Top Principal Scientist Skills

Below we've compiled a list of the most important skills for a Principal Scientist. We ranked the top skills based on the percentage of Principal Scientist resumes they appeared on. For example, 8.9% of Principal Scientist resumes contained Analytical Methods as a skill. Let's find out what skills a Principal Scientist actually needs in order to be successful in the workplace.

The six most common skills found on Principal Scientist resumes in 2020. Read below to see the full list.

1. Analytical Methods

high Demand
Here's how Analytical Methods is used in Principal Scientist jobs:
  • Evaluated the adequacy of analytical methods and reports used for new formulation synthesis, characterization, and stability testing.
  • Team lead responsible for identifying ICH deficiencies in analytical methods and validation documents supporting marketed products tested by GPSG.
  • Trained individuals on analytical methods and instrumentation; troubleshot instruments where needed.
  • Evaluated and validated pharmaceutical analytical methods for use in quality control laboratory.
  • Developed, validated and transferred small molecule/raw material analytical methods.
  • Assist regulatory filings on changed/re-validated analytical methods for MPL.
  • Develop analytical methods for research products.
  • Develop and validate analytical methods.
  • Characterize products with their mechanical and chemical properties, develop analytical methods and transfer them to QC department.
  • Review of Analytical Methods & Test Procedures to comply and in-line with the current guidelines and Monographs.
  • Managed a group of scientist and provided hands on training on various analytical methods.
  • Developed TLC, GC and HPLC analytical methods to determine assay and impurities.
  • Updated validation of analytical methods as needed in compliance with JP.
  • Transferred the analytical methods to contract laboratories and other GSK facilities.
  • Transfer analytical methods from R&D site to GMS site.
  • Determined best analytical methods for two new projects.
  • Provided technical leadership in analytical research and development to enable the development, optimization and validation of analytical methods.
  • Design and develop bio-analytical methods for virus detection and titration.
  • Developed and optimized analytical methods for purification of the lantibiotic MU1140 directly from fermentation broths using reverse phase chromatography.
  • Developed and validated analytical methods to control genotoxic impurities with LC-MS, headspace GC and HPLC.

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2. Regulatory Documents

high Demand
Here's how Regulatory Documents is used in Principal Scientist jobs:
  • Authored and reviewed pharmacology section of regulatory documents for US and global regulatory submissions.
  • Write technical reports, participate in preparing Regulatory Documents.
  • Write regulatory documents for IND submission.
  • Authored and reviewed non-clinical summary sections of regulatory documents associated with levomilnacipran (e.g.
  • Authored Regulatory Documents directly supporting Investigative New Drugs (INDs) and New Drug Applications (NDAs).
  • Prepared data and contributed in writing publications and regulatory documents.

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3. Drug Discovery

high Demand
Here's how Drug Discovery is used in Principal Scientist jobs:
  • Provided solution and LC-NMR support to Drug Discovery and Chemical Development to obtain structural information on organic synthesis intermediates/products.
  • Utilized pilot projects to optimize reagent production for basic internal drug discovery and reagent support for clinical development.
  • Implement novel assay technologies and process improvements to facilitate drug discovery success.
  • Re-defined target discovery process as part of site-wide re-design of drug discovery.
  • Co-developed novel cell-based drug discovery platform for human and viral targets.
  • Developed/validated animal models for five drug discovery groups.
  • Developed expertise in fragment-based drug discovery.
  • Directed the implementation of a compound plating and storage system to support our internal drug discovery efforts.
  • Identified troubled protein reagents, proposing new constructs with correct biochemical properties for drug discovery and development.
  • Lead and conduct drug discovery projects for liver cancer, obesity and diabetes treatments.
  • Developed strategies for modeling and predicting DDI in Drug Discovery and Early Development.
  • Led and trained a small group of scientists in the drug discovery department.
  • Led projects for small molecule drug discovery targeting kidney fibrosis and eye diseases.
  • Propose and implement ADME/PK strategies for multiple drug discovery project teams.
  • Promoted to chemistry project team leader for a drug discovery project.
  • Head of the Physical biochemistry group in Drug Discovery.
  • Project leader on 9 chemical-based or protein-based drug discovery programs that successfully advanced into lead optimization and pre-clinical development.
  • Applied computational biology techniques to advance drug discovery projects in neuroscience and cardiovascular and metabolic disease therapeutic areas.
  • Managed project to establish various cell-based and biochemical assays for anti-angiogenesis and small molecule anti-cancer drug discovery were.
  • Focused on drug discovery and development of antibody-drug conjugates and antibody-peptide conjugates.

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4. R

high Demand
Here's how R is used in Principal Scientist jobs:
  • Designed and programmed a demonstration version displaying the total functionality of a major network optimization tool under development by GRCI.
  • Provided guidance in the area of cardiovascular safety pharmacology and maintained state-of-the-art laboratory for conducting telemetry study in animals.
  • Served as individual contributor as well as provided technical support for research and manufacturing activities of global organization.
  • Developed internal and external scientific/technical training, and technical policy within seven offices throughout the southeast United States.
  • Contributed to development of new gene editing products by processing and visualization of Next Generation Sequencing data.
  • Assure that the technical information appropriately supports the chemistry, manufacturing and controls requirements for Applications.
  • Advise project reps, safety assessment colleagues and clinical pharmacology to design appropriate drug-drug interaction strategies.
  • Conducted an in-depth review of open-source, peer-reviewed, academic and professional literature in electoral geography.
  • Collaborated with lead optimization teams as independent medicinal chemists, with a specialty in automation.
  • Design and develop automatic defects inspection software able to discriminate between tire defects.
  • Calculated high fidelity ballistic trajectory and signature profiles to analyze sensor performance.
  • Company representative for research presentations at national meetings and publication of research work
  • Generated and reviewed scientific data and reports and ensured consistency and accuracy.
  • Function as Facility Manager for Efficacy (Functionality/Pharmacology) and Toxicology Groups.
  • Designed imaging optics for iris based registration of measurement with treatment.
  • Collaborated and advised on other drug discovery programs within the company.
  • Managed hit-to-lead projects, employing traditional or parallel synthesis where appropriate.
  • Develop strategies for dissemination of information to customers and professional groups.
  • Headed international teams composed of scientists, engineers and marketing personnel.
  • Directed experimentation to solve manufacturing problems or to develop new products.

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5. Medicinal Chemistry

high Demand
Here's how Medicinal Chemistry is used in Principal Scientist jobs:
  • Investigated Structure Property Relationship (SPR) and collaborated with Medicinal Chemistry group and designed compounds with improved properties.
  • Collaborated internally with medicinal chemistry department scientists to evaluate several compounds with novel chemistry for several projects.
  • Planned, organized and conducted all in-house exploratory medicinal chemistry research.
  • Contract research in medicinal chemistry for national and international clients.
  • Provided technical leadership for several lead optimization medicinal chemistry projects.
  • Applied these models both to compounds designed personally and ideas from medicinal chemistry team members.
  • Led project teams in medicinal chemistry route selection and preparation of small analog sets.
  • Collaborated with a Japanese partner and CRO in a shared medicinal chemistry program.
  • Provided the company with diverse medicinal chemistry services as in previous employments.
  • Presented the results at the Global Medicinal Chemistry and Discovery Technologies Meeting.
  • Utilized medicinal chemistry skills to advance four projects.
  • Manage contract manufacturers for Medicinal Chemistry Optimization, Scale-up Synthesis, Pharmacokinetics and Stability.

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6. Protein

high Demand
Here's how Protein is used in Principal Scientist jobs:
  • Managed overall responsibility to identify, isolate, conjugate and purify key antibodies and proteins.
  • Led an exploratory research program investigating a novel protein up through target validation.
  • Investigate manufacturing process to obtain proteins from alfalfa.
  • Team leader of a protein-protein inhibitor project (CD80-CD28) for MS. Major contributor to site expansion in Cambridge.
  • Research: Conducted crystallography studies on purified proteins on a joint project with NASA and University of Alabama.
  • Led affinity project on acoustic selection of proteins and mammalian cells for CAR T-cells manufacturing.
  • Used specialty milk proteins to successfully prevent hardening and browning of nutrition bars over shelf-life.
  • Scale up successful process for alfalfa proteins to pilot scale to explore market opportunities.
  • Led a team to develop Java modules to display protein sequences and structures.
  • Lead all aspects of computational protein engineering on-site (among 130 scientists).
  • Developed a database for query of three dimensional protein structures and properties.
  • Developed a novel process for production of algal protein isolate.
  • Selected, acquired and ensured quality control of antigens Lead group of scientists responsible for maintaining protein-related expertise throughout the company
  • Generated homology models for G-protein coupled receptors for use in virtual screening and selectivity predictions.
  • Supported biologics pipeline by providing expertise for fusion proteins, antibody design and development.
  • Target protein expression, refolding, purification and co-crystallization for ligand design.
  • Demonstrated trimerization of TNF-alpha target and developed modified proteins with improved stability.
  • Advised pre-clinical and clinical teams in identifying and monitoring potential protein-based markers.
  • Discovered new excipients to enhance protein solubility for DSP and formulation process.
  • Patented a random-mutagenesis method for the detection of functional protein domains.

