Summary : Over 13 years hands-on experience in Pharmaceutical laboratories working in compliance with GMP, EU GMP, DEA, FDA, USP, ICH and ISO guidelines and regulations with a thorough knowledge of finished product, in-process, stability, and raw material testing. Gained $400K/year in savings and improved laboratory efficiency through lean manufacturing. Reduced complaints by 20% and achieved customer lot acceptance of 99%.
Skills : Microsoft Office, Quality Management System.
- Team Lead for high priority projects including new product launches.
- Schedule and supervise daily shift work of chemists and assign tasks.
- Communicate with lab technicians, chemists and laboratory managers to prioritize and update project status.
- Assist in preparing, review and revision of departmental SOPs, methods and worksheets.
- Collaborate cross-functionally to improve efficiency, solve problems, improve quality and provide new product support.
- Give guidance in the conduction of investigations and deviations as required.
- Team member accelerated quality program, over saw the laboratory optimization work stream.
Master Of Science
Associate Scientist Resume
Summary : Twenty-five years of experience in both scientific vendor and pharmaceutical industries. Proven track record of cell culture methodologies covering a diverse array of cell lines including yet not limited to: human embryonic stem cells (ESC), induced pluripotent stem (iPS) cells, mouse ESC and human adult stem cells. Well versed in strategic and creative concepts to optimize cell culture and differentiation protocols.
Skills : Scripting, Email Marketing, Blender, Unity, Level Design, Game Design.
- Weekly in vitro experimentation in microbiology, entomology, molecular biology, or phylogenetics.
- Scripting in programming languages (python, R) for data transformation, statistical analysis and data visualization.
- Weekly lab safety maintenance and monitoring.
- Monthly inventory, ordering and Material Safety Data Sheet maintenance.
- Management of simultaneous projects and development of Standard Operating Procedures.
- Collaboration with intra- and extramural researchers.
- Experimental data collection and database administration.
- Data analysis, including hypothesis testing and power analysis.
MA In Game Design
Computer Scientist Resume
Objective : Highly motivated, creative and versatile immunologist and molecular biologist Extensive experience in human and murine cellular and immunological assays.
Skills : Molecular Biology.
- Genalysis Platform Advancing and developing of molecular diagnostics Next Generation Sequencing and amplification system.
- Currently working as a consultant from US on integration of the assay development and primer designing.
- Project manager of key projects for the product developments.
- Design, verification and validation of assay for blood stream infection (BSI) panel along with antibiotic resistant gene.
- Developing the assays with standard molecular biology methods and integrating to the CMOS sensor platform.
- Transferring and tuning the chemistry of the assay to the requirement level for pH detector CMOS sensor.
- Working with the team and management for design, project planning, milestones, risk analysis.
- Coordination plans and experiments with other team such as cartridge design, PCR on chip, bead amplification and sequencing.
Research Scientist Resume
Summary : An experienced analytical chemist with over 10 years USP experience. Solid hands-on experience working and collaborating with drug companies, FDA, USP and EP, and testing laboratories. Well versed with ICH guidelines and FDA guidances as relate to cGMP/ GLPs, pharmaceutical documentation, method development and validation. Good knowledge of compendial standards related to pharmaceutical product/ industry and of regulatory requirements and (FDA and ICH) industry guidances.
Skills : Project Management, Management, Process Development, Manufacturing.
- Managed a portfolio of diversified reference standards (RS) for testing drug substances, products, impurities, and excipients.
- Worked closely with cross-functional teams and provided technical lead/ support as needed to ensure suitability and availability of all assigned RSs.
- Developed technical documents such as specifications for procurement, testing, and packaging, protocols for collaborative lab evaluation and product investigation, analytical methods, and procedures, stability studies, product application document packages, QC tests and others as needed.
- Provided technical support for collaborators and prepared associated documents for customer synthesis, outsourced formulation and package projects.
- Reviewed technical documents, analytical data and reports generated by peer chemists and scientists.
- Reviewed, complied, and interpreted lab data/ reports.
- Prepared and presented product supporting documents to review teams/ expert committees for review and approval; responded to approval related comments.
- Reviewed reference standard related monograph (USP-NF and EP) tests and instrumentation.
Data Scientist Intern Resume
Summary : Over 15 years experience as a medicinal chemist in the pharmaceutical industry as well as being a co-inventor on six patents.
