Scientist, Analytical Chemistry Resume Samples

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H Hartmann

Henry

Hartmann

98983 Opal Vista

Houston

+1 (555) 366 8634

98983 Opal Vista

Houston

Phone

p +1 (555) 366 8634

Experience Experience

Houston, TX

Scientist, Analytical Chemistry

Houston, TX

Ledner, Nicolas and Lowe

Houston, TX

Scientist, Analytical Chemistry

Perform routine assays and provide test results on an established deadline
Provide analytical support for formulation and process development
Proactively provide suggestions on how to improve methods, lab practices or lab systems
Analytical method development - planning, conducting and reporting experiments
Execute qualification of assays and draft qualification reports
Train and provide technical guidance to associate scientists
Perform sample preparation and post purification handling

Phoenix, AZ

Associate Scientist, Analytical Chemistry

Phoenix, AZ

Huel, Satterfield and Bergstrom

Phoenix, AZ

Associate Scientist, Analytical Chemistry

Assist in developing analytical methods to facilitate new drug development
Testing to support process and formulation development
Assist in conducting method validation experiments
Document all work processes according to GMP standards
Analytical method development and qualification
Writing SOPs and technical reports
Maintaining equipment calibration and preventative maintenance

present

Detroit, MI

Senior Scientist, Analytical Chemistry

Detroit, MI

Ullrich, Anderson and Batz

present

Detroit, MI

Senior Scientist, Analytical Chemistry

present

Authoring, reviewing and approving test methods, protocols and technical reports
Chromatographic Analyses including Process Related Residuals
Follow, understand and comply with AbbVie SOP’s and policies on cGMP’s and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas
Lead the analytical aspects of a project while working with other functional areas to advance projects through the pipeline
Serve as a liaison between functional groups and external customers for analytical development, transfer, troubleshooting and improvement efforts
Manage analytical projects. Establish schedules, define dependencies and project plans and direct activities of other scientists and non-scientists as well as provide training and development for others
Develop, validate, transfer and troubleshoot API analytical methods, including raw materials, in-process and API testing

Education Education

Bachelor’s Degree in Analytical Chemistry

University of Tennessee

Bachelor’s Degree in Analytical Chemistry

Skills Skills

Collaborates well with others and strong orientation towards team work
Prior experience working in an R&D lab
Demonstrate understanding of cGMP manufacturing for biopharmaceutical products
Have a bias for action and display a sense of urgency
Collate and present results in various forms, such as, technical reports and oral presentations
Interest in data tracking and trend charting
Experience in supporting all phases of API development, ideally spanning early development to registration
Familiarity with next generation sequencing
Experience with synthetic chemistry and analytical techniques
Demonstrates a sense of urgency, contagious optimism and a “can do” attitude

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Scientist, Analytical Chemistry Resume Examples & Samples

Analytical method development to assist in chemical process development and up to P1/P2 API GMP manufacturing activities in order to support GLP Tox and regulatory filings (IND)
Perform R&D analytical work to address chemical stability and structure elucidation
Perform forced degradation, stability studies and dissolution testing
Method qualification, method validation, impurity identification, and release testing of raw/starting materials, intermediates and API
Maintenance of analytical equipment including, calibration/qualification for GMP activities and system suitability testing
Writing of analytical reports, SOP's and IND sections

Senior Scientist, Analytical Chemistry Resume Examples & Samples

Lead the analytical aspects of a project while working with other functional areas to advance projects through the pipeline
Utilize understanding of a range of analytical techniques to conduct research and development related to small-molecule active pharmaceutical ingredients, intermediates, starting materials, impurities and impurity profiling
Support new product development with advanced methods development and validations, technical transfer packages, and generation of technical data in support of clinical API regulatory requirements

Scientist, Analytical Chemistry Resume Examples & Samples

Ability to follow laboratory procedures with attention to detail, and execute experiments at the bench independently
Strong ability to think critically, and demonstrated troubleshooting and problem solving skills
Develop a variety of analytical methods to characterize samples. Expertise must include (but are not limited to) cell culture and qPCR. Experience with ELISA, enzyme activity assays, and general molecular biology techniques (AGE, Southern, etc.) are a plus
Draft protocols for assays and lab procedures, and train additional analysts to perform these protocols
Execute qualification of assays and draft qualification reports
Perform routine assays and provide test results on an established deadline
Excellent data analysis skills. Proficiency in Microsoft Excel
Good interpersonal, verbal and written communication skills. Proficiency in Microsoft Word and Microsoft Powerpoint
Ability to function efficiently and independently in a changing environment
Experience managing a research laboratory or equivalent
Ability to lift over 30 lbs