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7. FDA

high Demand
Here's how FDA is used in Principal Scientist jobs:
  • Directed the optimization and characterization of product designs and manufacturing processes for submission to FDA.
  • Project leader for FDA Warning Letter remediation activities associated with cell banking and qualification.
  • Supported regulatory submissions including face-to-face interactions with the FDA.
  • Defended a complex customer complaint investigation during FDA audit
  • Ensured compliance with appropriate WW and FDA Regulatory requirements, as well as OCD and J&J Quality System requirements.
  • Generate data and prepare documentation for FDA 510(k) clearance application and ensure compliance with all regulatory requirements.
  • Conducted, as member of Sustainable Compliance Initiative Team, the gap analysis and remediation for the FDA consent decree.
  • Provided technical support and representation for all key submissions or meetings with governmental agencies (FDA, USDA).
  • Ensured all aerosol test methods comply with current FDA, ICH, USP, and EP regulations and guidelines.
  • Led team that generated experimental results package for successful Generally Regarded as Safe application with US FDA.
  • Collaborated with FDA scientists as part of a Pfizer/FDA CRADA to develop chemical imaging for PAT.
  • Designed and directed projects studying stability of drug substance and product to answer questions from FDA.
  • Point of contact for audit inspections by FDA and EU regulatory authorities and quality assurance/control.
  • Participate in all FDA, BSI, ISO and customer/supplier audits conducted at the laboratory.
  • Contracted and produced documents with CRO's to support IK-5 (BCM) FDA submission.
  • Managed FDA Clinical Trials, submissions, and US Launch of tumor markers.
  • Performed studies, assisted with troubleshooting, and collected data for FDA review.
  • Participated in fill finish of FDA 510(k) submission preparation.
  • Maintained current awareness of relevant FDA and other governmental rules and guidance.
  • Prepared reports for FDA submissions and participated in answering FDA queries.

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8. New Product Development

high Demand
Here's how New Product Development is used in Principal Scientist jobs:
  • Generated advanced physical models to optimize performance during new product development.
  • Assisted in the initiation of research and new product development program related to PVC additive as well as polymer coated textiles.
  • Administered technical leadership and guidance on New Product Development (NPD) projects developed both in- house and with outsourced contractors.
  • Used expertise to support new product development and marketed product troubleshooting for 4 business units.
  • Build, implemented and validated new manufacturing processes, if new product development required.
  • Led development of custom products and managed workload with new product development.
  • Identified strategic new product development targets for key brands.
  • Developed and validated new analytical test methods to support new product development or reduce the cost of quality.
  • Received New Product Development Awards, Innovator Award, Professional Society , 2009.
  • Achieved New Product Development Excellence, Technical Achievement , 2012.

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9. Cros

high Demand
Here's how Cros is used in Principal Scientist jobs:
  • Participated in enterprise-wide project for evaluation, selection, and deployment of networking infrastructure to facilitate cross platform information exchange.
  • Led cross-functional team in sustainable development efforts, including creation of meaningful metrics in support of Corporate Social Responsibility platform.
  • Identify new processing technologies to assist in food safety and spoilage issues during manufacturing across different product categories.
  • Defined and executed cross-functional program strategy; collaborated and led partner lines to engineer therapeutic molecules.
  • Project involved frequent cross-discipline meetings, development of final-product criteria, evaluation and beta-testing of software.
  • Developed protocols for assay crossover analysis & transferred two assays to the Quality control department.
  • Facilitated cross functional brainstorming sessions to generate innovative product opportunities for proof of concept evaluation.
  • Interfaced with cross-functional teams including Regulatory Affairs, Quality Compliance and Quality Assurance etc.
  • Interacted across multiple departments and with customers to ensure cohesive understanding of initiatives.
  • Collaborated with cross-functional team members to support regulatory submissions of acquired medical devices.
  • Worked with key stakeholders and cultivate cross-departmental relationship in blood glucose monitoring systems.
  • Worked with department management to drive training effectiveness and cross training activities.
  • Tailored computer validations best practices across the manufacturing and packaging functional units.
  • Matrix-managed team of scientists assigned to early discovery projects across therapeutic areas.
  • Co-developed Kraft's technical career framework and mentored junior scientists across disciplines.
  • Served in an advisory capacity within and across departments.
  • Automated high-throughput fluorescence microscopy for high-content screening.
  • Cross sector collaboration and identifying new synergies.
  • Work cross-functionally to address product performance events.
  • Participate on cross-functional development teams.

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10. Clinical Trials

high Demand
Here's how Clinical Trials is used in Principal Scientist jobs:
  • Led global human clinical trials in nutrition and activity to position Gerber as a leader in nutrition research.
  • Phase 2 clinical trials for the treatment of inflammatory diseases (rheumatoid arthritis).
  • Project has progressed to yield chemical matter that is in clinical trials.
  • Led two IND-enabling teams, one of which successfully reached clinical trials.
  • Compound currently in phase 2 human clinical trials
  • Worked under strict aseptic conditions for synthesis of clinical batches Scaled up polymer synthesis for clinical trials
  • Characterized in vitro resistance mechanisms of a DR5 antibody previously in clinical trials.
  • Provided bioanalytical support for non-clinical studies, phase 1, 2 and 3 clinical trials, as well as post-marketing support.
  • Design and coordinate drug discovery efforts from ideation to first in human clinical trials (Phase II).
  • Led four research program teams, one of which nominated a development candidate which successfully reached clinical trials.
  • Research Technician Provided research support for human clinical trials on Rheumatoid Arthritis.
  • Developed cfDNA-based NGSassays Developed molecular assays for clinical trials - Eg: Array-CGH, Pyrosequencing, NGS andNanostring gene expression assays.

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11. Drug Products

high Demand
Here's how Drug Products is used in Principal Scientist jobs:
  • Performed forced degradation, similarity, comparability and stability studies of drug substance and drug products.
  • Reviewed and Approved Specifications for the Drug Products, managed investigations/Deviations.
  • Characterize degradation products of drug products.
  • Transferred analytical technology to contract manufacturers and set up specifications for drug substance and drug products.
  • Project manager on non-clinical product development teams of 2 high-profile abuse-deterrent controlled release opioid drug products.
  • Perform and approve release testing for starting and raw materials, intermediates, APIs and final drug products manufactured in house.
  • Identify and characterize impurities and degradants in API and Drug Products with ION TRAP LC/MS.
  • Identify and quantitate trace-level of impurities in drug substances and drug products.
  • Conducted extensive hands-on analytical and preformulation characterization in support of Oncology, Virology, and Inflammation NCEs and drug products.

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12. Small Molecules

high Demand
Here's how Small Molecules is used in Principal Scientist jobs:
  • Executed the innovative ideas for small molecules, such as compounds' derivatives, analogues, and different crystalline structure.
  • Created and managed intellectual property to submit 6 patent applications for method and composition of small molecules for Oncology.
  • Initiated work on small molecules binding to RNA to enable this platform.
  • Designed 96-well assays for the determination of physicochemical and metabolic properties of small molecules and validated procedures for fee-for-service business
  • Recommended candidates, small molecules and biologics, for clinical development for several therapeutic areas
  • Provided scientific support for the extraction of small molecules from complex sample matrices for mass spectrometric analysis.
  • Designed and executed experiments to de-risk 4 projects, defining the pharmacology of small molecules and peptides that modulate.
  • Up to 500 chromatographic analysis per week were utilized (mainly small molecules analysis).