Skills : Scripting, Email Marketing, Blender, Unity, Level Design, Game Design.
- Responsible for preparing GLP study reports, eCTDs and CTDs for submission to FDA.
- Wrote and provided quality control of reproductive and developmental toxicity reports.
- Drafted and assembled reports including data tables and appendices generated from raw data.
- Graphs and table generation using Excel spreadsheets or MS Word documents.
- Analysis of data sets and preparation of documents used in the Common Technical Document.
- Working knowledge of electronic assembly and submission of safety studies (e.g.
- Served as coordinator for Standard Operating Procedures (SOP) for the Reproductive and Developmental Toxicology section involved in writing and editing, new and revising SOPs.
Process Scientist II Resume
Summary : Highly motivated Scientist with drug discovery Research and Development and manufacturing experience in the pharmaceutical industry. Proficient with data analysis and stigmatization. Proven ability to work both independently and part of a multidisciplinary team.
Skills : Microsoft Office, Leadership.
- Predicted exposure for projecting tissue dosimetry in human mass balance studies in tissue distribution utilizing radiolabeled compounds.
- Submitted reports and conducted Metabolism, Pharmacokinetic and Pharmacodynamics experiments.
- Evaluated and analyzed data from in vitro and in vivo discovery experiments.
- Collaborated on several cross-functional teams in projects encompassing the Neuroscience and Antibacterial therapeutic areas.
- Selected Contributions: Implemented program direction decisions resulting in the acceleration of the Alpha-6 program.
- Recipient of an individual performance award for developing an extensive data package including cross-species metabolism and oral bioavailability for each of the three lead chemical compound series as part of a Pfizer project team seeking the full understanding of risks and benefits of three lead compound series.
- Determined whole-body tissue distribution in rats with radiochemicals from animal dosing, whole-body cryosectioning utilizing a cryomacrocut, autoradioluminography technology, computer imaging tissue radioactivity and analyzing pharmacokinetic data.
Adjunct Assistant Scientist Resume
Summary : Experience with overall planning, development, implementation, organization and execution of scientific functions. Experience providing leadership, direction, and problem resolution. Experience with providing strategic scientific plans, quality control and process improvement. Very adept with research protocols and procedures. Self-starter and team player that is very diplomatic and innovative, with excellent negotiation and interpersonal skills.
Skills : NMR, IR, MS, GC, LC/MS, TLC, flash chromatography,.
- Developed analytical testing methods for ANDA Solid Oral Dosage Form Pharmaceuticals.
- Assembled various documents for ANDA applications.
- Assisted product development in bringing generic drug candidates from conception through ANDA submission.
- Set drug substance and drug product specification in accordance with FDA and ICH guidelines.
- Evaluated API vendors, drug substance characterization, set drug product stability specifications, released raw material, released drug product for clinical trials, reviewed and approved process validations, method validations.
- Served as analytical representative at product team meetings, responded to FDA correspondence letters.
- Interacted with Regulatory Affairs for submission of product, change control documents, division of bioequivalence documents.
- Trained and mentored other scientists and chemists Actively contributed to method transfers to other sites.
Environmental Scientist Resume
Summary : Development and optimization of constructs used for tissue engineering, drug delivery, and regenerative medicine, as well as the body's response to such devices. My research has focused on relating material structure and composition to mechanical and biological functionality.
Skills : Research laboratory leadership Experimental design.
- Established and maintained ocular cell lines to develop and validate screening assays in order to assess efficacy, potency, and safety of drugs or compounds for a go/ no go decision in the time frame established.
- Research Projects Highlights: Actively participated on a team to screen a drug library and made an on time no go decision.
- Designed protocols, performed experiment, analyzed data, and wrote study reports on a regular basis.
- Able to complete experiments for beginning to end.
- Responsible for analysis of data, interpretation, and presentation for results during department meetings.
- Contributed to the development of a selective glucocorticoid receptor agonist (SEGRA) for the non-systemic treatment of inflammatory eye disorders that was licensed.
- Developed an ELISA to detect and quantify myocillin levels in ocular cell supernatant.
BS In Biotechnology
R&D Scientist Resume
Objective : 8-year industrial and academic oncology drug research and discovery experience Success of leading projects from target validation into lead identification stage Expertise in small molecule entities, assay development, compound screening and in vivo tumor models Collaborating with internal Technical Support team and managing external CRO to deliver high quality data Record of publications in mainstream scientific journals.