Associate Scientist, Analytical Chemistry Resume Examples & Samples

Product characterization testing
Testing to support process and formulation development
Writing SOPs and technical reports
Maintaining equipment calibration and preventative maintenance

Scientist, Analytical Chemistry Resume Examples & Samples

Perform analytical activities including method development, transfer and validation as well as, IPC’s, cleaning verification, release testing of incoming materials, intermediates, API’s and reference standards
Perform R&D analytical work to address chemical stability and structure elucidation including forced degradation, stability studies and dissolution testing
Maintenance of analytical equipment including calibration/qualification and system suitability testing for cGMP activities
Significant experience in analytical method development for small molecules
Experience in supporting all phases of API development, ideally spanning early development to registration
Demonstrate understanding of cGMP manufacturing for biopharmaceutical products
Demonstrated success working effectively outside typical procedures when required
Have a bias for action and display a sense of urgency
Provide regular updates, documentation and communication of analytical development results to supervisor and development team, if needed

Scientist, Analytical Chemistry Resume Examples & Samples

Responsible for development and validation of analytical methods
Assist in quality testing of reagents
Interact within Chemistry R&D group as well as with Process Development R&D
Extensive documentation and report writing
BS or MS in chemistry, material science, physics, biochemistry or equivalent
Experience with analysis and evaluation of data sets
Must have a basic understanding of analytical chemistry and good lab practices
Capability to safely work with organic solvents and other hazardous materials
Ability to perform moderate to intensive pipetting and long continuous periods in the lab executing experiments
Interest in data tracking and trend charting
Familiarity with next generation sequencing
Experience with synthetic chemistry and analytical techniques
Demonstrates a sense of urgency, contagious optimism and a “can do” attitude
Collaborates well with others and strong orientation towards team work

Scientist, Analytical Chemistry Resume Examples & Samples

Will apply technical knowledge to develop consumables/reagent based products and to recommend product enhancements
Responsible for development of key analytical methods applied to complex matrices
Maintains an accurate and detailed lab notebook based on the scientific method enabling other scientists to reproduce their experiments
Will conduct experiments and/or evaluation of specific products
In some cases, develop a hypothesis and then design the necessary set of experiments to test the hypothesis with no assistance. Analyze the data derived and explain the outcome of their experiments. The proper negative and positive controls must be included
Has expertise with multiple specific scientific procedures and areas of research
Prepares regular reports documenting experiments
Presents research data and conclusions

Scientist, Analytical Chemistry Resume Examples & Samples

A minimum of a Bachelor Degree is required
A minimum 2 years of professional experience is required
Master Degree is preferred
A degree in Chemistry or closely related field is required
Applied experience with High-Performance Liquid Chromatography (HPLC) and Gas Chromatography (GC) are required
Experience with Ultraviolet-Visible Spectroscopy (UV-Vis), Fourier Transform Infrared (FTIR) Spectroscopy, wet chemistry and compendial techniques are strongly preferred
The ability to work in a team environment and to manage multiple deliverables with competing timelines is required
Experience working in a cGMP environment is strongly preferred
Prior experience developing methods is strongly preferred
Experience with semisolids (emulsions, creams, lotions and/or gels), medical devices, or combination products is preferred
Experience working on cross-functional teams with Analytical, Microbiology, Procurement, R&D, Supply Chain, Operations, Manufacturing or other functions is preferred
Experience with technology transfer of manufacturing products is preferredR&D

