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0-5 years of experience
- Planned and led the efforts on next-generation drug-eluting anticancer embolization device development.
- Solved the long-term product scale-up problem in embolization product manufacturing in 3 months to dramatically expedite FDA regulatory submission.
- Developed new processes and formulations for materials and medical device manufacturing that could save production cost and time by more than 75%.
- Led the efforts on improving drug release from biodegradable medical device through polymer modification.
0-5 years of experience
- Developed automated method for reproducible emulsion PCR process that was implemented in final system configuration.
- Provided bug reports and design suggestions to engineering team, during testing of development builds of GeneRead QIAcube hardware and software, resulting in release of production version of system.
- Directed group of 2-4 scientists and research associates in matrix setting, developing beads QC methods and intermediate products, improving clonal amplification pipeline for upcoming system release.
- Managed 2 direct reports, preparing and submitting research technical reports, presenting data in meetings.
- Served as part of subsystem decision meeting overseeing clonal amplification pipeline development, managing subsystem configuration until Gene Reader system was released into production.
0-5 years of experience
- Performed DOE to identify process limits through flame modeling of laser pyrolysis for the achievable nanoparticles BET surface area, XRD crystal size, and achieved 4% increase in production yield.
- Identified material aging and degradation dependence through numerical data analysis, and improved material durability by more than 2 months.
- Performed DOE with JMP through hands-on characterization to design and model material screen printing properties to reduce actual screen printing efforts.
6-10 years of experience
Responsible for development and execution of a variety of cell based and enzyme assays to support the programs from target validation to PCC
- Developed and optimized cell based assays to support small molecule screening for diabetes, obesity, hypertension, and neurological disease targets
- Independently analyzed and communicated data to Program teams via written reports and oral presentations.
- Established GPCR filtration binding assays for orthosteric and allosteric radioligands. Performed mutagenesis to identify key residues critical for allosteric antagonist binding to guide SAR and support crystallization efforts.
- Developed allosteric cell-based shift assays to quantify properties (alpha/ beta/tau) of allosteric modulators for GPCR targets
- Developed a cell-based bioassay to enable quantification of functional plasma peptide levels to support dose selection for in vivo studies
- Utilized label-free assays (i.e. EPIC) to understand differences in cellular responses in recombinant versus physiologically relevant cells
- Compared target expression in 2D versus 3D cultures using primary cardiac fibroblasts
- Developed a glucose uptake assay in primary adipocytes to support diabetes program. Decreased assay turnaround time from weeks to days by utilizing frozen adipocytes.
6-10 years of experience
Developed new testing methods and improved existing methods for raw materials. Supervised the training of co-workers on instruments and methods.
- Reviewed and approved Raw Materials, Oligonucleotides and Finished Products for release and stability.
- Wrote and revised Specifications and Standard Operating Procedures for new and existing products.
- Supervised the training of new co-workers and existing co-workers on new and existing instruments/methods.
- Evaluated and approved the laboratory test results of four co-workers.
- Reviewed and developed new testing methodologies for new and existing chemical raw materials to ensure quality using the GC, DSC UV-Vis, FT-IR, Coulter Multisizer, Refractometer, Polarimeter, Karl Fischer, and AA.
- Followed cGMP, GLP, in-house safety regulations, and OSHA guidelines and regulations.
- Handled complaints and requests for products from other departments.
10+ years of experience
- Coordinator of specimens: consented volunteers, worked with medical to submit changes to IRB, resolved discrepancies or deviations from protocol related to specimen collection, audited clinical site records for joint study with R&D.
- Coordinated, acquired, managed, tracked, and screened biological samples to improve efficiency of sample use for research and development activities, as well as verification and validation studies.
- Experienced in writing, documenting and executing studies that conform to FDA and other regulatory bodies to meet product specifications and launch of products for sale.
- Developed, optimized, characterized, and executed verification and validation (V&V) studies for the release of molecular diagnostic tests to support US and Ex-US launches that contributed to an average 5% annual new revenue growth.
- 5S (Workplace Organization Method) Champion for 6 R&D labs to increase productivity and process efficiencies.
- Mentored junior colleagues in sample processing, microbiological techniques, and use of equipment.
