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Additional Sciences Resume Samples
Associate Scientist Resume Samples
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0-5 years of experience
Performed Size Exclusion and Reverse Phase HPLC analysis using Waters HPLC and HP 1100 on drug substances.
- Performed stability testing on pharmaceutical drug compounds.
- Assist in method validation and method development procedures.
- Used Millennium, ChemStation and Empower software packages extensively.
- Thoroughly trained on Microsoft office suite including Word, Excel, and Power Point. Summarized, organized and presented data at project and departmental meetings. Prepared internal reports, poster presentations and scientific papers.
- Thoroughly trained on GLP, GMP skills and worked in a regulated environment.
6-10 years of experience
Used Soxhlet column to confirm amount of corn oil yielded by ground corn feed materials, providing accurate yield information required for later in the process.
- Performed safety reviews and monthly inspections of other colleague's labs as safety management subject matter expert, identifying areas that needed to be updated and improved.
- Mentored new staff on safety and lab techniques, resulting in no injuries or incidents, increased lab efficiencies, and fewer mistakes, such as running multiple drying tests in parallel and making sure chillers can breathe so as not to overheat.
- Developed and improved process of recovering and purifying inclusion bodies (fermentation product), using centrifugation, pasteurization, homogenization, pH adjustment, and page gel analysis.
- Tested and proved equipment in the process, including Whisperfuge stacked disc centrifuge, GEA homogenizers and Microthermic's HTST sterilizer / pasteurizer, managed repair of unique equipment, enabling testing to continue with minimal downtime.
- Ensured safety management by enforcing hazards assessment management with every change or addition of equipment, and creating procedures to minimize any hazards not engineered around.
0-5 years of experience
Perform routine analysis of starting materials, intermediate and finished products for a pharmaceutical cGMP R&D operation and conduct laboratory activities required for the development and validation of analytical and test methods. Support the manufacture of MDI/DPI/Nasal drug product.
- Analyzed pharmaceutical products through the use of HPLC, UPLC and GC systems.
- Reviewed and recorded analytical data and reported test results in compliance with regulatory requirements.
- Performed sample preparation and testing in accordance with company and FDA regulatory procedures.
10+ years of experience
- Performed sample preparation prior to analysis, and minor troubleshooting in association with method development, and routine analysis of samples in a variety of biological matrices where the resultant data was intended for Pharmacokineticists and subsequent submission to regulatory authorities. Experienced in a variety of sample preparation techniques and extraction methods such as LLE, SLE and SPE. Independently prepared extraction reagents and mobile phase solutions for analyses on LC/MS and H/UPLC equipment.
- Performed and trained new scientists in dissection of biological ocular tissues (human, monkey and rabbit) prior to solid phase extraction. Successfully assisted senior scientist investigating different sample preparation methods in lab automation (Tomtec) which resulted in 50% improvement of lab efficiency and metrics. Extracted over 10,000+ ocular samples with minimal rework and investigation over my 13+ years.
- Worked in cross functional teams by collaborating with Toxicology and Microbiology personnel to collect blood samples for bioanalysis on LC/MS and H/UPLC equipment. Collaborated with various senior scientists in Drug Metabolism and Pharmacokinetics (DMPK), Toxicology and Microbiology on GLP and non-GLP ideation projects, broadened my career development. Presented project and work safety updates to peers and senior scientists via power point when needed.
- Assisted in the initial implementation of Watson, Laboratory Information Management Systems (LIMS). Assisted routinely with logging sample receipt and shipment using Watson (LIMS). Maintained timely review and verification of laboratory notebooks and technical reports in compliance with appropriate internal SOP and regulatory requirements.
- Performed routine laboratory activities that included monthly cleaning, equipment calibration and maintenance, compliance supporting activities, and the ordering and stocking of supplies.
- Proficient in the following laboratory software, Watson for sample management, PhaLIMS for weight record of ocular tissues and Quadra 4 SPE for robotic solid phase extraction.
0-5 years of experience
- Developed and optimized fermentations from lab scale to production scale of 30,000L
- Increased yield by doubling fermentation productivity
- Formulated the final product for the successful open water demonstration with >80%
0-5 years of experience
- Tested stability & release samples of drug substance and drug product using HPLC methods including SEC, IEC, HIC, and reverse phase HPLC. Performed protein concentration determination, pH, appearance and osmolality.
