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Top 50 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, 9.0% 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.

These Are The Most Important Skills For A Principal Scientist

1. Analytical Methods
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high Demand
Here's how Analytical Methods is used in Principal Scientist jobs:
  • Team lead responsible for identifying ICH deficiencies in analytical methods and validation documents supporting marketed products tested by GPSG.
  • Summarized analytical methods used in 100 articles focused on spatial analysis of elections.
  • Evaluated and validated pharmaceutical analytical methods for use in quality control laboratory.
  • Trained individuals on analytical methods and instrumentation; troubleshot instruments where needed.
  • 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.
  • Transfer analytical methods from R&D site to GMS site.
  • Updated validation of analytical methods as needed in compliance with JP.
  • Transferred the analytical methods to contract laboratories and other GSK facilities.
  • 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.
  • Develop bioanalytical methods for free and liposome encapsulated forms of novel small molecule drug.
  • Lead QbD work of analytical methods in a chromatography as well as dissolution perspective for Carvedilol CR and Carvedilol/Lisinopril product.

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156 Analytical Methods Jobs

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2. Regulatory Submissions
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high Demand
Here's how Regulatory Submissions is used in Principal Scientist jobs:
  • Review relevant laboratory documentation (individual documents and reports) and related documentation in support of regulatory submissions.
  • Authored and reviewed pharmacology section of regulatory documents for US and global regulatory submissions.
  • Collaborated with regulatory groups to produce high quality regulatory submissions, updates and responses.
  • Collaborated with cross-functional team members to support regulatory submissions of acquired medical devices.
  • Support regulatory submissions, FDA and other geographic regulatory audit and inspection.
  • Provided deep technical understandings in preparation of regulatory submissions.
  • Supported several successful regulatory submissions for commercial organisms.
  • Contributed to IP and regulatory submissions.
  • Achieved 95% on-time delivery of Quality deliverables for Regulatory submissions.
  • Revamped an ineffective technical documentation process driving regulatory submissions.
  • Developed biocompatibility sections for regulatory submissions to FDA (Center for Devices and Radiological Health (CDRH)).

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175 Regulatory Submissions Jobs

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3. Drug Discovery
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high Demand
Here's how Drug Discovery is used in Principal Scientist jobs:
  • 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.
  • Co-developed novel cell-based drug discovery platform for human and viral targets.
  • Collaborated and advised on other drug discovery programs within the company.
  • Developed/validated animal models for five drug discovery groups.
  • Identified troubled protein reagents, proposing new constructs with correct biochemical properties for drug discovery and development.
  • Directed the implementation of a compound plating and storage system to support our internal drug discovery efforts.
  • Co-led Stem Cell Target team organized to develop uses for stem cells in cardiovascular drug discovery.
  • Lead and conduct drug discovery projects for liver cancer, obesity and diabetes treatments.
  • Led and trained a small group of scientists in the drug discovery department.
  • Propose and implement ADME/PK strategies for multiple drug discovery project teams.
  • 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.
  • Modified cell-based assays for use in epithelial cells and primary cardiomyocytes for cardiovascular drug discovery.
  • Study director for drug discovery and development, lead optimization, pre-nomination of lead drugs based on a safety perspective.
  • Design and coordinate drug discovery efforts from ideation to first in human clinical trials (Phase II).
  • Established the Raritan Drug Discovery Target and Project Presentation Series (Peer Assist Program).
  • Provided core physico-chemical data on compounds in support of CNS drug discovery.
  • Partner with Drug Discovery effort with Contract Research Organizations (CROs).
  • Developed several biochemical assays in our drug discovery group for several projects (both in vitro and in vivo).

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798 Drug Discovery Jobs

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4. R
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high Demand
Here's how R is used in Principal Scientist jobs:
  • Optimized achievement of organizational strategic goals, including continuous quality improvements and reduced-cost operations, by actively creating/implementing change control requests.
  • Performed forced degradation, similarity, comparability and stability studies of drug substance and drug products.
  • Function as Facility Manager for Efficacy (Functionality/Pharmacology) and Toxicology Groups.
  • Manage multiple projects, either executed internally or externally.
  • Demonstrate a genuine interest and actions in developing individuals and team not only for short-term success but for long-term bench strength.
  • Ensured appropriate completion of compliance documentations (QAR, Validation and Controlled Document Preparation and Approvals), and GMP compliance.
  • Propose and design research & development projects & execute resource planning and originate, design, conduct and/or direct surgical investigators.
  • Serve as an internal consultant on interaction of various tissues with medical devices.
  • Perform research and testing which support development of products or procedures.
  • Function as Study Director for product evaluations.
  • Manage budgetary requirements for all preclinical research projects and prioritize projects across functions to support internal and external studies.
  • Provide surgical expertise during research, development and evaluation utilizing animate, inanimate, and cadaveric models.
  • Originate, design, conduct, and/or direct surgical investigations for product development and preclinical evidence generation.
  • Co-authored and coordinated reviews of analytical protocols and reports for the contribution of the filing to BLA.
  • Develop project plans and coordinate plans with both the larger project team and other preclinical associates.
  • Validated system and used technical writing skills to develop SOPs.
  • Executed Pilot and Validation Lots under cGMP requirements.
  • Worked in collaboration with project team to devise best strategy for implementing oligonucleotide purification processes.
  • Performed peptide mapping digestion and UV-based analysis and developed amino acid analysis by RP-UPLC.
  • Serve as Preclinical Project Director, Business Unit Leader, and Preclinical IIS Study approver for Bio-surgical products.