0-5 years of experience
- Developed successful method for screening crystalline forms of small molecule APIs
- Responsible for applying DOE to formulation development and training other associates in using DOE software – designed and analyzed formulation experiments for polymer-based therapeutic
- Performed stability, solubility, and permeability studies on small molecule APIs using HPLC, LC-MS, UV-vis, XRPD, DSC, TGA, and Caco-2 cell monolayer assay in support of client’s project
- Developed proposals for attracting external pharmaceutical contracts and reported results to clients in teleconferences and written reports
- Supervised and trained junior associates
0-5 years of experience
Area of research: GPCR and ion channel programs
- Designed and developed a novel FLIPR based high throughput assay to characterize ion channel modulators by creatively utilizating mutliple instruments such as Echo, PlateMate, and FLIPR TETRA.
- Established and optimized Gq-IP-One, Gs-cAMP and pERK assays to profile and differentiate full and partial GPCR agonists.
- Developed and employed cAMP Schild analysis and serum shift assays to ensure smooth transfer of an anti-migraine program, and supported lead molecule characterization.
- Investigated the binding sites of MRL proprietary anti-diabetic AgoPAM/Partial/Full agonists using binding and functional assays on mutated GPCRs.
0-5 years of experience
- Led advanced process development projects of K475
- Established pre-screening inspection protocols for substrate and carrier quality control
- Developed process tuning guide for DBR uniformity optimization
- Solved oxygen contamination issue from carriers
- Designed new carrier for 7×6″ process with improved WiW thickness and PL uniformity
0-5 years of experience
Managed staffing and customer service for the LC/GC group in an ISO environment. Manage research and analytical projects to manage workload, ensure timely completion and quality work. Identify individual development needs for the analyst and worked to address them. Perform GC and LC/MS analyses including data processing and data review.
- Developed and initiated the LC/GC Huddle Board to manage workflow as a team, improve communication, and make issues / concerns more visible.
- Established a biweekly meeting for the LC/GC group to improve team dynamic.
- Initiated a training process development complete with modules, training plan, and proficiency measure.
0-5 years of experience
Antibody discovery: from protein to antibody phage panning.
- Established a new Molecular Biology Laboratory from scratch and a limited budget.
- Created over 24 new protein constructs and antibody controls. Involved in all molecular biology steps.
- Protein characterization and QC.
- Started phage display platform.
0-5 years of experience
- Lead formulations scientist, reported directly to CEO.
- Responsible for the design of in vivo/in vitro studies.
- Routinely analyzed, interpreted, and presented my groups key findings in company meetings.
- Lead process development efforts that provided company with intellectual property and patent-ability within the RNA space.
- Oversight of all formulations and implantation of strategies to improve pharmacokinetic properties of custom designed liposomal drug delivery systems
- Responsible for designing novel ionizable lipids which increased chemical stability
6-10 years of experience
Perform routine and non-routine scientific testing of drug products utilizing laboratory apparatus; generation, analyses, and recording of data; internal training of analysts, high quality validation of data generated by other analysts; the initiation, writing and review laboratory OOS/OOE investigations; SOP-QM inspection plan reviews; method and product transfers, both internal and external.
- Member of two inter-departmental process teams whose performances were routinely recognized for participating in 5S and Lean Lab initiatives by contributing to the reduction of time from customer order to delivery through process improvements and efficiencies.
- Investigation/deviation (OOS/OOE) originator in Trackwise, with responsibility of writing and/or reviewing laboratory investigations in the requisite time, while meeting daily deadlines for batch release and stability testing.
- Enabled improvement in the manufacturing process of a drug product, and eventually a successful site transfer of that product, by demonstrating the accuracy of laboratory processes.
- Partnered with Method Development and Validation group in the testing and transferring of various products and methods, achieving successful site transfers or more efficient laboratory processes.
- Coordinated with Stability department for the handling/testing of samples in order that FDA requirements would be met, using annuals stability reports to anticipates potential product concerns.
- Recognized for sharing knowledge and expertise with other analysts, and providing support off-site as needed to affiliates such as Turkey and China, and subcontractors (e.g. Wisconsin).
0-5 years of experience
- Established multiple key assays (Taqman gene expression assay, a-SMA imaging assay and pro-collagen HTRF assay) for phenotypic screening/follow up and Fibrosis/CKD platforms build up. Assays are essential for MOA studies and target identification/validation.