- Authored assay control qualification reports, SOP revisions, laboratory exceptions and deviations.
- Supported in-house testing for a small molecule program and sample submissions to a contract laboratory for moisture analysis.
0-5 years of experience
- Performed routine testing using a variety of analytical techniques.
- Supported method development and validation for multiple projects and dosage forms.
- Perform feasibility experiments and compiled data for project review meeting.
- Prepared data tables and authored validation sections for regulatory filings.
- Initialized in-house stability studies.
- Participated in cross-functional analytical working group meetings.
0-5 years of experience
- Developed analytical methods for the analysis of dosing formulations from Toxicology studies using HPLC, GC, UV-Vis, and IR.
- Developed formulation procedures for new drugs under development for use in small mammal Toxicology studies. Formulations intended for administration by I.V., gavage or dosed feed routes of administration.
- Troubleshooting and maintenance of analytical equipment.
- Authored SOPs and analytical reports.
- Trained new staff members and scheduled daily laboratory activities.
- Conducted bioanalysis of plasma samples collected from Mammalian Toxicology studies.
0-5 years of experience
- Conducted analytical testing product in research and development phase by HPLC/UPLC using empower.
- Performed stability testing on completed products, such as Dose Content Uniformity (DCU) and Aerodynamic Particle Size Distribution (APSD) by Next Generation Impactor (NGI) for final approval into consumer market.
- Responsible for preparing solutions such as buffers, diluents and standards.
- Prepared and maintained accurate records in lab notebook for all testing.
- Conducted lab work in accordance with Good manufacturing practices (GMP), SOPs guidelines and policies.
- Reviewed and approved analytical data using Scientific Data Management System (Genesis) and Copley Data Analysis Software.
- Utilize TrackWise investigations, to carefully document out-of-trend and out-of-specification results
0-5 years of experience
- Optimized simulations in Matlab to assist senior scientists in research efforts for Underwater Acoustics
- Evaluated and summarized data from simulations mined in Matlab for research proposals
- Provided solutions to legacy hardware through software emulation in Linux
- Developed office archiving system to localized all company wide resources in a convenient wiki database for ease of access
- Convinced greater Raytheon to preserve company Tuition Assistance Program benefits through a special Six Sigma research project to improve employee retention rates.
0-5 years of experience
- Expedites product development to meet client deadlines in a rapidly changing pharmaceutical industry
- Increased TOC method development by 200% in 9 months
- Optimized extensive data analysis and transcription review to reduce company's fixed costs
- Improved communication across departments to increase method efficiency
- Increased efficiency by implementing 5S and Lean Six Sigma concepts in the GMP laboratory
- Improved GMP Laboratory documentation and technical reports to exceed international audits standards
0-5 years of experience
- Performed Solubility studies with HPLC or UPLC analysis
- Drafted methods and conducted method transfers for particle size analysis by Malvern Mastersizer or microscopy.
- Contributed to the lab research and writing of 3 AAPS scientific posters and 1 Respiratory Drug Delivery Conference scientific poster representing DPT (listed below)
- Attended meetings with customers, vendors, and training sessions
- Drafted training SOP documents and conducted training sessions with Quality lab analysts for microscopy
- Maintained neat and updated R&D laboratory notebooks containing my work.
- Performed other duties such as calibrations, safety eyewash checks, supply orders, and maintained an organized and clean workspace.
0-5 years of experience
- Responsible for process development in relation to oligonucleotide delivery systems.
- Solely responsible for inventing and scaling up process that consistently achieved batch to batch reproducibility from 10ml to 200 L
- Reviewed formulation requests with biology and analytical groups to ensure deliverables met the requirements for specific study designs.
- Created work instructions and batch records, as needed, for all processes and methods utilized in manufacturing campaigns, including formulation, isolation, purification and lyophilization of drug product
0-5 years of experience
- On-the-floor project manager of a cross-functional team with a primary focus of meeting companywide objectives for the implementation of novel single use technology.
- Contributed to the development of processes for new research product candidates through lab work, authoring of procedures, implementation of new equipment, investigations into results, and led improvement initiatives.
- Manages upstream manufacturing daily activities (scheduling) within the area, delegate responsibilities to the team, trained new hires, coordinated calibrations/preventative maintenance for new and existing equipment, composed near miss/safety incident reports, performed investigations and led safety initiatives.