Skills : GMP, cGLP, pH Meter, IR Spectroscopy, UV/Vis Spectroscopy,.
- Project leader for pharmaceutical multidisciplinary research, biochemistry and analytical projects (including large and small molecules) in cGMP contract research laboratory with wide range of goals.
- Primary focus on protein or polymer characterization, aggregation studies of biomolecules in solution.
- Managing number of projects which include client communications, understanding project requirements, communicating expectations to scientists, planning work, delegating and prioritizing to ensure projects are completed in a timely manner, short term and long term goals.
- Hands on experimental bench work, performing analytical techniques, and instrument operations, data and results interpretations.
- Recognize and resolve simple and complex technical issues, which arise during analyses and method development, evaluating alternatives and initiating corrective actions.
- Participating in the scientific and technical discussions with internal and external clients to provide guidance in the technical areas and a high level of service.
- Write and review scientific reports, data summaries, instrument operating procedures (IOP), and methods (MTD).
- Participate and lead quality investigations in compliance with internal procedural requirements and regulatory requirements, working knowledge of cGMP regulations and practices.
M.S. In UTC
Senior Scientist Resume
Summary : Innovative R&D scientist with a strong background in consumer packaged goods. I have significant experience and interest in product development, formulation & stability, designing & executing research programs and optimizing product design/performance. I'm looking for opportunities to manage technical projects and/or people.
Skills : Nucleic acid sample preparation, quantification, PCR, qPCR, Emulsion PCR, library prep for Illumina, 454 and Ion Torrent sequencing platforms, Next Generation sequencing using Ion Torrent, purification, shelf life studies, process development, COGs reduction.
- Provided support during study design, start up, conduct and close-out of clinical trials.
- Defined and designed e(CRFs) and data management plans.
- Accounted for and cleaned data prior to data base lock and statistical analysis.
- Collaborated with external business partners, investigating and evaluating new, industry changing technology for cough counting research.
- Improved time-consuming data processing procedure leading to 10x reduction in processing time, increasing capacity and shortening overall study timelines.
- Co-authored, implemented and executed against several clinical protocols for multiple product trials (drugs and devices), demonstrating product efficacy or superiority.
- Designed and implemented clinical data management plans, and trained clinical sites, ensuring rigorous data collection and documentation.
Interpretations Scientist Resume
Headline : Over seven years of professional experience in the field of life sciences with strong experimental and analytical skills. Hardworking, dedicated and energetic professional with an ability to work independently as well as in a team environment. Excellent communication and presentation skills, with dedication to meet and exceed project goals.
Skills : Microsoft Office, Chemdraw, Chemdraw, Minitab, Organizational Skills, Chemical Anaysis, Chemical Anaysis, Leadership Development.
- Conceptualized, synthesized and conducted performance assessments of lubricant base oils/additives or formulations meeting critical customer objectives and/or address urgent market trends.
- Managed timelines and deliverables with direct impact on project stage-gate progression.
- Led multiple external customer and research partner relationships ensuring project deliverables and timelines were met.
- Coordinated external resources to hasten product development timelines.
- Identified and coordinated testing labs, defined market studies and enlisted industry expert consultants.
- Optimized an addition reaction of maleic anhydride and unsaturated methyl esters.
- Utilized specialty esters for reactive coalescent properties in waterborne paints and coatings applications.
- Incorporated novel polyester polyols for TPUs and PUDs with added strength and tear resistance.
Summary : To pursue a career as chemist utilizing education, extensive instrumentation experience and work experience.
Skills : Microsoft Office.
- Analyze Ointment, Topical Gel, Patches, oral Suspension, inhalation Solution and stability samples.
- Perform Waters HPLC with Empower Software for Analysis of Ointment, Topical Gel and Patches and cleaning verification.
- Conducted routine and non-routine analysis of raw materials, in progress and finished Product, Complain samples & special projects on analytical problems on a strict timeline.
- Perform ICP-OES for cleaning verification and Metal content.
- Strong working knowledge of HPLC, ICP-OES, UV-VIS Spectrophotometer, FTIR Spectroscopy and Karl-Fisher.
- Experience with Dissolution, Disintegration, Potentiometer, Polari-meter and Microscopy.
- Perform routine maintenance and trouble shooting of HPLC, ICP-OES and Karl -Fisher.
- Maintained proper documentation of laboratory data and reported results as per established SOP.
Master Of Science