- Led the effort to evaluate a fibrosis GPCR target; collaborated with in vitro, in vivo pharmacology and DMPK group and reached a solid no-go decision for the target based on pharmacological POC studies.
- Established and streamlined D2O labeled collagen isolation assay as a valuable and advanced biomarker for fibrosis.
- Analyzed mRNA, protein and biochemicals from tissue samples of all fibrosis/CKD in vivo studies and provided high quality results for go/no go decisions. Established high throughput western blot assays to evaluate biomarkers and signal transduction pathways.
0-5 years of experience
- Provided timely patent portfolio maintenance instructions to Legal department
- Organized and delivered Patent Training 101 course to R&D in collaboration with Innography
- Patent landscaping for the Odor on Fabrics technology development platform
- Analyzed Sun Products OI Model, suggested improvements and created graphical visualization of OI Ecosystem
- Researched Front End Innovation (FEI) models and determined that Flexible & Scalable FEI model best represents Sun’s FEI process
- Led the cross-functional team design of new Supplier Relationship Management (SRM) model
- Strategic expansion of OI Ecosystem to Universities based on patent landscaping
0-5 years of experience
Led several drug substance process development and manufacturing projects for successful completion at CROs/CMOs.
- Headed drug substance process research and development, technology transfers, process validations and commercial manufacturing of LinzessTM (First oral dose peptide drug, Linaclotide) API at CMOs.
- Compliant with cGMP, ICH Q7A, and FDA regulations. Reviewed production and packaging batch records, provided technical input (including investigations, deviations and CAPAs) to QA for the release of manufactured goods.
- Led CMO identification, evaluation and selection, audited sites along with QA, initiated projects with US and international CMOs and maintained excellent relationships. Conducted technical audits of CMOs/packagers along with QA to ensure conformance with corporate policies and FDA regulations.
- Collaborated with QA, QC, Regulatory Affairs, Production, Finance, Legal and supply chain.
0-5 years of experience
Performed analytical testing, stability evaluation and data trending on late phase solid-dosage and inhaled drug candidates. Managed informal and formal stability protocols and led equivalency exercises.
- Authored revisions to Andersen Cascade Impaction Standard Operating Procedures (SOPs) to ensure procedures reflected current practices.
- Supported projects by providing training, coaching, and mentoring to new and current analysts on a variety of analytical methods, operation of automated testing platforms, and our processes. Assist with documenting investigations, managing testing workload, scheduling, and time management. Also, identified appropriate training opportunities for their development.
- Conducted stability evaluations, method validations, equivalency studies, and transfer activities on a variety of solid dose and inhaled projects in-between R&D project teams and Global Manufacturing and Supply sites (GMS)
- Performed data analysis and trending utilizing Statistica(TM) to facilitate data interpretation of the stability protocols and investigational studies for an Inhaled FDC Dry Powder in Capsule project that was in development; discussing data trends at project team meetings to aid in understanding and enabling project milestones to be reached.
- Provided valuable input during EMPACT exercises, which included Failure Mode Effect Analysis (FMEA), Risk Assessments, and Fish-bone diagrams to scrutinize method parameters and settings that need to be considered when developing, validating, and utilizing an automated analytical method (solid or inhaled) versus a manual techniques
- Led various work packages for a dry powder in capsule project. Wrote stability protocols, coordinated the timely set down and resources required for the stability work. Ensuring testing was completed through data review in a timely fashion. Provided Statistica(TM) data compilation and analysis and presented these at the bi-weekly project team reviews.
0-5 years of experience
Lead development of SNP variant based genomic products; worked with marketing and sales teams to define product profiles; designed experiments, performed statistical characterization of genotypic and phenotypic, data, developed databases, and performed modeling and statistical analysis. Data preparation was performed in Java, Bayesian statistical modeling was performed in Java, and commercial tools. Post processing statistical analysis was performed using R.
- Developed algorithms and created pipelines for identification of minimum number of features required to quantify successful product development through simulations. Enhance and strengthen capabilities of colleagues in using pipelines and computational biology tools. Designed and developed database to store large amounts of genotype data.