- Highly visible position on the SUB project team with elevated level of accountability.
- Executes and oversees a wide range of experiments / production activities independently based on scientific protocols and procedures.
- Lead of the New Employee Orientation program from 2013-2016 for Upper Merion Biopharm Research and Development sites.
- White Belt Certified.
- Lean Six Sigma Training.
0-5 years of experience
- Planned laboratory design, installation of equipment, and developed biosafety protocols and procedures for new microbiology research group in Tarrytown.
- Established technical competence related to antimicrobial testing and microbiology work in Tarrytown.
- Led microbiological work streams for multiple projects in collaboration with a global research team.
0-5 years of experience
Perform a wide range of analyses, primarily but not limited to the molecular and cell biology test areas of bio-pharmaceutical services. Tests include a variety of ELISAs, cell based and qPCR bio-assays
- Review and evaluate raw data for acceptability to each clients' specifications and requests all while adhering to GMP/GLP regulations and FDA policies
- Perform qualification and feasibility assays for incoming projects in the research and development group
- Work closely with clients during investigational testing in order to determine root causes of outliers and help to find solutions to discrepancies observed during the course of a study
0-5 years of experience
- Perform extractable and leachables analysis, characterizations with GC-MS, FID and HPLC on Finished Product and Stability samples through various extraction techniques including ASE extractions, in a cGMP/GLP environment.
- Conducted Method Validations on both in-house and customer methods
- Maintained accurate files and records
- Evaluated analytical test problems, analyze data and draw accurate conclusions
- Effectively performed duties with accuracy and competency
0-5 years of experience
- Doubled the output of high purity (≥ 99.999%) crystal production process within the first year of employment.
- Initiate troubleshooting process on products that consistently experience non-conformance issues. Follow up on insights gained by writing/editing new standard procedures for the processes in question.
- Developing and writing an improved Manufacturing Procedure for the largest process on-site, including a new starting material that helped relieve safety concerns while also remaining within quality guidelines for the final product.
- Performing manufacturing tasks in accordance with controlled documentation to ensure safety, reproducible quality, and provide traceability of process deviations.
0-5 years of experience
- Expanded my responsibilities in the pharmacokinetic evaluation of biotherapeutics (see Wyeth position below) to include more experimental study design, SOP generation, and data reporting for regulatory submissions and internal documentation
- Took the lead in organizing the different people and organizations (veterinarians, animal coordinator, radiation safety, and the researchers requesting the study) in planning for each radioactive in vivo study
- Oversaw the introduction of new technology platforms, sample analysis methods, and data collection and databasing approaches to the laboratory
- Organized the long term cold storage and cataloging of biological samples
- Represented the group as Laboratory Safety Representative to the company's EHS department
0-5 years of experience
Responsible for accurate routine chemical and physical testing in full compliance with company SOP's as well as cGMP and GLP requirements.
- Experienced in the use of Agilent, Waters component and Waters Alliance high pressure liquid chromatograph (HPLC) instrumentation and Empower software.
- Performs reviews of laboratory documentation to ensure error free reports.
- Performs required tests on routine and non-routine samples in a timely manor to support Quality Control, Stability and Product development chemistry groups.
- Consistently meets assigned monthly stability testing goals.
- Experienced in the use of Karl Fischer coulometers for water determination.
6-10 years of experience
Characterizing 20L Applikon and 6L Sartorius glass bioreactors for mixing and oxygen mass transfer ensuring transient and stable process scalability to 250L Hyclone SUB
- Coordinating production of over 2000L of deliverables for all external collaborations and internal projects using Sartorius Cultibags, GE WAVE bags, and 250L Hyclone SUB
- Increasing titer yields for stable and transient cell culture lines at least two fold by evaluating media formulations and feeding strategies
- Determining optimal bioreactor parameters and optimal fed batch conditions using DOE
- Transferring processes to outside partners under collaboration agreements
- Presenting detailed results during project and company meetings
- Writing technical reports detailing outcome of experiments and scientific findings
0-5 years of experience
- Independently lead, plan, and execute formulation & process development activities in support of biologics and small molecule candidates.
- Design DOEs, formulation screening studies, stability studies, and biophysical characterization for early and late stage molecules.