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13. API

high Demand
Here's how API is used in Principal Scientist jobs:
  • Managed capital budget, staffing, facilities development, personnel management, assay development and laboratory readiness for clinical testing.
  • Hired to establish a technology transfer methodology that is appropriate for the rapidly evolving innovations in a small company environment.
  • Managed pediatric dose development project, technology transfer project and alternate API supplier qualification project on budget and on schedule
  • Capitalized on engineering background to lead project planning for various collaborations between government, academia and industry.
  • Designed projects for microbiology lab automation, rapid raw material qualification and LIMS implementation.
  • Budget laboratory operations, inventory, sampling plans and capital expenditures.
  • Performed rapid and complete structure confirmation of reference standards.
  • Focused on small molecule anti-cancer therapies.
  • Developed technical aspects of a well-established, rapidly growing indoor air quality certification program for low emitting products (GREENGUARD).
  • Involved in the technology transfer of the API to BMS-Ireland including LTSS campaign, validation batches, and commercial production.
  • Reconstructed a failed project where the API disintegrated in solid state because of unknown reasons in a JNJ-antibiotic program.
  • Analyzed data, proposed target molecules, designed and executed synthetic methods for the rapid development of the projects.
  • Utilized careful scientific rigor to rapidly come to strategic decisions, which were used to smoothly influence cross-functional teams.
  • Support budget management, control and maintain inventories, create capital appropriation projects and purchase requisition reports and invoices.
  • Contributed to production and delivery of company's natural product plant library for consumer use for rapid drug discovery.
  • Obtained Series B funding of $8M via technical presentation of results to a board of venture capital investors.
  • Manage a small team of chemist responsible for delivering PK sample analysis in a rapid and accurate manner.
  • Assisted in the development of a Rapid Strip test for point of care to detect UTI.
  • Designed test protocols and analyzed Quality control solutions for six HIV-1/2 point of care Rapid tests.
  • Synthesized compounds for pharmaceutical and chemical industry: infrared dyes, chemical intermediates, API.

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14. IND

high Demand
Here's how IND is used in Principal Scientist jobs:
  • Performed development of new therapeutic reagents and verified their ability to bind specific target and compete with receptors by high-throughput screening.
  • Provided critical biotechnology support in identifying correct binding areas of therapeutic proteins (monoclonal antibodies) to disease targets.
  • Provided expert witness testimony in deposition and at trial regarding chemical exposures in indoor spaces resulting from product emissions.
  • Provided scientific expertise in initiating, executing and exploring therapeutic indications to treat cardiovascular, pulmonary and renal diseases.
  • Direct strategic air permit and compliance assurance programs for a variety of industrial clients with complex technical/regulatory issues.
  • Review relevant laboratory documentation (individual documents and reports) and related documentation in support of regulatory submissions.
  • Gathered and validated scientific data to recommend alternative indications; assisted in regulatory processes and submissions.
  • Transformed culture in technical communications through individual coaching, transparent communication, and strong performance management.
  • Analyzed complex data internal and external to elucidate contaminants chemical structure and find rot cause.
  • Established Welding Engineering/NDT department and metallurgical failure analysis laboratory for government and industrial applied research.
  • Provided timely Response-to-Questions to regulatory bodies (Germany and South Korea) regarding CTA/IND submission.
  • Reviewed assay results including analyzing data and authorizing release of reports to individual project teams.
  • Optimize different extraction procedures for assaying different kind of products such as Gels/Lotions/Creams/Ointments/Oils/Aerosols/Solutions.
  • Implemented and supported 96-well equilibrium dialysis method for conducting matrix binding assessments.
  • Established electrical kindling assay in mice to assess seizure sensitivity and development.
  • Facilitated joint ventures and partnerships with other industry experts and corporations.
  • Designed customized hit-finding strategies in collaboration with early discovery project teams.
  • Discovered a new therapeutic indication of MB109 in obesity control.
  • Drafted and edited non-clinical safety assessment tables for IND application.
  • Participate in reviewing industry guidance, panels and professional committees.

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15. Oncology

average Demand
Here's how Oncology is used in Principal Scientist jobs:
  • Led efforts to implement technology for functional identification of targets in Oncology, CNS disorders, and others.
  • Supervised generation of soluble EGF receptor (erb-1, HER1) for oncology program.
  • Developed a reliable green process for Phase-II/III development of an oncology asset.
  • Project leadership in Oncology and Inflammation.
  • Developed formulations, test methods and product specifications for neuroscience, infectious disease and oncology businesses.
  • Established the antibody discovery platform being utilized to discover novel therapeutic antibodies for oncology.
  • Engineered bispecifics for oncology indications and developed cell-based assays for therapeutic candidate evaluation.
  • Supported biomarker development of lead oncology candidates from late discovery through clinical development.
  • Led the discovery bioanalytical group to support Oncology, Neurology and Immunology.
  • Involved in the medicinal area of oncology, specifically new anti-oncologic agents.
  • Supported protein targets to treat metabolic, oncology, neuroscience and inflammation disease models from early discovery to late stage.
  • Led the bioanalytical and drug disposition labs in Dermatology and Oncology Received Roche Special Recognition Award for Scientific Achievement
  • Developed high through put in vitro assays to determine efficacy of synthetic taxanes utilized in oncology treatment.
  • Project Leader in a matrix environment) Spearheaded an oncology project from conceptualization to manufacturing.
  • Participated in projects pertaining to Oncology and Metabolic programs in collaboration with Astra Zeneca.
  • Contributed to candidate target selection by Oncology department based on genomic and bioinfor- matic analyses of internal studies.
  • Constructed, expressed and tested many monospecific and bispecific antibodies associated with immuno-oncology, tumor antigens and checkpoint inhibitors.

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16. Hplc

average Demand
Here's how Hplc is used in Principal Scientist jobs:
  • Directed and recommended strategies on forced degradation study design and execution, HPLC method development and validation to satisfy regulatory compliance.
  • Developed and validated stability-indicating HPLC methods for drug substance and drug product.
  • Developed HPLC methods, interpreted data, and served as a consultant for other groups in the company doing permeability studies.
  • Set up analysis instruments (HPLC, GC) for the new laboratory.
  • Transferred and validated test methods from HPLC-MS/MS to UPLC-MS/MS instrument.
  • Invented methods for quantification of multiple vitamins by diode-array HPLC.
  • Developed new HPLC test analysis methods for diagnostic products.
  • Mentored scientists in HPLC development work.
  • Introduced microwave-assisted synthesis, automatic silica gel purification, and prep HPLC instrumentation thatresulted in increase productivity.
  • Developed and validated HPLC-MS/MS method for enzymatic reaction products to replace a radiation imaging method.
  • Developed various reliable HPLC separations including complex impurities method.
  • Supervised research associates who created methods and SOP's for TOC, HPLC, GC, and GC/MS analysis of biofuels.
  • Implemented small/large scale HPLC purifications (DAN Process) with C18 single columns and by SMB technology.
  • Develop and validate analytical chemistry methods for company's products using HPLC, GC and ICP-MS.
  • Initiated HPLC/MS and HPLC/MS/MS, HRMS programs to Analytical Development Group at Hamilton site.
  • Devoloped methods and SOP's for HPLC/MS analysis of biological compounds.
  • Develop HPLC methods to purify lipid ligand conjugates.
  • Established ADC characterization including Chromeleon HPLC (SEC and HIC), ELISA, SPR, and MS.
  • Developed several high sensitive HPLC methods by derivatizing specific functional groups present in analytes with commercially available tagging reagents.
  • Developed several chiral HPLC methods including warfarin.

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17. GLP

average Demand
Here's how GLP is used in Principal Scientist jobs:
  • Assessed blood pressure measurement in toxicology studies in non-rodents and the feasibility of implementation jacket telemetry in GLP toxicology studies.
  • Employed both rat and dog studies for critical GLP toxicology studies needed for IND submission.
  • Developed and validated GLP SEC method for quantification of single strand content in duplex preparations.
  • Instituted Standard Operating Procedures for Quality Control (non-GLP) for liquid handling devices.
  • Provide scientific inputs to the development teams by contributing to contracted GLP toxicology studies.
  • Research and Develop of new methods and validate according to GLP and SOP.
  • Directed and trained associates on writing standard operating procedures in a GLP format.
  • Collaborated with QA and provided regulatory expertise and policy support for GLP.
  • Audit the laboratory for GLP compliance and to USDA and safety requirements.
  • Develop and qualify LCMS methods from early discovery to GLP-like standards.
  • Transferred GLP- compliant assays to Contract Research Organization.
  • Conducted and directed GLP studies in environmental chemistry.
  • Hired and managed GLP Study Directors.
  • Complied with GMP/GLP and safety requirements.
  • Prepare oral solutions/suspensions for GLP toxicology and pharmacokinetic studies.
  • Build an internal non-GLP bioanalytical laboratory.
  • Contributed to the development and execution of a large GLP study to determine small molecules in blood samples using Ion Chromatography.
  • Design, execute, and analyze complex in vitro studies with a focus on safety and GLP compliance.
  • Write, implement SOP's, Methods and Biodesigns for the maintenance and procedural requirements for GLP compliance.
  • Audit the laboratory for compliance to cGMP and GLP.