- Apply machine learning methodologies to develop validation tools that identify breed class and mixed class composition utilizing features generated from genetic profile. R, Weka programs were used. Developed parentage analysis software currently used as commercial software in house. Tweaked Weka Java packages for creative solution.
- Direct and coordinate Java pipeline development to support WGA analysis required for product development Pfizer
0-5 years of experience
- Developed numerical model of liquid-liquid Pu and U extraction at the chemical plant.
- Analyzed kinetics of chemical components in extraction and separation of Pu & U.
- Developed strategy of experimental tests for the PUREX process model and for evaluation of safe operation conditions for the plant reprocessing spent nuclear fuel and weapons-grade plutonium. Served as a liaison between Duke Energy and MIT ChemE Department.
0-5 years of experience
Developed, validated and performed immunoassay (ELISA) analytical methods on automated platforms in support of biological substances (monoclonal antibodies).
- Process mapped data capture to results compilation processes in support of Investigation/New Drug Applications (FDA reporting).
- Conducted and coordinated qualification activities for integrated plate readers.
- Project Lead for Watson
- Supported Watson
6-10 years of experience
- Served as the synthesis and design chemistry lead on multiple programs within the antibacterial, diabetes and oncology therapeutic areas covering a diverse set of biochemical targets
- Proficient in organic synthesis with extensive experience in analog route and library design
- Managed chemistry resource efficiently (up to 10 chemists across 3 lab units as well as external CRO FTEs, FFS, and PMC) assisting in the synthesis of templates and analogs (0.01 – 100+ g scales), synthetic route design/troubleshooting and analog/chemistry plan prioritization
- Coordinated and led project team and educational-based meetings, authored and provided editorial support on numerous patents and publications, and served on multiple committees
- Has a working knowledge of in silico tools used for structure-based drug design (molecular modeling), compound and SAR analysis (cheminformatics), lead generation/optimization, and library design
0-5 years of experience
- Served as the senior biological science advisor in support of a complex multidisciplinary intelligence program. Directed the planning, development and operations of Chemical and Biological intelligence programs.
- Administered contract support for CBRNE laboratories consistently within budget and schedule. Established goals, objectives and priorities and developed plans and projects to accomplish mission of the office within the scope of the CBRNE laboratory contracts. Provided guidance to ensure operations and programs were streamlined, efficient and in compliance with regulatory requirements. Identified and corrected programmatic and contractual issues.
- Developed new policies and procedures that increased the efficiency of laboratory capabilities. Increased the effectiveness of current programs, evaluated the feasibility of future programs and developed plans to meet mission objectives.
- Established substantive ties and collaborations with other government agencies, Intelligence community (IC) partners and relevant external partners.
- Assisted multiple DoD agencies by providing expert technical evaluation and review of proposed research and development projects.
- Represented division at DoD and IC committees and working groups.
0-5 years of experience
- Led the establishment and technical transfer of NGS related molecular genetic testing service
- Managed the research and development of RT-qPCR based gene expression assays with RNA isolated from formaldehyde-fixed, paraffin-embedded (FFPE) tissues
- Supported molecular manufactory group by improving the transcript production, quantification, and stability monitoring processes
- Led the pre-development and feasibility study of the rare cell isolation and detection assay for further development into a laboratory developed test (LDT), a class of IVD that is developed, validated and offered within a single laboratory
- Prototyped and optimized an automated immunoassay (“ELISA” in solution) for the detection of auto- antibodies that are critically linked to heart failure
- Developed a next-generation sequencing (NGS) assay to determine HIV tropism
0-5 years of experience
- Developed and qualified immunogenicity assays in support of a vaccine program.
- Managed teams of up to 10 people during assay validations.
- Coordinated sample analysis for a study with throughput of up to 5000 samples per week.
0-5 years of experience
- Developed and Validated stability indicating methods for Dissolution and Content/Impurities testing
- Led successful Dissolution Method Development/Validation campaign utilizing Design of Experiment and Statistical Analysis which lead to improved knowledge space and stream lined analysis requirements and time lines
- US Lead Analyst for ASM Platform (Accelerated Stability Modelling)
- Administered US ASM Equipment rollout – installation, validation, qualification
- Analytical lead for asset transfer from GSK to Novartis
- Able to balance testing, development, and documentation workload for multiple projects simultaneously
0-5 years of experience
- Develop new products, trouble-shoot and solve production issues.