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5. Medicinal Chemistry
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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.
  • Provided technical leadership for several lead optimization medicinal chemistry projects.
  • Contract research in medicinal chemistry for national and international clients.
  • Founded the Medicinal Chemistry and Automation Group (MCAT): Led a group ranging up to six chemists.
  • 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.
  • Presented the results at the Global Medicinal Chemistry and Discovery Technologies Meeting.
  • Provided the company with diverse medicinal chemistry services as in previous employments.
  • Utilized medicinal chemistry skills to advance four projects.
  • Manage contract manufacturers for Medicinal Chemistry Optimization, Scale-up Synthesis, Pharmacokinetics and Stability.
  • Project team leader for medicinal chemistry route evaluation, and subsequent process research for kilo lab non-cGMP and cGMP campaigns.

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161 Medicinal Chemistry Jobs

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6. Protein
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high Demand
Here's how Protein is used in Principal Scientist jobs:
  • Led an exploratory research program investigating a novel protein up through target validation.
  • Developed novel purification procedures for different proteins including monoclonal antibodies.
  • Conducted in process and release testing for protein vaccine products, including % purity, and residual detergent analysis.
  • Led a team to develop Java modules to display protein sequences and structures.
  • Developed a database for query of three dimensional protein structures and properties.
  • Developed a novel process for production of algal protein isolate.
  • Advised pre-clinical and clinical teams in identifying and monitoring potential protein-based markers.
  • Target protein expression, refolding, purification and co-crystallization for ligand design.
  • Patented a random-mutagenesis method for the detection of functional protein domains.
  • Semi-automated a homology modeling and refinement process for protein structures.
  • Developed protein separation methods using size exclusion chromatography.
  • Participated in protein purification of biopharmaceutical products.
  • Introduced MS guided purification instrumentation (Waters AutoPure with MassLynx) and optimized it for HTP purification of proteins and peptides.
  • Lead technology development for high protein hot fill pouches and cocoa based retort processed energy shots.
  • Set up a state-of-the-art Center of Excellence for Peptide & Protein Characterization and Early Formulation.
  • Devised an algorithm for the ab initio folding of alpha helix structures for proteins.
  • Design and optimize recombinant protein expression, refolding and purification methodology of human TGF-beta cytokines and receptors in microbial cells.
  • Developed deglycosylation procedure for a human growth factor and isolated highly pure deglycosylated protein that was subsequently crystallized.
  • Managed outsourcing to improve productivity .Conducted protein characterization assays.
  • Led a team's activities on a platform program for intracellular "undruggable" targets and protein-protein interactions (PPI).

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802 Protein Jobs

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7. FDA
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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.
  • Ensured compliance with appropriate WW and FDA Regulatory requirements, as well as OCD and J&J Quality System 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.
  • Designed and directed projects studying stability of drug substance and product to answer questions from FDA.
  • 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.
  • Maintained current awareness of relevant FDA and other governmental rules and guidance.
  • Participated in fill finish of FDA 510(k) submission preparation.
  • Prepare reports, memo's and technical justification for FDA submissions.
  • Prepared reports for FDA submissions and participated in answering FDA queries.
  • Applied ANSI, IES, FDA, UL standards and regulations inside R&D process and product performance.
  • Communicated directly with FDA and European auditors/inspectors on Sterility Testing, Method Validation (IQ/OQ/PQ), and Microbial Identification.
  • Evaluated performance on portable nitric oxide gas delivery devices and produced reports for FDA submission.
  • Team lead for a FLIPR Study to support European FDA Filing of Lyrica.
  • Attended FDA meetings and pre-approval inspections.

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234 FDA Jobs

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8. New Product Development
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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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30 New Product Development Jobs