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18. Data Analysis

average Demand
Here's how Data Analysis is used in Principal Scientist jobs:
  • Performed extensive data analysis functions, while directing the creation and implementation of new measurement systems at various manufacturing sites.
  • Develop reports based on data analysis, customer and presenter feedback, and government/military requirements.
  • Identified and implemented new data analysis and data integration technology to Alzheimer's disease projects.
  • Designed testing apparatus for longevity, managed data collection, and led data analysis.
  • Perform data analysis using statistical tools from development and submission for process understanding.
  • Group Leader for independent study design, data analysis and interpretation.
  • Conducted clinical data analysis, on-call urgent troubleshooting and technical support.
  • Validated algorithms via clinical trial data analysis.
  • Mentored others on technical and scientific areas of expertise including study trial design, data analysis, and scientific techniques.
  • Designed and developed data analysis and mining tools and provided user interfaces for various applications throughout GSK R&D.
  • Performed high-resolution transmission electron microscopy (HRTEM) and X-ray diffraction (XRD) measurements and data analysis.
  • Improved the properties of analogs by using imaginative structure based design, data analysis and library synthesis.
  • Provided NMR metabolic profiles of normal and diseased states for animal studies from multivariate data analysis.
  • Set up high-throughput NMR sample preparation, data collection, and data analysis for clinical samples.
  • Provided support documentation through database searches, data analysis, and safety query responses.
  • Performed custom and routine data analysis for several R&D projects.
  • Developed new TLC Solvent Systems and improved methods of data analysis.
  • Developed a data model and data analysis tools for signal processing, DNA reads handling and identification (Matlab).

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19. Project Management

average Demand
Here's how Project Management is used in Principal Scientist jobs:
  • Program and Project Management: Successful cross-matrix management of early-stage resources and activities as program co-leader for three Therapy area-sponsored programs.
  • Used project management and planning proficiency regarding scientific research programs.
  • Project management - Biology team leadership of several discovery projects.
  • Project management, CRO identification and collaboration.
  • Align scientific/technical components with Project Management.
  • Supervised two (2) offices, responsible for budgeting, personnel, forecasting and project management.
  • PROJECT MANAGEMENT EXPERIENCE Current - Project leader for large pharmaceutical collaboration.
  • Support project management in planning projects time lines.
  • Project management: compiled the project plans by establishing objectives, timelines, budgets, procedures and milestones.
  • Performed project management activities to manage project strategic plan, timeline, cost and analytical developments.
  • Collaborated with multi-disciplinary team consisting of analytical, quality, regulatory and project management.
  • Project management (2 direct reports at the B.Sc.

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20. CMC

average Demand
Here's how CMC is used in Principal Scientist jobs:
  • Contributed technical and regulatory expertise to CMC development project teams, specification review and stability committees.
  • Prepared CMC documentation for global regulatory submissions and responses to health agency inquiries.
  • Prepared technical reports and CMC section compilations for various types of regulatory submissions.
  • Provide leadership (start to end) in defining and implementation of CMC regulatory strategies throughout the life-cycle of the product.
  • Served as the CMC regulatory strategist to senior management and sponsors for the development of pharmaceutical products and devices.
  • Managed the co-ordination, technical writing and compilation of CMC documentation from PD perspective for an IND application.
  • Collaborate with Discovery, CMC, Regulatory, QA and contribute in multiple Nonclinical and Clinical project teams.
  • Lead a CMC team and progressed the development project from candidate selection to phase II clinical trial.
  • Generated, maintained and reviewed drug and device development and CMC documents.
  • Examined CMC section of ANDA submitted for an antihistamine oral solution.
  • Promoted SGEN's ADC CMC strategy in an intensely competitive field.
  • Support the preparation of CMC filings for regulatory submissions.
  • Reviewed the CMC section of SNDA filing.
  • Contributed to CMC section of IND.
  • Coauthored relevant CMC sections of regulatory filings including ANDAs and deficiency/comment letter responses.
  • Play key role as part of CMC interdisciplinary international team with objective to meet critical product development program timelines.
  • Worked with the Entecavir team to support and translate the NDA-CMC for a filing in China.
  • Serve as analytical representative on three program development CMC teams.
  • Authored and reviewed technical documents, SOPs and RegCMC modules.
  • Co-managed continuous improvement of a commercial manufacturing process and ensured regulatory documents including DMFs and IMPDs represented a consistent CMC strategy.

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21. Intellectual Property

average Demand
Here's how Intellectual Property is used in Principal Scientist jobs:
  • Conducted quarterly innovation meetings within the department to discuss invention disclosures and improvements to our current intellectual property portfolio.
  • Participated in the corporate intellectual property and legal defense efforts.
  • Prioritized lead scaffolds and evaluated their intellectual property positions.
  • Established intellectual property which extended the drug life-time.
  • Assessed feasibility of patents and intellectual property.
  • Experience with critical document writing to support IND filing, intellectual property, and publication strategy
  • Managed and developed core intellectual property that formed basis of the spin-off.
  • Directed the intellectual property strategy in machine learning for context awareness and user behavior modeling.

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22. GMP

average Demand
Here's how GMP is used in Principal Scientist jobs:
  • Mentored junior scientists in understanding GMP compliance during process development and scale-up execution and defining optimal design of experiments.
  • Transferred controls to manufacturing for product launch and included all required studies, testing and documentation under GMP guidelines.
  • Lead technical aspects in developing a new GMP laboratory at West Point Merck client site for in-process sample analysis.
  • Developed and maintained KPI's to monitor department systems, progress on initiatives, and GMP compliance.
  • Write documentation for and execute technical transfers of products to clinical grade and CGMP manufacturing.
  • Manage various Release and Stability programs for Pilot/Engineering and GMP lots for clinical trials.
  • Culture of mammalian cell lines for GMP cell banking, production and non-production.
  • Performed immune cell isolation, expansion and activation (in GMP environment).
  • Transferred New Drug Product formulation and manufacturing Processes to GMP Commercial Sites.
  • Interacted with Health Authorities, providing GMP data and responses to commitments.
  • Developed GMP (good manufacturing practices) compliant change control procedures.
  • Designed validation of protocols and implementation of GMP tests.
  • Supervised and coordinated technology transfer by working in close association with manufacturing and QC/QA personnel under cGMP regulations.
  • Maintain overall cGMP facility in compliance: equipment/facility validation and cleaning validation.
  • Accomplished optimization of in-house scale up process, technology transfer to CRO for cGMP manufacture in 2.5 months.
  • Ensured compliance with cGMP, ICH, USP and other pharmacopoeias, and J&J regulations/policies.
  • Provide microbiological training, hygienic manufacturing support and cGMP guidance to R&D and manufacturing sites.
  • Implemented the process chemistry protocol of targeted compounds to cGMP manufacturing method and outsource to CRO.
  • Designed and Prepared proposals and estimates for inquiries regarding contract research, R+D and cGMP manufacture.
  • Evaluated processes provided by clients, improved processes for scalability to plant operations under GMP conditions.

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23. Assay Development

average Demand
Here's how Assay Development is used in Principal Scientist jobs:
  • Support due-diligence and provide expert biology and assay development guidance on Therapeutic Area portfolios.
  • Team Leader: Protein reagent production / assay development for structural biochemistry efforts, and key late stage projects.
  • Generated protein and cellular reagents, performed assay development and mechanism of action studies.
  • Directed day-to-day activities of two assay development scientists as well as five in-house contractors.
  • Managed OEM assay development teams, including protocol development and SR1 software support.
  • Managed and supervised a diverse team of assay development scientists and associates.
  • Led assay development and validation for the HSV vaccine program.
  • Team Leader: Assay development for multiple targets.
  • Delivered analytical expertise for assay development and market launch.
  • Bioassay and Cell based ELISA assay Development.
  • Established and lead new bioassay/immunoassay development laboratories and staff.
  • Engage in early NASH project in-house (model characterization, biomarker and assay development).
  • Identified isoform patterns of Prostate Specific Antigen as part of a collaborative research through sensitive assay development and analyte characterization.
  • Introduced proteomics-based approaches into assay development to improve protein/peptide biomarker quantitation.