- Investigate and solve “out of spec†issues between label and formula. Improve production process of existing products.
- Formulated mostly powder beverages, but also formulated and improved production process for tablets, capsules, and granulations.
- Evaluated and submitted requests for production deviations; including but not limited to process, and formula adjustments.
- Work with vendors and suppliers
0-5 years of experience
- Heavily participated in injectable generic drug ANDA filing preparation. Prepared response to FDA deficiency letter for multiple ANDA submissions.
- Worked for generic drug R&D using QbD and Design Space principles, tasks included RLD characterization, feasibility studies, characterization of API and excipient from different suppliers, QTPP defining, risk assessment, compounding procedure, dissolution profile, bioequivalence and bioavailability evaluation, sterilization, lyo cycle optimization based on DSC, FDM, and DOE, degradation pathway studies (oxidation, light, pH, freeze-thaw ), buffer capacity, API solubility-pH profile, filter selection, filter bubble point, photostability, container-closure selection, particle size, process transfer / scale-up, lab batch, engineering batch, exhibit batch manufacturing, characterization, and stability studies.
- Closely worked with Business Development staffs for new drug projects, researched potential market share, identified key challenges of R&D, evaluated in-house feasibility and potential partner, proposed development plan.
- Built up close partnership with domestic and international CMOs & CROs for various projects; Traveled to CMOs for on-site auditing, guiding and monitoring product scale up, engineering batch or exhibit batch manufacturing.
0-5 years of experience
- Conducted drug and metabolite analysis utilizing LCMSMS.
- Analytical documentation per GLP regulations.
- Performed various method validation and development studies on small and large molecule analytes.
- Served as Principal Investigator on studies, overseeing work of small teams.
- Prepared calibration and control samples from pure manufactured standards.
- Conducted peer review of analytical data.
0-5 years of experience
Act independently as a Principal Investigator in a CRO environment, conducting development and validation of ELISA and ECL (electrochemiluminescent) assays for large molecule characterization and quantification under direction of pharmaceutical and biotech sponsors
- Manage projects as Principal Investigator through development, validation, report writing, and QC/QA audits
- Oversee the work of one or more bench scientists
- Develop and validate client-specific PK, ADA, and NAb assays
- Interact directly with sponsors on multiple, simultaneous projects
- Author validation plans, methods, and validation reports
- Perform assays, antibody conjugation, and data analysis
0-5 years of experience
Evaluated Drug-target interactions and mechanism of action of a leading cancer drug candidate (PG490-88) and suggested several protein candidates that might play a role in the mechanism of action of the drug.
- Contributed to IND filing (2001) of PG 490 by establishing pro-drug to active drug conversion using Human plasma samples. I used various radio labeled cultured cells and isolated and identified label-associated proteins by using various chromatography techniques including Two dimensional SDS-PAGE, Ion exchange, hydrophobic interaction and gel filtration. Identification of specific proteins was achieved by autoradiography and by mass spectrometry.
- Anticancer drug Taxol binding site was discovered using Structure-Activity relationships. Different radio labeled Taxol photo-affinity analogs were prepared and employed. We were the first one to map the drug binding domains to identify the site of interaction of Taxol on microtubules. Various techniques including Two dimensional SDS-PAGE, Western blotting, Northern blotting and Southern blotting, In-gel digestion, protein quantitation, chromatography and mass spectrometry techniques were used to identify cancer drug binding domains.
- Developed cell lines resistance to Taxol and Vinblastine and to study multidrug resistance (MDR) and non-MDR mediated resistance.
- Identified a new alpha-tubulin isotype in cancer cell lines by using a variety of analytical techniques and LC/MS analysis. (Biochemistry 40: 2096-2103, 2001). Using this sequence, a polyclonal antibody for this new alpha tubulin isotype was developed. Antibody production was characterized with ELISA techniques. Protein concentrations were determined by standard colorimetric methods.
- Showed additional non p-glycoprotein mediated mechanisms for Taxol resistance.