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9. Cros
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high Demand
Here's how Cros is used in Principal Scientist jobs:
  • Strengthened stakeholder communications across geographic and cultural boundaries, between DTRA and National partners to enhance program effectiveness and results.
  • Project involved frequent cross-discipline meetings, development of final-product criteria, evaluation and beta-testing of software.
  • Worked with key stakeholders and cultivate cross-departmental relationship in blood glucose monitoring systems.
  • Co-developed Kraft's technical career framework and mentored junior scientists across disciplines.
  • Cross sector collaboration and identifying new synergies.
  • Participate on cross-functional development teams.
  • Presented project reviews, updates, and future plans of the team to the management and other cross functional teams.
  • Monitored progress using Excel and Microsoft Project.
  • Led and managed cross-functional teams.
  • Participated SMU development of Functionally Graded Materials for erosion resistive crossover tool.
  • Project and Technical cross functional leader for multiple next generation cardiovascular stent projects managing an annual budget of > $2.5M.
  • Research, plan and execute special projects with Microsoft Access to transfer testing applications from one Cordis site to another.
  • Staff Scientist (05/01 - 06/04) Lead a cross disciplinary team of 8 technologists to develop a diagnostic instrument.
  • Managed external collaborations with key opinion leaders, academic institutions and CROs in the US and Asia.
  • Monitored ADME studies performed at Contract Research Organizations (CROs) including on-site inspections of critical phases.
  • Established collaboration with external CROs for biological evaluation of the novel and new compounds.
  • Developed various cross-linkable coating formulations to improve the OPC lifetime by 50 times.
  • Led multidisciplinary cross-functional pharma teams that consistently accomplished goals at the specified timelines.
  • Managed regulated bioanalytical activities performed in CROs.
  • Coordinated outsourcing activities with CROs for all internal projects that required genome wide transcriptomics support (microarray analysis and RNAseq).

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139 Cros Jobs

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10. Small Molecules
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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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206 Small Molecules Jobs

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11. API
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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.
  • Capitalized on engineering background to lead project planning for various collaborations between government, academia and industry.
  • Performed rapid and complete structure confirmation of reference standards.
  • Involved in the technology transfer of the API to BMS-Ireland including LTSS campaign, validation batches, and commercial production.
  • Support budget management, control and maintain inventories, create capital appropriation projects and purchase requisition reports and invoices.
  • Utilized careful scientific rigor to rapidly come to strategic decisions, which were used to smoothly influence cross-functional teams.
  • Utilized EDAC coupling with/without catalyst for the formation of amide bond in the API step.
  • Delivered 1.5 g of deuterium labeled API in 7 days saving the company 50K.
  • syringe factory by rapid solution of resin problem/development of statistical incoming inspection of pellets by factory labs.
  • Developed biomarker assays in parallel enabling rapid establishment of several assays simultaneously with limited resources.
  • Structure-based design and parallel synthesis were combined to rapidly converge on a preclinical compound.3a, b
  • Developed and qualified capillary electrophoresis method for Heparin IVD.
  • Executed the development and validation of analytical methods for multiple API impurities to comply with ICH Q3B guidance.
  • Delivered IND Tox and FIH batches by using the first synthesis in a rapid synthesis Kilo lab.
  • Devised stability studies including accelerated studies using Ahrenius kinetics for various active pharmaceutical ingredients (APIs) and formulation components.
  • Performed physicochemical characterization, forced degradation study and biopharmaceutical assessment of API to facilitate candidate selection for development.
  • Developed techniques for fabricating and rapidly prototyping novel microfluidic chips in thermoplastics using laser-micromachining and hot-embossing.
  • Invented and developed of GeneTrapperTM cDNA Positive Selection System for rapid isolation of specific genes and gene family from cDNA libraries.
  • Served as certified analytical batch record reviewer and released over 50 batches of APIs for clinical use.
  • Developed crystallization conditions to enhance enetiomeric excess of API and avoiding chiral chromatography (US 2013/0109689 A1).

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56 API Jobs

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12. IND
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high Demand
Here's how IND is used in Principal Scientist jobs:
  • 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.
  • Collaborated with lead optimization teams as independent medicinal chemists, with a specialty in automation.
  • Support IND development activities for next generation product candidates.
  • Provided analysis and data interpretation of air and surface samples for fungi and laboratory reports of findings.
  • Assisted senior management in developing future service offerings in the area of indoor air quality.
  • Created new projects aimed in the synthesis of industrial chemicals from renewable sources.
  • Prepare reports on research findings and user-friendly fact sheets.
  • Managed in-country team of 20 individuals.
  • Produced visualization projects for General Atomics, U.S. Air Force and other industries including medical research and non-profit organizations.
  • Received Individual Performance Award for leading, preparing and delivering a Global Departmental Process Chemistry Course in Biocatalysis.
  • Worked closely with Discovery Research to apply industry leading technologies for the advancement of the Oncobiologics bi-specific platform.
  • Worked on the development of both laser based and diffuse reflectance based optical analysis instruments for industrial applications.
  • Reviewed and prepared 404 permit preconstruction notifications for wind energy sites.
  • Demonstrated that modulating the function of CDK2 can be achieved through interfering with its binding to cyclin A..
  • Designed, installed, and commissioned 1500MT defoamer plant in India.
  • Support multi-media environmental audits of oil and gas industry clients.
  • Contributed new ideas to solve the feasibility of a homogeneous immunosuppressant Sirolimus assay using binding proteins.
  • Develop new techniques for indentifying, characterizing and quantifying antigens and adjuvants.
  • Created, developed various of new cosmetic concepts by transferring cutting-edge technologies from other industries.