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24. NDA

average Demand
Here's how NDA is used in Principal Scientist jobs:
  • Prepared/reviewed Regulatory Standard Operating Procedures.
  • Designed dye calibration standards and signal normalization procedures; designed algorithms and methods to account for temperature/pH effects on emitted fluorescence.
  • Strengthened stakeholder communications across geographic and cultural boundaries, between DTRA and National partners to enhance program effectiveness and results.
  • Provided strategic evaluations of potential targets/compounds as part of internal discovery team efforts and contributed Go/No Go recommendations to management.
  • Directed the development and implementation of many primary and secondary cell-based assays to build confidence in the different targets.
  • Created/Modified Standard Operating Procedures, Detailed Manufacturing Instructions, In-Process and Final QC testing instructions, and Validation documents.
  • Develop and review standard operating procedures and test methods to assure adherence to company policy and current regulations.
  • Documented research findings and analysis results and provided recommendations to senior executive level to guide business decisions.
  • Advised in out-of-specification investigations and provided recommendations in resolving technical issues and to promote continuous improvements.
  • Prepared a SPCC threshold applicability and secondary containment analysis procedure for renewable power facilities.
  • Review acquisition documents for accuracy and completeness and provide recommendations for milestone approval.
  • Involved in many respiratory programs which led to clinical recommendation of several compounds.
  • Study director for new protocols, standard operating procedures and finalized reports.
  • Troubleshooted manufacturing issues, provided recommendations for product salvage and process improvements.
  • Developed and performed confirmation assays and secondary assays for lead confirmation.
  • Project required intense evaluations utilizing a variety of materials testing standards.
  • Presented and made recommendations of new therapeutic targets for arthritis.
  • Reviewed investigation reports, formed conclusions and made recommendations.
  • Characterized reference standards, impurities and degradation products.
  • Developed secondary assay for chemical leads.

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25. QC

average Demand
Here's how QC is used in Principal Scientist jobs:
  • Reviewed and approved all instrument qualification testing by QC analysts.
  • Worked with RA and QC for completion of animal studies; analyzed data, prepared final study reports for USDA submissions.
  • Co-developed IT solutions for mass spec work list generation, data calculation/QC and result reporting.
  • Managed a QC lot release safety-testing program for a human Hepatitis A vaccine.
  • Supervised R&D scientists and the work of QC technicians.
  • Acted as Project QC Manager in his absence.
  • Established QC and release assays.
  • Develop and improve analytical/micro method for QC release, extended characterization of the final product.
  • Set specifications for all aspects of DP and DS manufacturing process in collaboration with QC department.
  • Developed specialized multicolor sorting applications, QC Ab panels, and cloning techniques.
  • Developed a novel and robust rheology QC testing method for monitoring monomer reactivity.
  • Provided contract QC lot release In Vitro and In Vivo assays for the detection of viruses.
  • Optimized growth assays, identified critical steps and equipment, established QC gates and SOPs.
  • Managed to develop SOP for palmitate-BSA reagent for and QC protocol tranfer to manufacturing.
  • SOP writing and review QC Laboratory review for compliance Trouble shooting of various projects.
  • Implemented Powder XRD capabilities in QC department in Port Maitland Manufacturing Site to assay trisodium pyrophosphate.
  • Dye Labeled Terminators and DLPAs: Developed synthesis, purifications and QC procedures for Cyanine dye labeled terminators and DLPAs.

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26. Pk/Pd

average Demand
Here's how Pk/Pd is used in Principal Scientist jobs:
  • Developed a short term antigen-specific model to address PK/PD and target occupancy.
  • Supported AMG 900, a pan-aurora kinase inhibitor for solid tumors, clinical development by providing expertise in PK/PD.
  • Strategized and managed the PK/PD program with internal collaborations including chemistry, DMPK, formulation and toxicology.
  • Represent clinical pharmacology function at global project teams to provide clinical PK/PD expertise.
  • Design and execution of PK/PD study and data modeling to derive PK/PD driver & target for prediction of clinical trial dose.
  • Organize raw data within Analyst and prepare reports utilizing Watson PK/PD modeling software as well as in-house software for report generation.

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27. Technical Support

average Demand
Here's how Technical Support is used in Principal Scientist jobs:
  • Provide technical support for manufacturing troubleshooting activities.
  • Provide technical support to Technical Services and Sales to address specific customer issues or information requests, and sales training.
  • Provided technical support for substantiation of complex fruit content claims for Nabisco Fig Newtons A/P campaign vs. competition.
  • Provide in depth technical support and method development when default methodologies do not work.
  • Maintain client relationship by providing technical support to projects.
  • Provided technical support for periodical updates of transcript sets.
  • Provided technical support in the environmental management area to Magna Copper Company for development of their new underground mine in Arizona.
  • Participate in product development teams, supporte technical transfer to manufacturing facility and provide technical support to manufacturing group.
  • Participate or Provide technical supports on investigations using mass spectrometry
  • Coordinated Worldwide Technical Support for the SR1 Immunoassay Analyzer.
  • Provide technical support in resolving Solstice yf product quality issues and customer complains.

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28. DNA

average Demand
Here's how DNA is used in Principal Scientist jobs:
  • Evaluated novel circulating tumor DNA applications using next generation sequencing for patient selection strategies.
  • Optimized DNA quantification via fluorescent methods.
  • Designed and developed a DNA mapping pipeline, mapping engines, and an incremental system update.
  • Researched new DNA sequencing algorithms to increase read length of ABI's fluorescence-based DNA sequencers.
  • Identified critical DNA sequence in the promoter that served as a target.
  • Calculated dynamic DNA confidence values.
  • Managed efforts to implement and validate alternative printed circuit boards used in a marketed DNA-array based genetic diagnostic test.
  • Optimized DNA extraction from human and animal samples and set up a medium throughput lab process.
  • Isolated the rare genes and novel members of gene families from normalized cDNA libraries.
  • Invented and developed of technologies for construction of subtracted and normalized cDNA libraries.
  • Project Manager for the product development of two DNA-based in vitro diagnostics.
  • Employed use of ABI 7500 Fast sequencing and MagMax automatedgDNA extraction systems.
  • Developed technologies for 96-well format High-Throughput gene isolation from cDNA libraries.
  • Constructed highly enriched full-length cDNA libraries.
  • Supervised and performed fungal and bacterial identification with polyphasic approaches incorporating biochemical characterizations and genetic analysis with 16S & 28S/ITS r-DNA.
  • Established a startup focusing on antibody based multiplexed DNA/RNA protein interactions and signal transduction pathway analysis platform development.
  • Provided guidance to engineering team regarding DNA behavior in nano- and microfluidic systems.
  • Constructed cDNA libraries with microscale mRNA.
  • Led the development of an NGS ampli-seq assay for the detection of deletions on mitochondrial DNA which use breakpoint as targets.
  • Optimized lyophilization of asDNA parenteral formulations, and oral formulations Manufactured linkers used to attach synthetic antisense DNA to proteins.

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29. Business Development

average Demand
Here's how Business Development is used in Principal Scientist jobs:
  • Worked closely with Business Development offering technical expertise and provided solutions to satisfy non-- routine client requests.
  • Provided operational and scientific expertise to Research and Business Development.
  • Utilized research results to discover business development partners and investors.
  • Collaborated with internal business development, corporate R&D groups, and outside experts in the renal field.
  • Contributed to business development of diagnostics and biomarkers for cancer, cardiovascular disease and autoimmune disease.
  • Collaborated with business development group to out-license the compound to Takeda.
  • Managed multiple external University, New Business Development and Preclinical CRO contracts totaling > $2.5M.
  • Consult with marketing and business development groups on newareas for growth.

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30. DOE

low Demand
Here's how DOE is used in Principal Scientist jobs:
  • Utilize DOE to find optimal product compositions and processes Supervise two chemists Accomplishments Developed new line of hydrogenated hydrocarbon resins.
  • Carried out Process Chemistry Justification experiments utilizing DOE software and automated equipment, as well as traditional techniques.
  • Developed cost & risk models for technology development projects based on DoE/DoD Technology Readiness Levels.
  • Developed and implemented experimental test plans according to DOE.
  • Authored 15 SBIR proposals with creative and unique solutions to energy related technical problems faced by NASA, DOD and DOE.
  • Contributed to research collaborations in quantum computing and timing/synchronization in particle accelerators, with funding from IARPA and DOE.
  • Procured and managed $2.5M contract with DOE studying wear performance for the strip mining industry.
  • Studied and optimized process parameters and film qualities with DOE and SPC approach.
  • Proposed life cost model for hydrogen fuel cells as a part of research grant to DoE resulting in funding.
  • Implemented QbD and DOE approaches into analytical method development projects.
  • Developed computational model of ion source/Hall thruster Funded for Phase I SBIR from DoE on active microwave media.
  • Funded for Phase I DOE SBIR on use of FPGA based Kalman filter for particle accelerator control applications.