6-10 years of experience
Technical advisor on issues related to oil and natural gas extraction, geologic sequestration of carbon dioxide, and best practices to reduce environmental impacts. Provides scientific expertise and analysis in support of advocacy efforts. Engages with and serves as a liaison to the scientific community, regulators, legislators, and community members.
- Led development of natural gas certification/procurement standards
- Wrote technical comments for dozens of state and federal rulemaking and permitting processes including proposed regulations for well stimulation (e.g. hydraulic fracturing), methane emissions, Underground Injection Control wells, and carbon capture and sequestration; and proposed permits for aquifer exemptions, Class II disposal wells, and Class VI geologic sequestration wells
- Wrote technical comments for numerous state and federal environmental planning documents for oil and gas development including Resource Management Plans, Environmental Assessments, Environmental Impact Statements, and Environmental Impact Assessments
- Invited expert witness at multiple California Senate hearings
- Environmental community representative to the Unconventional Resources Technology Advisory Committee, a Federal Advisory Committee to the Secretary of Energy (2013-2014)
6-10 years of experience
- Successfully developed, validated and transferred various chromatographic methods including HPLC, LC-MS-MS, uHPLC, GC and CE (CGE and iCE) in support of pharmaceutical substance/product characterization and stability testing
- Performed cGMP analytical testing (release, in-process, and stability) for protein- and oligonucleotide-based drug substances/products using various chromatographic (SEC, HILIC, HIC, RP, IEX, CGE, iCE) and bioanalytical methods (ELISA and qPCR)
- Designed and implemented method validation protocols and authored associated methods and reports in support of client’s CMC submission
- Identified OOS/OOT results, proposed/implemented testing plans for root cause investigations, and prepared investigation summaries and reports
- Reviewed testing protocols, analytical procedures, reports and a broad range of analytical data including HPLC, uHPLC, GC, CE, ELISA, qPCR, MS, UV-Vis, dissolution and Karl Fischer in support of validation, transfer, release and stability studies
- Prepared QC review statements and coordinated with laboratory staff to assure compliance with FDA/ICH guidelines, in-house SOPs and continuous improvement of laboratory processes
- Awarded “Star of the Month” in March, June and November 2014 in recognition of commitment to quality, service and teamwork
0-5 years of experience
- Developed technical plan for projects and ensure implementation of the plan.
- Managed technical and administrative aspects of the projects and supervised junior scientists and technicians.
- Generated and reviewed project reports, SOPs and protocols.
- Managed the unit for cloning and isolation of therapeutic human antibodies from human B-cells
- Managed the gene cloning core of the lab.
- Performed experiments for vaccine development
- Coordinated collaborations with external partners
- Reported to the Director.
0-5 years of experience
- Lead product development on five complex projects under multimillion dollar government contracts
- Capture product requirements and design specifications for an ophthalmic device prior to testing and submission to contract manufacturing for 510k approval
- Work with sales, QA, and software development to translate market requirements into testable product requirements for a patient satisfaction survey tool; manage resources to meet customer installation timelines and address bugs, feature requests, and updates
- Developed image processing and registration algorithms that are used in anti-counterfeiting products
- Released the QuanTEK 5900 optical inspection tool for counterfeit detection in under 2 years: Motivated the team to prototype, design, develop, and validate with 2 clients (Boeing and Honeywell)
- Led design of the next generation QuanTEK system, reducing size and cost by 50% in under 4 months for installation within a digital design manufacturing institute
- Created a laser-based spectroscopic analysis system to characterize aircraft paint degradation; Transitioned the technology from concept to benchtop to portable lab unit ready for delivery to the Air Force; Identified a new approach to improve the spectroscopic analysis system by 10 times in size, speed, and cost
- Create requirements driven milestones and tasks to guide schedule creation/estimation and monitor progress
- Coordinate design reviews with engineers and senior management to ensure completion of milestones
- Develop presentations and materials for clients, customers, and funding opportunities
0-5 years of experience
Assisting in the research and development efforts of EBDI to identify and develop new assays and technologies to be used in the future.
- Performing and designing PCR and real-time PCR assays.
- Scoring and analysis of data generated. Overseeing the technical quality of the data generated and troubleshooting problems that arise.
- Finding solutions to technical problems with assays and projects.
- Generating reports and sending them to customers while explaining the data to customers and clearing up questions they may have on the results.
