials as well as in-process and final products. These may include stability, UV/VIS, dissolution, HPLC, and physical tests, which check for composition, physical and chemical properties, and behavior over time.
Evaluate Data Analytical scientists gather and document experimental data using lab notebooks and specialized software. Afterwards, they perform statistical analysis on these and interpret the results, relaying their findings through summary reports, technical documents, and even formal presentations.
Manage Inventory In order to meet project deadlines, analytical scientists manage the laboratory inventory, monitoring stock levels and procuring reagents, standards, and other necessary lab supplies. Likewise, they ensure that equipment is in good working order by calibrating these, checking for accuracy, and making minor repairs.
Maintain Compliance The chemical and pharmaceutical industries require strict adherence to standards, and analytical scientists keep abreast with these, constantly assessing company procedures and enforcing compliance with departmental rules, regulatory requirements, and GMP (Good Manufacturing Practice) guidelines.
Analytical Scientist Skills and Qualifications
Analytical scientists possess strong technical acumen and problem-solving skills, along with excellent hand-eye coordination for handling laboratory instruments. Companies that hire analytical scientists look for a degree in chemistry, pharmacy, or a related field and the following abilities:
- Chemistry knowledge – at the very least, analytical scientists formally studied chemistry for at least four years, so they possess in-depth knowledge of the subject. They are well-versed in both theory and practice and are interested in pushing the boundaries of research
- Critical thinking – analytical scientists must be able to analyze and interpret data accurately and apply the results to help create new products or procedures. They must also have the creativity to find solutions to obstacles and technical issues
- Attention to detail – being precise is extremely important for analytical scientists, who should follow standard procedures and record data accurately if they are to hold successful tests and experiments
- Collaboration – analytical scientists often coordinate with suppliers and function within a research and development team, where they exchange findings with engineers and other scientists, so they must have good communication and teamwork skills
- Technical writing – it’s essential for analytical scientists to be comfortable with technical writing, since they log all of their experimental data and prepare reports and procedural documents
Analytical Scientist Education and Training
Analytical scientists need to have a bachelor’s degree in chemistry, pharmacy, biochemistry, or a related field, and some employers may even require a master’s degree. Since many of their tasks are extremely hands-on, analytical scientists must have gained expertise through at least one year of experience in an FDA-regulated research or laboratory environment. On-the-job training involves learning new lab techniques that are specialized to current projects, and they should keep their knowledge up-to-date by constantly pursuing learning opportunities.
Analytical Scientist Salary and Outlook
The median annual salary for analytical scientists is around $66,000, according to PayScale. The lowest ten percent of earners receive less than $46,000 every year, while the highest ten percent earn more than $87,000. Industry employment for chemists, a sector that includes analytical scientists, is expected to grow by six percent from 2016 to 2026. The Bureau of Labor and Statistics (BLS) classifies this as an average rate and attributes it to the increase in scientific research and development, and the need for product validation and quality control in manufacturing.
Helpful Resources
Are you ready to become an analytical scientist? Here are some resources that you might want to look through:
The Analytical Scientist – this interactive, digital magazine is geared towards analytical scientists from all industries and features informative interviews, commentaries, news updates, and research summaries in an easy-to-read format. Website visitors can further access equipment profiles and a yearly power list of top 100 people in analytical science
Analytical Techniques in the Pharmaceutical Sciences – to undertake pharmaceutical design and development, analytical scientists must know a drug’s individual components, how these interact, and how the drug as a whole reacts to different environments. This textbook describes analytical techniques for understanding each of these
American Chemical Society – with more than 150,000 members worldwide, ACS is the largest science-centric society and welcomes all chemistry practitioners, whether students, professors, or professionals. It lays claim to an impressive number of publications from Nobel Laureates and scholarships, and members can access career tools and journal discounts
Statistics and Chemometrics for Analytical Chemistry – this book established a solid foundation in statistics for those studying analytical chemistry, covering mathematical methods, concepts such as sampling uncertainty, and the experimental design process
American Association of Pharmaceutical Scientists – AAPS caters to scientists in the pharmaceutical industry, including biologists, analytical scientists, and engineers. Members can join focus groups for specific disciplines, access journals and magazines, and receive networking and employment opportunities
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Analytical Scientist
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