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31. Drug Candidates

low Demand
Here's how Drug Candidates is used in Principal Scientist jobs:
  • Performed forced degradation study and designed experiments to elucidate degradation pathways of drug candidates under various conditions.
  • Synthesized potential drug candidates in for treatment of inflammatory disorder for GlaxoSmithKline (GSK).
  • Lead Project Chemist for Two Drug Candidates for CGRP Project.
  • Investigate mechanism of action of drug candidates.
  • Evaluated neurotoxicity of known chemotherapy drugs versus cancer drug candidates in a mouse model.
  • Prepared preclinical reports for IND filing of 3 drug candidates (1 currently in Phase I).
  • Managed internal inflammation, PK and tolerability studies with small molecule drug candidates, including VCAM-1 antagonists.
  • Conducted salt screens for both drug candidates and identified HCl salt as the final form.
  • Research results have moved company's tumor drug candidates through research and pre-clinical development stage.
  • Studied cellular activity of related peptide drug candidates to better understand the mechanism of action.
  • Led cross-function team to deliver preclinical package to guide clinical development of drug candidates.
  • Involved in screening and selection of drug candidates for preclinical development Cross-functional team management
  • Relocated to Boston), Responsible for MOA research and assay development for anti-cancer and anti-fibrotic recombinant protein drug candidates.

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32. New Technologies

low Demand
Here's how New Technologies is used in Principal Scientist jobs:
  • Research and program management on programs primarily related to developing new technologies and products for chemical identification and decontamination.
  • Conduct proof of concept experiments to demonstrate the feasibility and utility of new technologies consistent with Company business interests.
  • Led university collaborations for development of light driven technologies, providing additional capability accelerating development of new technologies.
  • Collaborated with business units, designing consumer evaluation of new technologies for consumer benefits and business opportunity.
  • Explored three new technologies and oversaw preparation of representative prototypes for consumer testing.
  • Collaborated with internal customers and external vendors to develop and implement new technologies and tools, such as MultiMax IR.
  • Worked directly with GSK's commercial and academic vendors and suppliers to leverage new technologies to the company's advantage.
  • Core team member of inter-dependent teams creating new technologies for consumer skin cleansing and care products.
  • Researched and evaluated new technologies and their future application to drug R&D.
  • Investigate, create and develop new technologies and processes and pursue IP generation.
  • Designed test methods to support performance claims for new technologies.
  • Evaluated new technologies and performed due diligence for acquisitions.
  • Develop new technologies for measuring vaccine antigen epitope density and potency.
  • Evaluated of new technologies to drive assay volumes into the 2-8 uL range.
  • Established new technologies (i.e.
  • Identified new technologies for different agro ecological zones and chalked out programme of work for next crop seasons.
  • Developed new technologies and analytical methods for formulations and raw materials in joint development programs with clients ( i.e.

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33. Research Projects

low Demand
Here's how Research Projects is used in Principal Scientist jobs:
  • Conceived and led multiple original technology research projects for example needless injection technology and electrostatic mixing technology.
  • Designed, supervised and performed Microbiology research projects on food Microbiology safety and quality issues.
  • Worked with more than 100 NASA and Lockheed customers in different research projects.
  • Managed multiple basic research projects.
  • Planned and directed internal and external research projects from inception to preclinical candidacy.
  • Direct and coordinate key research collaborations and outsourced research projects with external groups worldwide to meet company defined goals and timelines.
  • Managed the outsourcing activities with CROs for peptides and other designed molecules in support of research projects.
  • Acquired new NMR spectrometer to enhance the analytical capability in support of all on-going research projects.

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34. Formulation Development

low Demand
Here's how Formulation Development is used in Principal Scientist jobs:
  • Performed formulation development, reviewed patent and evaluated technology issues, especially, for the novel delivery systems.
  • Prepared reports on Formulation development, new technologies and business opportunities.
  • Played a major role in spray dried powder protein formulation development.
  • Lead analytical activities to support formulation development and clinical trial supply manufacturing on multiple projects.
  • Conducted GC and HPLC analysis of preformulation and formulation development samples.
  • Execute analytical testing supporting formulation development studies.
  • Led the liquid/lyophilized clinical service formulation development for Phase 1 and Phase 2 projects.
  • Support formulation development and stability studies of mAb (high concentrations), pDNAs, viral vectors, and conjugates.
  • lead scale-up of Rezulin employing hot melt technology) Responsible for formulation development, scale-up and technology transfer to manufacturing site.

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35. Sbir

low Demand
Here's how Sbir is used in Principal Scientist jobs:
  • Authored and oversaw a Phase II Small Business Innovation Research (SBIR) grant, funded for $1.2M.
  • Used SBIR contracts to build the team, conduct sponsored research, and develop commercial products.
  • Provided technical support on a variety of SBIR projects spanning a variety of areas.
  • Prepared and submitted patent application and SBIR colon cancer grant application.
  • Developed custom embedded software for specialized military SBIR programs: Non-lethal strobe light to defeat laser-targeted, surface-to-air missiles.
  • Discovered the ability of technology to enhance antiseptics and secured Phase I SBIR grant for the development of this application.

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36. Technical Reports

low Demand
Here's how Technical Reports is used in Principal Scientist jobs:
  • Increased reliability of investigations, technical reports, and remediation protocols of homes experiencing moisture problems and fungal growth.
  • Create protocols, technical reports, installation/operational qualifications, and validations of various laboratory instruments and equipment.
  • Coordinate and lead field investigations, analyzed data and compiled technical reports.
  • Supervised coordinated, reviewed results and prepared technical reports for the qualifications.
  • Prepare technical reports, publications and oral presentations.
  • Published 28 Eastman Chemical Company internal technical reports.
  • Review all data and technical reports and make recommendations on next steps and follow up studies.
  • Assist in technical review of batch records for lot release, draft scientific and technical reports.
  • Prepare technical reports, SOP s, IACUC and IBC applications, and scientific papers.
  • Lead technical writer for new funding proposals, technical reports, and corporate marketing/messaging efforts.
  • Provide review/oversight on analytical data, technical reports, and deviations/investigations.
  • Lead field investigations, analyzeddata and compiled technical reports.
  • Completed product characterization studies and technical reports supporting Atrovent HFA NDA submission.
  • Group Leader: Knowledge Management Executive Forumo Direct Technical Reports: 8 chemists/Chemical Engineers (MS/PhD).

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37. Raw Materials

low Demand
Here's how Raw Materials is used in Principal Scientist jobs:
  • Pioneered reduced testing program implementation for incoming raw materials reducing 10% laboratory operation cost.
  • Developed supply strategies for raw materials and downstream intermediates used globally by Chemical Development.
  • Provided hazardous assessment on raw materials and process condition prior to and during manufacturing.
  • Authored control procedures and validation reports for raw materials and intermediates.
  • Developed solutions for manufacturing problems and raw materials quality assessment.
  • Develop methods, techniques and evaluation criteria for all raw materials, components, in-process intermediates, and finished products.
  • Focus on bio-derived raw materials for the development of new products or modification of existing ones.
  • Redesigned a GC-MS method for detailed raw materials characterization, allowing fine-tuning of the chemical development and manufacturing processes.
  • Performed dedicated research on new product technologies and formulations with focus on naturally positionedproducts and raw materials.
  • Developed and simplified laboratory techniques for incoming raw materials inspection, improving operational efficiency and ensuring quality materials
  • Generated raw materials and developed immunoassays for several renal biomarkers.

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38. Study Protocol

low Demand
Here's how Study Protocol is used in Principal Scientist jobs:
  • Contributed to the design of the animal study protocols.
  • Reviewed and provided input into biomarker section of clinical study protocols.
  • Inspected and selected CROs, developed study proposals, reviewed and edited the study protocols and reports.
  • Design, develop and review study protocols and reports to ensure scientific rigor.
  • Prepared study protocol and working procedures for conducting clinical studies according to the relevant regulations.
  • Executed formulation and process development study protocols, stability and product characterization studies.