- Monitoring the safety of our lab and its procedures.
- Designing and performing SNP genotyping utilizing KASP and TaqMan technologies on the Douglas Tape Array system.
- Assisting and performing SNP genotyping utilizing Golden Gate and Infinium technologies with the Illumina iScan system.
6-10 years of experience
Develop and Execute late stage in-vivo assays across multiple species to drive results across the cardiovascular and diabetes franchises
- Collaborate with internal and external partners to coordinate NHP (non-human primate) outsourcing efforts
- Analyze and present data using Excel, Word, PowerPoint, and Prism to generate reports
- Knowledge of DSI (Data Sciences International telemetry), Columbia Instruments Metabolic Rate, and German-based TSE automated systems
- Evaluate and refine repository software to capture and store data
- Execution and maintenance of 5S laboratory space methodology
- Perform general husbandry, dosing, handling, phlebotomy, and necropsy in mouse, rat, and dog
- Implant ALZET pumps in rats
0-5 years of experience
- Lead high-throughput in vitro screening group, set team goals and manage the team’s performance
- Developed multiplex immunoassays for testing immunogenicity of drug delivery systems, assays for testing cytotoxicity, EC50 determination, whole blood cytokine secretion assay for testing the safety of drug delivery systems
- Automated several protocols for high-throughput screening
- Worked closely with chemistry and formulation groups to design the new and efficient drug delivery systems and supported IND filings
0-5 years of experience
Analytical Method Development and Validation of various dosage forms (Solid, semisolid, foam, aerosols and liquid dosage forms) according to USP and FDA guidelines in a cGMP and GLP environment
- Qualitative and Quantitative Analysis of drug substances (API), raw materials, in process, finished products, and stability samples: Dissolution, Assay, Related substances assay, Residual
- Physical and Chemical Stability testing and solubility studies for preformulation Studies
- Operation, maintenance, calibration and troubleshooting of Laboratory Instruments
- Preparation and following SOPs, protocols, reports
0-5 years of experience
- Optimized a medicinal route and eliminated chromotagraphy in preparation for Tox batch/Phase I.
- Used glass reactor to perform downstream development (crystallization, impurity origin and fate, spiking and purge, volume reduction, etc.)
- Lead chemist to design and execute proven acceptable range (PAR) studies and understand critical process parameters.
- Key subject matter expert for FMEA and evaluation of risk reduction strategies.
- Ensured smooth execution of GMP production at contact manufacturing organization (CMO) by providing onsite technical support and troubleshooting for key steps.
- Lead chemist for parts of the preparation of CMC package for NDA filing.
- Mentored entry level process chemist and foster excellence throughout the department.
0-5 years of experience
- Distilled complex ideas from literature and patent sources and articulated potential solutions, addressing aspects of basic biology of drug targets, molecular pathways, and relevance disease states
- Designed, developed and executed in vitro studies to provide proof of concept for protein/small molecule targets
- Analyzed data and summaried findings/results internal presentations and reports, as needed
- Project team Subject Matter Expert (SME) – defined requirements, tested, and provided support and training for in-house DistributedBio Abgenesis software platform for DNA sequence analysis
- Developed drug discovery and develop antibody libraries for veterinary medicine; designed, developed, and optimized assays for antibody screening, identification and characterization
- Developed in situ hybridization and qPCR assays to analyze target gene expression in cells and animal tissues
- Proposed and developed in-house methodologies to identify antibody-antigen interactions by epitope mapping
- Expressed recombinant proteins in bacterial and HEK mammalian cell lines
- Prepared study documentation (protocols, analytical plans, budget and timeline guides)
0-5 years of experience
Train various GMP and R&D analytical method techniques to trainees for GMP Compliance according to client’s training systems for the Analytical Operations group
- Familiar with the following techniques under GMP guidelines; Dissolution, UPLC/HPLC, Karl Fisher, FT-IR, and TGA.
- Knowledge of various software systems including Empower 3, Thermo-Omnic, GLIMS, GxPLearn, LabX, Chemstation
- Responsible for ensuring trainees complete all training documentation and prerequisites that fulfill GMP Compliancy
- Familiar with good documentation practices including review and audit trail review of analytical data and software management systems
- Responsible for creating material for hands-on and classroom style training sessions including presentations and demonstration of various methods and techniques.