- Subject matter expert in lyophilized formulation development, stability studies, process compatibility & development studies, mixing and filter flush studies.
- Develop small scale studies to give feasible solutions to large scale GMP process issues.
- Interact and collaborate with clients to interpret data, take scientific decisions and decide future direction of projects.
- Work in cross-functional teams (Tech Services, Engineering, Analytical, QC, etc.) to successfully drive multiple client projects within set budget and timeline.
- Learn and implement new technologies in a short span to execute client deliverables and expand the department capabilities.
0-5 years of experience
- Supervised and coached entry and intermediate levels employees and interns.
- Managed method development and qualification for regulatory submission, including IgGs, vaccines, biospecific molecules, and process related impurities.
- Interfaced with relevant functional groups to coordinate the timely execution of analytical demands in CMC activities and methods synchronization.
- Coordinated assay training, tech transfer and outsourcing.
- Actively engaged in the evaluation of innovative technology development to characterize critical quality attributes of diverse IgG and biomolecule drug products.
- Supervised method development and qualification of formulation excipients and adjuvants analysis.
- Effectively delegated analytical method development of quantitation of potential trace residuals in protein preparations, such as Dextran Sulfate, Triton X-100, Imidazole, methotrexate (MTX), L-Methionine Sulfoximine (MSX), ethylenediaminetetraacetic acid (EDTA).
- Developed GC and HPLC methods for the determination of water-soluble vitamins in cell culture media, feed and yeastolate.
- Sponsored in the yellow belt projects and identified candidate, and contributed to the planning and execution of new laboratory processes.
- Presented proposal, data and method development findings at department/project meetings and external conferences.
0-5 years of experience
- Produced large scale plasmid preps for therapeutic antibody research use.
- Performed plasmid quality control assays and endotoxin removal.
- Did ligation-independent subcloning and restriction enzyme subcloning.
6-10 years of experience
- Carried out DNA sequencing services: organization of samples, preparation of reaction log, setting up custom reactions, and performing alternative protocols
- Prepared primer walking sequencing reactions and fragment analysis
- Managed quality control and dilution of laboratory primers and reagents
- Assigned to process and handle GLP and CLIA samples
- Backup Team Leader to oversee that proper lab procedures and SOPs are followed to keep a safe and productive environment
- Conducted PCR, EXOSAP, and large scale sequencing projects on PerkinElmer JANUS
- Cross-trained to help other departments such as Molecular Biology and Technical Support
- Maintained ABI sequencers, automatic dispensers, and other lab equipments
0-5 years of experience
- Utilized PMP automated system for use in clinical testing.
- Performed bacterial incubation and growth with both agar plates and media suspension.
- Frequent use of pipettes (single channel and multichannel) and serological pipettes for various tasks.
0-5 years of experience
- Perform chemical and physical testing for in process, finish product and stability transdermal samples.
- Use and maintenance of HPLC, UV and physical testing equipments.
- Conducts QC lab investigations using Trackwise.
- Perform documentation and data process for acquired testing results.
- Use acquisition data software like Empower and Lims.
- Performs trainings and provide technical support to analysts as required.
0-5 years of experience
- Performed immunogenicity and ELISA assays both individually and as part of a larger team in support of vaccine sciences department while following Good Laboratory Practices and Good Manufacturing Practices guidelines. Experience using automation to complete assays.
- Responsible for maintenance and troubleshooting of laboratory equipment, including plate readers, plate washers, and automation used for performance of assays
- Handle biohazardous materials while maintaining personal safety and lab cleanliness, including 5S system to maintain laboratory efficiency.
0-5 years of experience
- Performed analytical testing on dry powder inhalers (DPI) in development phase by HPLC/UPLC using empower.
- Experienced in testing Dose Content Uniformity (DCU) and Aerodynamic Particle Size Distribution (APSD) by Next Generation Impactor (NGI).
- Prepared solutions following standard laboratory formulas and procedures.
- Calibrated and maintained laboratory equipment.
- Followed GMP guidelines, company SOP’s and established test method.
- Experienced in reviewing and approving analytical data using Scientific Data Management System (NuGenesis).
- Carried out analytical water content testing on DPI by Karl Fisher Coulometer system.
- Analyzed Foreign Particles on DPI utilizing digital microscope.
- DPI reflectance testing by UV-Vis.
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