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39. SAR

low Demand
Here's how SAR is used in Principal Scientist jobs:
  • Identified, designed and implemented product improvements necessary to launch product.
  • Provide necessary reporting tools to demonstrate program effectiveness.
  • Designed and implemented chemistry plans to drive SAR, improving potency and selectivity in combination with optimizing DMPK and ADME properties.
  • Validated target and developed cell-based assays that were used to screen compounds and drive SAR.
  • Updated designs as necessary to meet timing requirements as well as correct functionality.
  • Acquire or make necessary type of vehicle required for each compounds formulation.
  • Perform labeling of all collection vials as necessary for each study.
  • Maintain sample matrix in all strains necessary for DMPK analyst work.
  • Set up the necessary selectivity assays.
  • Organize compound acquisition and delivery to Safety Assessment including formulation calculations using helium or net peptide content as necessary.
  • Manage projects for product development such as developing skin closure devices for Caesarian-sections.
  • Led successful turnaround of underperforming employee through coaching; saving company thousands of unnecessary dollars in hiring and training process.
  • Designed and synthesized a new series of back up compounds for a pre-clinical program based on SAR and toxicity studies.
  • Key contact with major contract service provider of essential antibodies, peptides and control reagents necessary for assay development.
  • Optimized an HPLC/MS method to monitor enzymatic inhibitors of PCSK9 cis-cleavage and provide information critical for SAR.
  • Created all necessary biological tools and developed high throughput assay for ligands of the receptor.
  • Developed QSAR models for the prediction of ADME/PK properties.
  • Devised and synthesized key analogs to probe the SAR around oncogenic kinase targets.

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40. PCR

low Demand
Here's how PCR is used in Principal Scientist jobs:
  • Collaborated with computational chemistry group to model drug interaction with GPCR targets.
  • Identified activators of an orphan GPCR and led compound development resulting in a collaboration with a large pharmaceutical partner.
  • Led a custom GPCR assay development group that built over 30 stable cell lines for clients.
  • Invented of PCR enhancer for amplification of GC-rich DNA molecules and sequencing high GC template DNA.
  • Filed a method patent application on a cellular assay technique developed for GPCR assays.
  • Identified potent proprietary lead from HTS hits for a GPCR target for diabetes.
  • Performed PCR based assays and DNA Synthesis to manufacture in-process testing reagents.
  • Utilized these data to direct counter screens for GPCR targeted projects.
  • Used machine learning to improve quality of multiplex PCR.
  • Cloned genes using PCR techniques for project progression.
  • Conceived and developed a highly robust and automated web tool for in-silico PCR specificity analysis with advanced proprietary sequence analysis algorithms.
  • Managed two additional discovery/development projects for GPCR antagonists and one project for recombinant protein inhibitors of complement activation.
  • Designed and developed qPCR instrument/reagent validation programs for manufacturing.
  • Supported enzymatic down-selection and design of a rapid One-Step RT-PCR module from high background samples (Blood) on Microfluidic Cartridge.
  • Extract RNA from an exploratory mouse study and test for four genes/cell markers using qPCR.
  • Provided technical and project leadership to advance PCR development in new genetic diagnostic tests.
  • Developed successful screening strategies for multiple targets, including Class B and orphan GPCRs.
  • Analyzed genomic DNA by PCR to show integration and RT-PCR to prove expression.
  • Worked with biologics group to develop activating antibodies for a GPCR target.
  • Developed various Long Range PCR products for sequencing on Oxford Nanopore MinION.

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41. Dmpk

low Demand
Here's how Dmpk is used in Principal Scientist jobs:
  • Selected as DMPK Project Manager for an Obesity project team working to select and advance a compound into development.
  • Acted as primary liaison to biochemistry, DMPK and pharmacology departments, and to external contract research organizations.
  • Adopted and established the cutting edge DMPK technologies to expand the functions of DMPK group.
  • Collaborated with leaders from CV biology, process chemistry, DMPK and structural chemistry.
  • Directed technical staff to support DMPK studies solving issues of oral exposures.
  • Served as DMPK program representative on an antimicrobial program.
  • Solved major DMPK challenges for this series of compounds.
  • Served as DMPK representative on cross-functional project teams.
  • Introduced Zymate II laboratory automation system at DMPK Department and developed several liquid/liquid and liquid/solid extraction sample preparation methods.
  • Provided radiolabel drugs, developed DMPK methodology with stability indicating, validated LC-MS/MS protocols.
  • Led method development, study design, and execution of drug metabolism and pharmacokinetic (DMPK) studies using LC-MS/MS.
  • Performed QC and presented stability and DMPK data from parenteral biologics, to senior managers.

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42. Elisa

low Demand
Here's how Elisa is used in Principal Scientist jobs:
  • Developed a novel sandwich ELISA that unequivocally validated the company's lead diabetes compounds.
  • Developed and qualified ELISA and cell-based assays for the safety assessment of neutralizing antibodies in preclinical studies.
  • Characterized mono- and poli-clonal antibodies to establish an ELISA assay capable to recognize Aggrecanase activity in Osteoarthritis models.
  • Developed and validated ELISAs for quantification of biologic drugs for pharmacokinetic analysis.
  • Tested ELISA technique for the detection of methylated guanine nucleobases rodent lung cancer studies.
  • Develop & validate ELISA based biomarker assays to analyze clinical & preclinical samples.
  • Developed ELISAs for novel IVD in-solution immunoassay platform.

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43. HTS

low Demand
Here's how HTS is used in Principal Scientist jobs:
  • Secured intellectual property rights by drafting a patent application covering our invention with patent attorneys.
  • Led cross-functional innovation team to generate regional consumer insights for development of a short and long term global oral health pipeline.
  • Validate HTS cell-based assays that have been transferred from other research groups or generated internally with the HTS Core group.
  • Coordinated three engineers and five project staff in developing detection coding and oversaw execution of field experiments during aircraft flights.
  • Received Award of Excellence from Vaccine Basic Research Group for leadership of ultra HTS campaign in 2013.
  • Research, develop, evaluate and implement novel HTS methods in cell lines and/or invertebrate organisms.
  • Provided recommendations and valuable insights on assessing the quality and importance of Web flow design.
  • Conducted rifle firing tests to analyze shock and vibration effects on intensified rifle sights.
  • Set up protocols for the HTS/HCS of compounds that inhibit influenza virus replication.
  • Designed & Developed High Quality, Cell-based and Enzymatic, HTS Assays.
  • Established, validated and integrated the FLIPR-384 HTS CRS robotic system.
  • Selected Highlights: Led program development through rapid growth period.
  • Developed robotic methods for compound screening (HTS).
  • Developed a method combining TEM, SEM, AFM, AES and MOI to identify defects in the HTS.
  • Participated in various cross-functional teams, contributed insights and provided peptide/protein chemistry leadership support to research projects.
  • Purified sufficient quantities of Tryptase from Human Lungs to allow assay validation and HTS to be completed months ahead of schedule.
  • Structure based drug design, was combined with solution phase combinatorial chemistry and HTS, to discover next generation NS5B inhibitors.
  • Guide the selection of lead series & lead compounds by in Silico analysis, HTS and manual screen data.
  • Project Highlights: Served as lead investigator on design of millimeter wave personal screening system utilizing scanning mirror design.
  • Triaged HTS hits, then developed numerous new series which possessed superior activity to a previously optimized series.

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44. Pfizer

low Demand
Here's how Pfizer is used in Principal Scientist jobs:
  • Followed by examining the relationship of promiscuity measure to toxicity using a Pfizer proprietary compound set.
  • Nominated for 2014 Great Manager Award, which represents the top 10% of Pfizer managers.
  • Recruited to Pfizer and successfully started molecular biology laboratory to study gene expression in pre-clinical drug studies.
  • Recognized as the go to expert within global Pfizer, within one year, for microRNA assessments in drug safety studies.
  • Led focus group on hepatocellular carcinoma and gastric cancer to advance Pfizer's Asia strategy.
  • Managed the Multiple Sclerosis Research Group at Pfizer Biotherapeutics.
  • Developed the ?-Insulin Receptor Kinase biochemical assay for Pfizer's Kinase Selectivity Panel.
  • Coordinated outsourced testing and AMTEs with Analytical R&D from Groton and other Pfizer sites.
  • Directed the first 4 pharma-partnering projects with Pfizer, Pharmacia, Chiron, and Roche.