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273 IND Jobs

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13. Clinical Trials
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high Demand
Here's how Clinical Trials is used in Principal Scientist jobs:
  • Designed and led the project aimed at development of bio-tracers for non-invasive monitoring of pathological process in clinical trials and diagnostics.
  • 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.
  • 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.
  • 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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139 Clinical Trials Jobs

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14. Oncology
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high 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.
  • Supervised generation of soluble Flt/KDR-Fc receptor and sFLT01 protein for oncology program.
  • 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 a high-priority oncology Mab project by providing key POC immune response data in non-human primate.
  • Conducted extensive hands-on analytical and preformulation characterization in support of Oncology, Virology, and Inflammation NCEs and drug products.
  • 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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312 Oncology Jobs

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15. Drug Product
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average Demand
Here's how Drug Product is used in Principal Scientist jobs:
  • Managed drug product development projects: planned, tracked, monitored, recorded and coordinated product development and manufacturing activities.
  • Developed drug product specifications by statistical analysis of product stability data using SAS.
  • Prepared stability protocols and performed stability testing for drug product and drug substance.
  • Developed and validated stability-indicating HPLC methods for drug substance and drug product.
  • Characterize degradation products of drug products.
  • Set appropriate drug product specification.
  • Worked with Regulatory, Clinical, and Drug Product experts to evaluate the probability of success of ideas generated.
  • Provided technical supervision and training to a team of drug product developers.
  • Served as a resource and expert in drug product delivery.
  • Proposed and updated drug product shelf-life.
  • 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.
  • Well-equipped in Quality by Design (Qbd) mode Drug Product Development Process from End to End.
  • Supported scale-up drug product for release testing and investigational batch for Process Robustness at GMS site.
  • Identify and characterize impurities and degradants in API and Drug Products with ION TRAP LC/MS.
  • Tracked metrics for on-time performance of excipient, packaging and drug product releases.
  • Identify and quantitate trace-level of impurities in drug substances and drug products.
  • Reviewed drug product and drug substance analytical data packages for IND filing.
  • Used PK data for drug product in vivo performance feedback.

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178 Drug Product Jobs

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16. GLP
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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.
  • Provide scientific inputs to the development teams by contributing to contracted GLP toxicology studies.
  • Instituted Standard Operating Procedures for Quality Control (non-GLP) for liquid handling devices.
  • 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.
  • Conducted and directed GLP studies in environmental chemistry.
  • Hired and managed GLP Study Directors.
  • 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.
  • Initiated the histology/image core laboratory and established and executed SOPs of IHC, ICC, and FISH under GLP.
  • 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.
  • Validated and analyzed compounds in biological matrices to support discovery, toxicokinetic, and clinical studies under cGLP guidelines.
  • Discovered a novel and proprietary lead series of small molecule inhibitors on glucagon-like peptide 1 (GLP-1).
  • Manage the external CROs for GLP Bioanalytical studies.

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94 GLP Jobs

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17. Hplc
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average Demand
Here's how Hplc is used in Principal Scientist jobs:
  • 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.
  • Developed new HPLC test analysis methods for diagnostic products.
  • Introduced microwave-assisted synthesis, automatic silica gel purification, and prep HPLC instrumentation thatresulted in increase productivity.
  • Provided advance technical support to new products, service introductions, and troubleshooting analytical HPLC methodologies.
  • 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.
  • Optimized an HPLC/MS method to monitor enzymatic inhibitors of PCSK9 cis-cleavage and provide information critical for SAR.
  • 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.
  • Developed TLC, GC and HPLC analytical methods to determine assay and impurities.
  • Lead HPLC scientist, in the validation of stability indicating methods under cGMP.
  • Devoloped methods and SOP's for HPLC/MS analysis of biological compounds.
  • Develop HPLC methods to purify lipid ligand conjugates.
  • Reviewed Analytical studies: immunoassays (ELISA, western blot) and HPLC.
  • Experienced in analytical techniques which includes Preparative and Analytical HPLC, NMR, FT-IR, LC-MS, LC-MS/MS, UV-Vis.
  • Perform de-formulation studies for parenteral and topical dosage-forms (Liquids & semisolids) using GC-FID/ECD; UPLC/HPLC-RID/ELSD and other gravimetric procedures.

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107 Hplc Jobs

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18. Data Analysis
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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).
  • Performed data analysis workflow and statistics analysis of High Content Screening (HCS) experiments.

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489 Data Analysis Jobs

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19. Project Management
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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.
  • Project management - Biology team leadership of several discovery projects.
  • Used project management and planning proficiency regarding scientific research programs.
  • 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.
  • Lead cross-disciplinary CMC functions and teams consisting of analytical, regulatory, project management and quality.
  • 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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148 Project Management Jobs

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20. CMC
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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 technical reports and CMC section compilations for various types of regulatory submissions.
  • Prepared CMC documentation for global regulatory submissions and responses to health agency inquiries.
  • 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.
  • Lead a CMC team and progressed the development project from candidate selection to phase II clinical trial.
  • Prepared appropriate documents for client's filing of CMC sections of NDA and ANDA.
  • Provided support for timely completion of CMC section of NDA for product submission.
  • 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.
  • 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.
  • Managed CMC project activities and timelines.
  • Co-managed continuous improvement of a commercial manufacturing process and ensured regulatory documents including DMFs and IMPDs represented a consistent CMC strategy.
  • Served as the primary CMC contact to health authorities to facilitate the submission and assessment of INDs/CTAs, and a NDA.