- Using OneNote and various other training metrics to manage training schedules
- Maintain laboratory and instruments in good working order
- Ensure client’s quality standards are met or exceeded and identify areas of improvement, when necessary
- Good interpersonal skills and training a variety of technical experienced staff members from beginners to expert level scientists
0-5 years of experience
Developing drugs against Age Related Diseases and discovering biomarkers and targets specific to senescent cells.
- Analyzing High Throughput Screening data and validating candidate compounds using cell viability assays.
- Analyzing data from genetic screening of shRNA libraries to discover targets.
- Preparing samples and analyzing proteomics data to discover biomarkers.
0-5 years of experience
- Responsible for owning and presenting target profiles to senior management to facilitate go/no go decisions
- Cross functional team leader for delivering proof of concept experiments in non-human primates
- [company name] and execution of high-profile intra-company programs designed to increase visibility within a highly complex organization
- Biology lead for several external collaborations including academic and industry partners
- Team lead for multiple discovery targets including identification and validation of novel assets, cross functional collaborative partner, and strategic analysis of new atherosclerosis targets
- Evaluation and due diligence assessment of external targets for Business Development and Licensing
- Merck point-person and biology lead for external collaborations with top tier academic investigators in the cardiovascular space including financial oversight over specific projects
- Merck point-person and biology lead for external institutional collaborations including external pharmaceutical companies and academic institutions
- Proposed, gained alignment, negotiated financial support and executed major internal program designed to increase research and development program visibility to internal and external collaborators
- Managed multiple associate scientists while fostering a positive environment for scientific growth and focus on high quality deliverables
0-5 years of experience
- Oversight of all Physical, Pulsed Photon luminescence, and Near Infrared laboratory testing of dietary supplements, raw materials, and chemicals
- Responsible for all instrument Calibration and continuation of program development required for sample analysis, research, and process control.
- Identifying and correcting any problems with quality testing and instrumentation
- Writing and editing Standard operating procedures and training documents in accordance with FDA cGMP and ISO 17025 requirements for laboratory competence
0-5 years of experience
- Conducting analytical testing of high complexity, including method development and/or method validation associated with the Device and Delivery Research and Development group in compliance with safety, regulatory expectations and cGMP
- Providing technical leadership to projects
- Writing analytical validation protocols and test procedures
- Initiating and conducting investigations; reviewing notebooks and reports; making recommendations for technical improvements
0-5 years of experience
- Lead manufacturing cell line development and cell line genetic characterization (CHO-DHFR)
- Lead research reagent supply
- Participate in due-diligent project review as CMC lead
- Develop protein expression technology platform
0-5 years of experience
- Evaluate and design efficient and safe synthetic routes for target Generic APIs.
- Responsible for the quality and safety of processes.
- Appropriately handle high potent (HP) compounds and controlled substances.
- Synthesize impurities/by-products as QC analytical standards.
- Prepare block flow diagram (BFD) and batch record.
- Participate in batch production of API under GMP or non-GMP condition.
- Write monthly reports.
6-10 years of experience
Involved in analysis product release and complete stability studies.
- Perform work in support Process Validating batches and method transfer.
- Perform Stability samples and testing of drug product as per the regulatory requirements.
- Involved in developing and validating methods of Assay, Content Uniformity, Impurity and Degradants, and cleaning analysis.
- Test in-process and finished products sample related substances by HPLC and UPLC instruments
0-5 years of experience
- Bioanalytical assay support for PK studies
- Clinical study data analysis and report generation
- Ligand-binding assay development (ELISA, MSD)
- Critical assay reagent formulation and characterization
0-5 years of experience
- Management of global finish system product architecture for all OEM’s and leather constructions.
- Formulation and development of new finishing systems to meet demanding OEM specifications.
- Oversight and management of the finishing and analytical testing laboratories for the validation and testing of finishing formulations and leather constructions.
- Development and execution of internal testing methods, specifications and process flows.
- Development of global best practices for finish application on leather.
- Travel globally to assist production on new technology launches, process improvements, and problem solving.
- Work with suppliers to source and develop new products, technologies, and finishing systems.
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Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