Principal Scientist, Analytical Chemistry Resume Examples & Samples

Develops analytical procedures and independently applies scientific knowledge (both theoretical and practical) for the resolution of analytical chemistry problems
Prepares method qualification, validation, and transfer protocols/reports
Performs method qualification, validation and transfer
Prepares scientific reports and documents
Presents analytical findings to teams and clients, and uses scientific literature to solve advanced technical problems
Reviews procedures and data generated by other analysts
Troubleshoots analyses and performs investigations
Participate in project management activities including creating and meeting objectives for timelines, budgets, and project goals
Contributes to the technical growth of the department and company
Interacts and communicates with clients
In depth knowledge of characterization processes and instrumentation, which may include, but is not limited to HPLC, UPLC, GC, MS, LCMS, NMR, IR, UV, DSC, TGA, XRPD etc
Excellent written, verbal and executive level presentation skills
Track record of scientific success as measured by publications, patents and presentations
Ability to prioritize and manage numerous projects simultaneously
Experience in building and managing scientific teams when needed
Knowledge of Mandarin is preferable, but not required
PhD in Analytical Chemistry with at least 5 years of industrial experience post graduate school
Industrial experience in analytical methods development, validation and transfer for Active Pharmaceutical Ingredients (APIs)
Excellent analytical, written and verbal communication skills
Experience with HPLC, GC, LC-MS, GC-MS, IC, spectroscopy, and wet chemistry
Ability to read, analyze, and interpret English-language scientific journals, and regulatory documents
Ability to write clear and concise technical reports, client correspondence and procedures
Ability to lead projects and provide direction to analysts and chemists when applicable
Ability to positively resolve conflictChemistry

Senior Scientist, Analytical Chemistry Resume Examples & Samples

Development, optimization and execution of analytical methods (IEC, SEC, RP, HIC, HILIC, iCIEF, CE-SDS)
Method transfer to QC and external partners
Authoring, reviewing and approving test methods, protocols and technical reports
Characterization of antibodies/ADCs for regulatory filings, comparability and PC/PV studies
Preparation and characterization of degraded materials
Serve as an analytical subject matter expert and resource for other departments

Senior Scientist, Analytical Chemistry Resume Examples & Samples

Responsible for method development, testing procedures, and implementation of analytical process controls to help the advancement of drug discovery candidates
Apply analytical separation and detection modes for complex impurity profiling of APIs and API precursors to further the understanding of emerging cGMP synthetic processes
Responsible for leading the analytical aspects of a project while working with other functional areas to advance projects through the pipeline
Utilize understanding of a range of analytical techniques to conduct research and development studies related to small-molecule active pharmaceutical ingredients, intermediates, starting materials, impurities and impurity profiling

Senior Scientist, Analytical Chemistry Resume Examples & Samples

Develop, validate, transfer and troubleshoot API analytical methods, including raw materials, in-process and API testing
Interpret analytical data, recommend specifications and methods for process or product characterization
Anticipate, recognize and resolve simple and complex technical issues through job knowledge, use of technical resources including technical literature and experts and well formulated, logical experimentation
Serve as analytical representative to cross functional project teams; actively participate in team efforts and contribute to technical evaluations and solutions
Author, review and verify validation and transfer protocols and reports
Author quality and regulatory test method documents
Write/co-author memos and scientific reports in support of Regulatory Submissions, Regulatory Field Alerts and support quality control and manufacturing documents
Manage analytical projects. Establish schedules, define dependencies and project plans and direct activities of other scientists and non-scientists as well as provide training and development for others
Serve as a liaison between functional groups and external customers for analytical development, transfer, troubleshooting and improvement efforts
Capable of working fully independently
Follow, understand and comply with AbbVie SOP’s and policies on cGMP’s and safety. Maintain a clean, safe and organized lab area, and potentially assume responsibility to ensure that others maintain their lab areas

Associate Scientist, Analytical Chemistry Resume Examples & Samples

Analyze pharmaceutical compounds using analytical techniques such as HPLC, dissolution and KF with limited supervision
Assist in developing analytical methods to facilitate new drug development
Assist in conducting method validation experiments
Follow methods and protocols in a GMP manner
Analyze data, present summary, and propose recommendations
Document all work processes according to GMP standards
Write organized first draft or memo or report
Accept additional responsibilities beyond normal daily responsibilities to meet departmental needs and goals

Associate Scientist Analytical Chemistry Resume Examples & Samples

Planning, organization, correct execution and documentation of the analytical tests under the guidance of an Analytical Expert
Development of robust analytical procedure, which can be successfully transferred to production
Maintenance of lab infrastructure and instruments
Working according to SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines
Participation in Analytical Network activities