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103 CMC Jobs

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21. Research Projects
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average 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.
  • Participated in various cross-functional teams, contributed insights and provided peptide/protein chemistry leadership support to 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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278 Research Projects Jobs

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22. Intellectual Property
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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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11 Intellectual Property Jobs

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23. GMP
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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.
  • Manage various Release and Stability programs for Pilot/Engineering and GMP lots for clinical trials.
  • Coordinate technology transfer from lab scale to GMP pilot plant for API productions.
  • Performed immune cell isolation, expansion and activation (in GMP environment).
  • Developed good manufacturing practices (GMP) compliant change control procedures.
  • Supervised and coordinated technology transfer by working in close association with manufacturing and QC/QA personnel under cGMP regulations.
  • Accomplished optimization of in-house scale up process, technology transfer to CRO for cGMP manufacture in 2.5 months.
  • Provide microbiological training, hygienic manufacturing support and cGMP guidance to R&D and manufacturing sites.
  • 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.
  • Support Quality Assurance to maintain and ensure high quality of documents in compliance with cGMP.
  • Lead QC and validation science of stability indicating methods under cGMP.
  • Reviewed batch process records and monitored the cGMP manufacturing on-site.
  • Delivered phase appropriate GMP quality API in a timely manner.
  • Developed and taught cGMP training courses.
  • level associates under GMP conditions.
  • Process demonstrated on 2 kg scale (four steps under cGMP).
  • Redefined the process and delivered the GMP API with the desired quality and solid state form within the timeline.
  • Develop and implement contingency plans to address technical challenges while adhering to aggressive project timelines and cGMP compliance guidelines.

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282 GMP Jobs

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24. Assay Development
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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.
  • Led a custom GPCR assay development group that built over 30 stable cell lines for clients.
  • 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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183 Assay Development Jobs

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25. Ndas
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average Demand
Here's how Ndas is used in Principal Scientist jobs:
  • Coauthored relevant CMC sections of regulatory filings including ANDAs and deficiency/comment letter responses.
  • Represented the company as an expert witness (depositions) during lawsuits for various filed ANDAs.
  • Authored Regulatory Documents directly supporting Investigative New Drugs (INDs) and New Drug Applications (NDAs).

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3 Ndas Jobs

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26. QC
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average Demand
Here's how QC is used in Principal Scientist jobs:
  • Created/Modified Standard Operating Procedures, Detailed Manufacturing Instructions, In-Process and Final QC testing instructions, and Validation documents.
  • 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.
  • Conducted Analytical Technical Services and QC Laboratories instrumentation scientific investigations.
  • 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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392 QC Jobs

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27. Pk/Pd
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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.
  • Delivered a lecture regarding Advanced Pharmacokinetics and population PK/PD analysis to the University of Washington graduate students (Jun 2014).
  • Supported AMG 900, a pan-aurora kinase inhibitor for solid tumors, clinical development by providing expertise in PK/PD.
  • Identified CROs and managed CRO work for hit screening and PK/PD study.

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28. Technical Support
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average Demand
Here's how Technical Support is used in Principal Scientist jobs:
  • Served as individual contributor as well as provided technical support for research and manufacturing activities of global organization.
  • 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.
  • Provided CLIA (Clinical Laboratory Improvement Amendments) technical support.
  • Maintain client relationship by providing technical support to projects.
  • Provided technical support for periodical updates of transcript sets.
  • Provided technical support and troubleshooting for the key technologies.
  • 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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91 Technical Support Jobs

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29. DNA
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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.
  • Established and managed outside contracts and budgets for DNA and protein-related support services.
  • Identified critical DNA sequence in the promoter that served as a target.
  • Performed PCR based assays and DNA Synthesis to manufacture in-process testing reagents.
  • 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.
  • 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.
  • Optimized lyophilization of asDNA parenteral formulations, and oral formulations Manufactured linkers used to attach synthetic antisense DNA to proteins.

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336 DNA Jobs

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30. Business Development
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low 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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37 Business Development Jobs

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31. Drug Candidates
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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.
  • Studied cellular activity of related peptide drug candidates to better understand the mechanism of action.
  • Research results have moved company's tumor drug candidates through research and pre-clinical development stage.
  • 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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212 Drug Candidates Jobs

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32. DOE
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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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122 DOE Jobs

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33. New Technologies
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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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55 New Technologies Jobs