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45. QA

low Demand
Here's how QA is used in Principal Scientist jobs:
  • Served as microbiology technical expert to support QAT and Validation departments.
  • Worked with laboratory management and QA to develop, author and implement formal procedures SOP, s defining laboratory work process.
  • Led the QA Communication team in defining communication issues which led to 5 sub teams to improve communication within QA.
  • Follow and enforce all strict QA/QC guidelines for a large government contract, corrected deficiencies, and applied data qualifiers.
  • Collaborated with internal (Product Development, Molecular Biology, QA/QC and Manufacture) departments and external clients.
  • Worked closely with QA Technical (QAT) and Manufacturing groups to resolve contamination problems.
  • Key team member of the QA Training Team which created the QA training program.
  • Performed safety audits to QA Labs to minimize accidents and near misses.
  • Confirmed calibration measuring and testing equipment QA for work packages.
  • Performed Failure and Defect Analyses for QA Dept.
  • Served as Environmental Business Unit Leader and Chief Scientist for Alaska Operations; including oversight ofQA/QC Program Compliance\Training.
  • Validated and reviewed data assuring compliance to QA/QC protocols.
  • Developed numerous UFP-QAPPs in a timely manner.
  • Implemented QA/QC, compliances, licenses, SOPs for 30Ksqft AAALAC facilities.

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46. Animal Models

low Demand
Here's how Animal Models is used in Principal Scientist jobs:
  • Monitored the scientific literature; recommended new disease indications, appropriate animal models and experimental designs; performed statistical analyses.
  • Established screening cascades ranging from biochemical/cellular assays to animal models.
  • Designed and synthesized novel, potent compounds that showed excellent physical properties and favorable PK properties in animal models.
  • Skilled in multiple dosing/bleeding techniques with multiple animal models mouse, rat, rabbit, dog, marmoset monkey.
  • Skilled in multiple tissue collection sites in multiple animal models.
  • Supervised the in vivo team to establish animal models for kidney fibrosis to validate lead compounds.
  • Established animal models of age-related macular degeneration, glaucoma and ischemia-reperfusion retinal damage.
  • Demonstrated first in vivo retroviral vector-mediated expression of therapeutic levels of Factor VIII in nonsyngeneic animal models.

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47. Patent Applications

low Demand
Here's how Patent Applications is used in Principal Scientist jobs:
  • Supported development and submission of patent applications and advised senior management on upcoming technologies.
  • Lead the patentability of key concepts for 13 patent applications filed.
  • Generated critical efficacy data used to support the submission of 3 novel chemistry patent applications.
  • Evaluated techno-commercial feasibility for documenting invention disclosures and filing patent applications.
  • Published patent applications for a number of new laser designs as the first author.
  • Lead inventor on three patent applications that will be published in 2015.

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48. Phase II

low Demand
Here's how Phase II is used in Principal Scientist jobs:
  • Managed team for establishing in-house HeLa cell line-based system to produce AAV-sFLT01 vectors for AMD gene therapy clinical trial Phase II.
  • Performed UPLC impurity method validation for clinical phase III readiness of the lead DPI product development.
  • Functioned as Sub-Investigator on two Phase II clinical studies under an IND.
  • Process development and scale-up of TTP435 (Phase II).
  • Participated in development strategies and provided guidance to support development of NCEs from Phase I/II to Phase III/Commercial.
  • Assisted in the performance of Phase I and Phase II environmental assessments.

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49. Direct Reports

low Demand
Here's how Direct Reports is used in Principal Scientist jobs:
  • Led one supervisor as direct report and 12 technicians as indirect reports, overseeing all toxicology aspects of assigned Ophthalmology projects.
  • Conduct mid-year and year-end performance review for direct reports; participate in hiring process throughout the screening, interview and selection.
  • Led a team of 15 direct and indirect reports that totaled over 5 million dollars in scientific research funding.
  • Hired, trained and mentored several direct reports as well as others in the department.
  • Managed groups of up to 7 direct reports and budgets up to $1.8 MM.
  • Manage two direct reports (Research Scientist and Senior Scientist).
  • Oversee the daily activities and development of two direct reports.
  • Mentored direct reports on ADME science concepts and impacts.
  • Managed performance and career development of 5 direct reports.
  • Led 5 direct reports (PhD & MD research directors) with P&L oversight.
  • Managed staff of 5 direct reports (PhD and MS scientists).
  • Leaded analytical supports, mentored direct reports and delegated resources for projects assigned to the laboratory 2.

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50. Stability Samples

low Demand
Here's how Stability Samples is used in Principal Scientist jobs:
  • Assumed area management of stability chambers, initiated critical work to be performed, and reviewed physical inventory of stability samples.
  • Prepared gap method validation report and tested stability samples for dissolution of soft gelatin capsules using Apparatus-III.
  • Initiated stability study; pulled stability samples and tested according to approved procedures and specifications.
  • Analyzed physical and chemical testing of product stability samples in accelerated conditions.
  • Tested routine stability samples in managing stability program.
  • Reviewed test records for the release of the stability samples.

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20 Most Common Skill for a Principal Scientist

Analytical Methods12.9%
Regulatory Documents8.3%
Drug Discovery8.1%
R7.2%
Medicinal Chemistry6.8%
Protein5.2%
FDA5.1%
New Product Development5.1%

Typical Skill-Sets Required For A Principal Scientist

RankSkillPercentage of ResumesPercentage
1
1
Analytical Methods
Analytical Methods
8.9%
8.9%
2
2
Regulatory Documents
Regulatory Documents
5.7%
5.7%
3
3
Drug Discovery
Drug Discovery
5.6%
5.6%
4
4
R
R
5%
5%
5
5
Medicinal Chemistry
Medicinal Chemistry
4.7%
4.7%
6
6
Protein
Protein
3.6%
3.6%
7
7
FDA
FDA
3.5%
3.5%
8
8
New Product Development
New Product Development
3.5%
3.5%
9
9
Cros
Cros
3.5%
3.5%
10
10
Clinical Trials
Clinical Trials
3.3%
3.3%
11
11
Drug Products
Drug Products
3%
3%
12
12
Small Molecules
Small Molecules
2.7%
2.7%
13
13
API
API
2.6%
2.6%
14
14
IND
IND
2.3%
2.3%
15
15
Oncology
Oncology
2.1%
2.1%
16
16
Hplc
Hplc
1.9%
1.9%
17
17
GLP
GLP
1.9%
1.9%
18
18
Data Analysis
Data Analysis
1.9%
1.9%
19
19
Project Management
Project Management
1.7%
1.7%
20
20
CMC
CMC
1.7%
1.7%
21
21
Intellectual Property
Intellectual Property
1.6%
1.6%
22
22
GMP
GMP
1.6%
1.6%
23
23
Assay Development
Assay Development
1.4%
1.4%
24
24
NDA
NDA
1.4%
1.4%
25
25
QC
QC
1.3%
1.3%
26
26
Pk/Pd
Pk/Pd
1.2%
1.2%
27
27
Technical Support
Technical Support
1.2%
1.2%
28
28
DNA
DNA
1.1%
1.1%
29
29
Business Development
Business Development
1.1%
1.1%
30
30
DOE
DOE
1.1%
1.1%
31
31
Drug Candidates
Drug Candidates
1.1%
1.1%
32
32
New Technologies
New Technologies
1%
1%
33
33
Research Projects
Research Projects
1%
1%
34
34
Formulation Development
Formulation Development
1%
1%
35
35
Sbir
Sbir
1%
1%
36
36
Technical Reports
Technical Reports
1%
1%
37
37
Raw Materials
Raw Materials
1%
1%
38
38
Study Protocol
Study Protocol
0.9%
0.9%
39
39
SAR
SAR
0.9%
0.9%
40
40
PCR
PCR
0.9%
0.9%
41
41
Dmpk
Dmpk
0.9%
0.9%
42
42
Elisa
Elisa
0.9%
0.9%
43
43
HTS
HTS
0.9%
0.9%
44
44
Pfizer
Pfizer
0.9%
0.9%
45
45
QA
QA
0.8%
0.8%
46
46
Animal Models
Animal Models
0.8%
0.8%
47
47
Patent Applications
Patent Applications
0.8%
0.8%
48
48
Phase II
Phase II
0.7%
0.7%
49
49
Direct Reports
Direct Reports
0.7%
0.7%
50
50
Stability Samples
Stability Samples
0.7%
0.7%

23,835 Principal Scientist Jobs

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