Senior Scientist, Analytical Chemistry Resume Examples & Samples

Chromatographic Analyses including Process Related Residuals
Experience: 2 years’ relevant laboratory in experience in the bio/pharmaceutical industry required, with a focus on working in a GMP environment preferred
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
Other: Full understanding of regulatory requirements of study types assigned, as well as Testing Facility SOPs and Good Manufacturing Practices (GMPs). Effective written and verbal communication skills. Ability to handle multiple projects, prioritize work and meet deadlines. Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and with standard laboratory calculations and interpretation. Previous experience in a range of HPLC and other protein analysis methods are required. Knowledge and experience with CE and ELISA is a plus

Scientist, Analytical Chemistry Resume Examples & Samples

Subject Matter Expert in Analytical chemistry
Analytical method development - planning, conducting and reporting experiments
Method validation
Instrument qualification
Participate in production and quality control support activities
Interface with and coordinate collaboration with other departments in the organization
Minimum Master of Science within Analytical Chemistry
Knowledge in using statistical experimental design and data analysis tools
Fluent in both spoken and written English and a Scandinavian language
Experience with ISO-13485 and related requirements for analytical methods desired
Good understanding of a modern manufacturing organization
Experience from relevant industry
Track record of delivering results in the areas of quality, time and cost

Associate, Scientist, Analytical Chemistry Resume Examples & Samples

Conduct validated assays. Review analytical documentation to ensure compliance, accuracy and sound scientific judgment
Assist in and/or performs method development and validation with minimal supervision
Uses computer skills to compile and analyze assay results. Uses computer skills to locate / review data in ATLAS and eDocs
May assume responsibility or assist in writing analytical reports. Review supporting data for consistency (i.e. vs. raw data)
Performs analytical work in compliance with applicable regulations. Assures data generated is in compliance with applicable regulations

Scientist Analytical Chemistry & Mass Spectrometry Resume Examples & Samples

Develop and apply high resolution accurate mass (LC-HRAM-MS) methods for non-targeted screening of constituents and metabolites in a variety of different matrices
Perform characterization, identification and quantitation of small molecules in complex matrices using state-of-the-art mass spectrometric instrumentation
Perform non-targeted screening and apply metabolomics approaches on complex matrices
Work in a team to prepare samples and generate scientific data
Maintain, operate and troubleshoot high resolution accurate mass instruments and other analytical equipment
Write Standard Operating Procedures (SOPs), research protocols, study plans and study reports

Scientist, Analytical Chemistry Resume Examples & Samples

Independently development and validate analytical methods for drug substances and drug products
Conduct/manage routine and advanced analytical tests in accordance with SOP's and regulatory guidance
Provide analytical support for formulation and process development
Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings
Train and provide technical guidance to associate scientists
Troubleshoot analytical problems, conduct laboratory investigation and prepare laboratory investigation report
Proactively provide suggestions on how to improve methods, lab practices or lab systems
Experience overseeing work at external contract lab organizations is a plus

Scientist, Analytical Chemistry Resume Examples & Samples

Support drug substance process development including characterization of starting materials, intermediates and final API
Develop, optimize and validate analytical methods
Generate laboratory clinical release and stability data
Qualify/transfer analytical methodology to quality control and contract laboratories
Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities

Scientist, Analytical Chemistry Resume Examples & Samples

Isolate desired products from crude reaction mixtures (mg-g scale) with mass-directed purification systems (LC and SFC)
Troubleshoot and maintain analytical and preparative systems
Operate automated liquid handling systems and centrifugal evaporators
Handle electronic data, interpret results, and communicate with chemists
Perform sample preparation and post purification handling
Perform general laboratory logistics and ordering
Maintain accurate lab records and documentation
BS with a minimum of (5) years in Analytical Chemistry, Organic Chemistry or Chemical Engineering with industrial experience
MS with a minimum of (2) years in Analytical Chemistry, Organic Chemistry or Chemical Engineering with industrial experience
Experience as a researcher in a Pharmaceutical/biotech setting with hands-on experience in analytical instrumentation (e.g. HPLC, MS, etc.)
Experience in high-throughput lab operations such as array purification, liquid handling instruments, data interpretation, workflow management and forecasting
Technical knowledge in the field of separation sciences and SFC
Knowledge of the MassLynx software package and / or ChemStation
Strong organizational and troubleshooting skills with the ability to independently resolve issues
Excellent interpersonal skills and the ability to communicate with individuals in multiple functional areas
Ability to work in a fast-paced team environment