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34. Clinical Development
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low Demand
Here's how Clinical Development is used in Principal Scientist jobs:
  • Identify and interact with clinical opinion leaders on a regular basis to shape clinical development strategy.
  • Established rapport and trust in clinical development community, resulting in substantial repeat and referral business.
  • Contributed to the data package for two inflammation compounds that advanced into clinical development.
  • Progressed target program from idea conceptualization through early clinical development.
  • Contributed to scale-up work of a key intermediate to support the advancement of a DPP4 inhibitor into clinical development.
  • Participated in the chemical process campaign to deliver kilograms of EDP-420 for clinical development.
  • Led drug development projects from target ID and validation to clinical development.
  • Played an integral part in bringing four programs into clinical development.
  • Worked on global teams for clinical development of vaccine products.
  • Ensured timely transition of therapeutic antibody candidates to preclinical and clinical development in collaboration with internal R&D departmental teams.
  • Contributed to the preclinical development of a novel anti-diabetic agent by running IND-enabling pharmacology activities and writing IND-related documents.
  • Developed integrated nonclinical development plans and discussion with FDA at face-to-face pre-IND meetings.
  • Contributed to the advancement of a GPR119 agonist into clinical development.
  • Advanced CCR1 antagonist, PS031291, into preclinical development.
  • Worked closely with a clinical development team to support the development of anti-amyloid therapy for a treatment of age-related macular degeneration.
  • Advanced three compounds from discovery to preclinical development on an aggressive timeline.

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449 Clinical Development Jobs

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35. Formulation Development
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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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176 Formulation Development Jobs

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36. Sbir
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low Demand
Here's how Sbir is used in Principal Scientist jobs:
  • Developed custom embedded software for specialized military SBIR programs: Non-lethal strobe light to defeat laser-targeted, surface-to-air missiles.
  • Awarded SBIR grant from the NIH as the Principal Investigator to develop RNA integrity assay for archival FFPE cancer tissue samples.
  • Initiated and participated in writing 12 SBIR proposals of which 5 were awarded (42% award rate).
  • 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.
  • Obtained and managed more than $2.5M in SBIR funding.
  • Received SBIR and NASA Supplier Awards.
  • Awarded multiple research grants towards RSI micro-machining efforts from the SBIR/STTR program with AFRL, ONR, NIST, & NASA.

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37. Technical Reports
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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.
  • Supervised coordinated, reviewed results and prepared technical reports for the qualifications.
  • Coordinate and lead field investigations, analyzed data and compiled technical reports.
  • Write technical reports, participate in preparing Regulatory Documents.
  • Published 28 Eastman Chemical Company internal technical reports.
  • Prepare technical reports, publications and oral presentations.
  • Assist in technical review of batch records for lot release, draft scientific and technical reports.
  • Review all data and technical reports and make recommendations on next steps and follow up studies.
  • Lead technical writer for new funding proposals, technical reports, and corporate marketing/messaging efforts.
  • Prepare technical reports, SOP s, IACUC and IBC applications, and scientific papers.
  • 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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48 Technical Reports Jobs

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38. Raw Materials
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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.
  • Provided hazardous assessment on raw materials and process condition prior to and during manufacturing.
  • Developed supply strategies for raw materials and downstream intermediates used globally by Chemical Development.
  • 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
  • Developed, revised, and updated NIR identity models for APIs and incoming raw materials.
  • Generated raw materials and developed immunoassays for several renal biomarkers.

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197 Raw Materials Jobs

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39. Drug Substance
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low Demand
Here's how Drug Substance is used in Principal Scientist jobs:
  • Supported drug product formulation and drug substance process development through timely development and execution of methods and testing.
  • Applied QbD principles to develop control strategies for a late-state drug substance processes.
  • Managed $5 million budget for drug substance supply (development only).
  • Lead team determining process and degradation impurities in drug substance and product.
  • Managed phys-chemical characterization group for drug substance process support for 1.5 years.
  • Instructed chemists to perform characterization of drug substance and excipient by using wet chemistry and solid state analysis.
  • Core member of drug substance analytics team, project review team and paperless laboratory project team.
  • Managed the method verification of assay related compounds for drug substance and excipients !
  • Applied the same technology for the transdermal delivery of drug substances.

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99 Drug Substance Jobs

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40. Clinical Studies
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low Demand
Here's how Clinical Studies is used in Principal Scientist jobs:
  • Functioned as Sub-Investigator on two Phase II clinical studies under an IND.
  • Conducted research and analyzed data to identify potential biomarkers and provide input for selection of candidates for non-clinical studies development.
  • Designed and performed pre-formulation and formulation screenings for clinical studies in a matrix team environment.
  • Developed and validated biomarker assays for clinical studies using Gyros technology.
  • Provided bioanalytical support for non-clinical studies, phase 1, 2 and 3 clinical trials, as well as post-marketing support.
  • Developed and qualified ELISA and cell-based assays for the safety assessment of neutralizing antibodies in preclinical studies.
  • Prioritize preclinical studies for lead and back-up compounds per drug screening cascade including safety pharmacology studies.
  • Conducted histology and micro-CT for the assessment of tissue regeneration in pre-clinical studies.
  • Performed interviews and evaluation and oversight of CROs for nonclinical studies.
  • Developed DMPK strategies to appropriately time non-clinical studies (e.g.
  • Scaled up 5-HT4 backup compound for preclinical studies.
  • Developed NMR-based metabonomics for potential biomarker identification in clinical studies.
  • Led preclinical studies needed for entry into phase I clinical development including ADME, pharmacokinetics, and pharmacodynamics.
  • Delivered purified synthetic peptides, recombinant therapeutic proteins, and mAbs to support preclinical studies.

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224 Clinical Studies Jobs

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41. SAR
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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.
  • Maintain team site calendar and update as necessary * Manage SSRS request system and open communication with LAS for study scheduling.
  • Designed and implemented chemistry plans to drive SAR, improving potency and selectivity in combination with optimizing DMPK and ADME properties.
  • Learned various aspects of drug discovery processes; gained valuable medicinal chemistry skills and SAR analysis capabilities.
  • 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.
  • Led isolation of highly pure proteins for further crystallization to drive SAR.
  • 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.
  • 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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10 SAR Jobs

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42. Dmpk
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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.
  • Represented DMPK group in multidisciplinary project program to provide guidance and resolution for PK issues.
  • 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.
  • Managed out-sourcing of DMPK activities prior to establishment of in-house capabilities.
  • Solved major DMPK challenges for this series of compounds.
  • Served as DMPK program representative on an antimicrobial program.
  • Scheduled and managed DMPK tests and analyzed data.
  • 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.
  • Strategized and managed the PK/PD program with internal collaborations including chemistry, DMPK, formulation and toxicology.
  • Performed QC and presented stability and DMPK data from parenteral biologics, to senior managers.

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43. PCR
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low Demand
Here's how PCR is used in Principal Scientist jobs:
  • Identified activators of an orphan GPCR and led compound development resulting in a collaboration with a large pharmaceutical partner.
  • Invented of PCR enhancer for amplification of GC-rich DNA molecules and sequencing high GC template DNA.
  • Identified potent proprietary lead from HTS hits for a GPCR target for diabetes.
  • Used machine learning to improve quality of multiplex PCR.
  • Conceived and developed a highly robust and automated web tool for in-silico PCR specificity analysis with advanced proprietary sequence analysis algorithms.
  • Established and optimized qPCR assays for quantitative identification of bacterial strains.
  • 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.
  • 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.
  • Developed various Long Range PCR products for sequencing on Oxford Nanopore MinION.
  • Worked with biologics group to develop activating antibodies for a GPCR target.
  • Used Hadoop to build pipeline for large-scale design of PCR primers.
  • Evaluated the ability of a genomic signature from DrugMatrix to predict hepatotoxicity by building models on RT-PCR profiles of ~200 compounds.
  • Performed mRNA quantification assays, including qRT-PCR and the branched DNA assay.
  • Funded targets included the GPCR's neurotensin and alpha adrenoceptors.
  • Generated homology models of GPCRs.
  • Developed and implemented multiplex PCR methods for rapid detection of Aflatoxigenic fungi, E. coli O157H7, Salmonella and Listeria species.
  • Project support on Protein Kinase, metallo-enzymes, Epigenetic and GPCR targets.

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169 PCR Jobs

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44. Elisa
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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.
  • Established ADC characterization including Chromeleon HPLC (SEC and HIC), ELISA, SPR, and MS.
  • 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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151 Elisa Jobs

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45. Pfizer
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low Demand
Here's how Pfizer is used in Principal Scientist jobs:
  • Designed, developed and executed a business strategy for the communication team aligned with Pfizer business goals.
  • Followed by examining the relationship of promiscuity measure to toxicity using a Pfizer proprietary compound set.
  • Collaborated with FDA scientists as part of a Pfizer/FDA CRADA to develop chemical imaging for PAT.
  • Nominated for 2014 Great Manager Award, which represents the top 10% of Pfizer managers.
  • Led Communication Team, Hispanic-Latino Colleague Resources Group (CRG) at Pfizer.
  • 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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98 Pfizer Jobs

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46. HTS
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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.
  • 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.
  • 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.
  • Managed and chaired HTS cell-based assay development and screening production teams.
  • Developed robotic methods for compound screening (HTS).
  • 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.
  • 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.
  • Lead a group of 8 scientists and contractor technicians in the ultra-high throughput screening (uHTS) laboratory.
  • Job Description: I worked in the Consumer Technical Insights group supporting North American Spreads & Dressings.
  • Analyzed HTS data for false positives and false negatives, new scaffolds, and SAR.
  • Identified new Latam consumer's insights that influence key drivers of likes and dislikes.
  • Key member of Continuous Process Improve Team to optimize HTS hits triaging process.
  • Developed high responsive HTS cellular assays using flow cytometric cell sorting and cloning.
  • Flow Cytometry & Image (Cellomics) Analysis HTS applications development group leader.

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15 HTS Jobs

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47. QA
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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.
  • Collaborate with Discovery, CMC, Regulatory, QA and contribute in multiple Nonclinical and Clinical project teams.
  • 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.
  • Managed the company's environmental QA work with a staff of four personnel.
  • 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.
  • Provided appropriate service on the development and improvement of analytical methodology and leading analytical investigations in the QC/QA department.
  • Assist in new distributor plant startup and implement Honeywell QA standards in distributor's analytical facilities.
  • Design and develop QA/QC procedures and standards for new Solstice yf refrigerant products.
  • Developed numerous UFP-QAPPs in a timely manner.
  • Implemented QA/QC, compliances, licenses, SOPs for 30Ksqft AAALAC facilities.

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6 QA Jobs

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48. ICH
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low Demand
Here's how ICH is used in Principal Scientist jobs:
  • Involved in many respiratory programs which led to clinical recommendation of several compounds.
  • Established in-house capabilities to support commercial activity in oxygen enrichment.
  • Engineered yeast strains to produce lactic acid at low pH, which were successfully implemented at commercial scale.
  • Sole developer of CRISPR genome browser, a tool which will help customers to visualize genome editing process.
  • Directed the optimization of library construction and target enrichment steps in order to reduce costs.
  • Identified and pulled in-house multiple opportunities which fed and supported the technology pipeline.
  • Led two IND-enabling teams, one of which successfully reached clinical trials.
  • Engaged colleagues for transfer of materials and protocols from Sandwich.
  • Employed a workflow in which several chemists prepared building blocks that were passed to a point man for final assembly.
  • Initiated and built the Euripred consortium, which has subsequently been funded by the EC after I left NIBSC.
  • Led four research program teams, one of which nominated a development candidate which successfully reached clinical trials.
  • Directed preparation of twenty isoflavone scaffolds, from which 30 targets were delivered.
  • Home: 908-686-5402 richwbond@gmail.com Cell: 908-468-1324
  • Project leader for the Cannabinoid Receptor 1 Inverse Agonist program which also advanced into early development.
  • Developed Power Stay platform technology across the brand product line which was successfully launched in 2014.
  • Developed technologies which, today, support well over $ 4 bn.
  • Developed Comfort platform technology which was successfully launched in 2015.
  • Designed assays for identification of molecular mechanisms by which ALDH2 activators protect cell proliferation in the presence of toxic aldehydes 3.
  • Led the development of an NGS ampli-seq assay for the detection of deletions on mitochondrial DNA which use breakpoint as targets.
  • Conducted in-vivo and in-vitro degradation study for biodegradable stents, which was a potentially breakthrough approach to vascular stent.

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42 ICH Jobs

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49. Animal Models
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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.
  • Skilled in multiple dosing/bleeding techniques with multiple animal models mouse, rat, rabbit, dog, marmoset monkey.
  • Designed and synthesized novel, potent compounds that showed excellent physical properties and favorable PK properties in animal models.
  • Skilled in multiple tissue collection sites in multiple animal models.
  • Carried out standard molecular biology techniques for making plasmid constructs, processed frozen animal tissues and utilized animal models in studies.
  • 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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277 Animal Models Jobs

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50. Patent Applications
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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.

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131 Patent Applications Jobs

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Principal Scientist Jobs

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20 Most Common Skills For A Principal Scientist

Analytical Methods

13.3%

Regulatory Submissions

8.6%

Drug Discovery

8.3%

R

7.4%

Medicinal Chemistry

7.0%

Protein

5.4%

FDA

5.3%

New Product Development

5.2%

Cros

5.2%

Small Molecules

4.0%

API

3.8%

IND

3.4%

Clinical Trials

3.4%

Oncology

3.2%

Drug Product

3.0%

GLP

2.8%

Hplc

2.8%

Data Analysis

2.8%

Project Management

2.6%

CMC

2.5%
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Typical Skill-Sets Required For A Principal Scientist

Rank Skill
1 Analytical Methods 9.0%
2 Regulatory Submissions 5.8%
3 Drug Discovery 5.6%
4 R 5.0%
5 Medicinal Chemistry 4.7%
6 Protein 3.6%
7 FDA 3.6%
8 New Product Development 3.5%
9 Cros 3.5%
10 Small Molecules 2.7%
11 API 2.6%
12 IND 2.3%
13 Clinical Trials 2.3%
14 Oncology 2.1%
15 Drug Product 2.0%
16 GLP 1.9%
17 Hplc 1.9%
18 Data Analysis 1.9%
19 Project Management 1.7%
20 CMC 1.7%
21 Research Projects 1.7%
22 Intellectual Property 1.7%
23 GMP 1.6%
24 Assay Development 1.5%
25 Ndas 1.4%
26 QC 1.3%
27 Pk/Pd 1.3%
28 Technical Support 1.2%
29 DNA 1.1%
30 Business Development 1.1%
31 Drug Candidates 1.1%
32 DOE 1.1%
33 New Technologies 1.0%
34 Clinical Development 1.0%
35 Formulation Development 1.0%
36 Sbir 1.0%
37 Technical Reports 1.0%
38 Raw Materials 1.0%
39 Drug Substance 1.0%
40 Clinical Studies 0.9%
41 SAR 0.9%
42 Dmpk 0.9%
43 PCR 0.9%
44 Elisa 0.9%
45 Pfizer 0.9%
46 HTS 0.9%
47 QA 0.8%
48 ICH 0.8%
49 Animal Models 0.8%
50 Patent Applications 0.8%
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15,242 Principal Scientist Jobs

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