Project Lead/ Senior Scientist Resume
Headline : A highly talented and results-driven Project Lead/ Senior Scientist with 5 years of experience in environmental health, water quality, water treatment, soil evaluation, laboratory analysis, biogeochemical pathways, and toxicity testing with significant abilities in research, biological systems, ecological principles, problem solving, leadership, analytical chemistry, statistical analysis, teamwork, and oral/written communication.
Skills : MS Office applications, SAS, Public Speaking, Leadership, Scientific Research, Technical Presentations, Laboratory Work, Wet Chemistry, Toxicity Testing, Analytical Techniques, Marketing, and Graphic Design.
- Managed R&D product testing and materials characterization laboratory and provide technical leadership in design verification, materials characterization accelerated aging and shelf-life testing for all infusion therapy products.
- Partnered with senior management in developing a long-term strategy for R&D testing laboratory and continually adapt to rapid business needs.
- Maintained department budget planning, capital equipment spending, resource planning, and oversight of testing laboratory personnel.
- Built, mentored, and coached a highly-effective team by focusing on the development and expansion of personnel skills and testing capability.
- Overhauled laboratory testing request system which improved efficiency and reduced turn-around-time from 28 to 2 days.
- Launched and executed multiple new product development projects and key programs (BD Inyste Autoguard blood control, New passive safety catheter, Nexiva Integration, Lubricant-Solvent conversion program) which contributed to increase in gross profit and sustainability of business by engaging cross-functional stakeholders Developed and implemented new method to measure temperature coefficient factor which resulted in significant time savings for multiple projects.
- Provided technical expertise and leadership for lubricant technology during FDA audits (Nogales and Sandy plants).
- Member of industry-standard group ASTM thermal measurement (Subcommittee E37) Authored pre-patent documentations and inventions that lead to two BD trade secrets and one patent.
Senior Scientist, Technical Operations Resume
Headline : Accomplished and energetic Senior Scientist with a solid history of achievement in pharmaceutical research and development. Motivated leader with strong organizational and prioritization abilities. Areas of expertise include design and development of novel pharmaceutical compounds, cGMP synthesis of radioactive and non-radioactive compounds, and cyclotron operation and maintenance.
Skills : Project Management, Product Management, Technology Development, Process Development, Next-Gen Sequencing.
- Initially joined to manage the sequencing workflow for a drug-discovery platform that utilized synthetic DNA-tags to mark potential drug candidates.
- Took on the additional responsibility for performing screenings, managing the development of our platform process and the development of a replacement technology for the drug-discovery platform.
- Designed and executed two novel library construction methods for our covalently-linked duplex molecules at the core of our screening platform (Encoded Library Technology, ELT), which increases our useful data 10-fold and eliminates convolutions introduced by conventional methods.
- Designed a multiplexing strategy for our samples that cuts annual sequencing costs by more than 75% while improving data quality.
- Established a defined and controlled sequencing workflow for the Illumina platform, while phasing out the 454 platforms, as the predominant read-out for ELT.
- Designed and executed over a dozen technology development projects pertaining to our screening platform, including process developments (automation), protocol developments (treatment and condition variables) and detection developments (sequencing), which led to increased hit ID and robustness.
- Defined and implemented their current library pooling strategy, one of the most critical steps in ELT, which decreased costs dramatically and lowered contamination levels below detection.
- Managed two independent project management teams aimed at improving the technology and our drug discovery process.
Masters of Science
Senior Scientist/ Lab Supervisor Resume
Headline : A competent and energetic Senior Scientist/ Lab Supervisor with expertise in Regulatory Affairs as well as Research and Development. Focused Regulatory Affairs specialist with great depth and breadth of experience in Biosimilar/Biopharmaceutical review and evaluation. Alongside have advanced training and hands-on experience as a Process Development Scientist on Bioprocess development, scale-up, and optimization.
Skills : Management, Maintenance, Engineering, GMP, Synthesis, Formulation.
- Developing manufacturable, stable and bioequivalent formulations for immediate and modified release oral solid dosage forms based on de-formulation and analysis of RLD (reference listed drug) Finalizing a commercial manufacturing process that is reproducible.
- Managing formulation and process development from project inception through transfer to commercial process validation.
- Develop experimental design to rapidly optimize formulation composition and processes that meet rigorous Food and Drug Administration (FDA) standards, and provide the formulation information to regulatory affairs for submitting New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) for FDA approval.
- Utilize experience and knowledge of spray granulation and Wurster coating technologies during manufacturing stages.
- Operate commonly utilized pieces of equipment for formulation development such as high shear granulators, blenders, mills, compression machines, encapsulators, tray ovens, and fluid bed drier.
- Supervise the formulation development/process development activities, scale-up and clinical batch manufacture at a CRO as needed Supervise technicians involved in projects; follow Good Manufacturing Practices (GMP), review scientific literature and stay current with formulation technologies.
- Prepare technical reports such as protocols, batch manufacturing records, and development reports for submission or Pre-Approval Inspection.
Project Manager And Senior Scientist Resume
Headline : Highly qualified Project Manager And Senior Scientist with experience in the industry. Enjoy creative problem solving and getting exposure on multiple projects, and would excel in the collaborative environment in which your company prides itself. Contribute to the company's success and growth with proper utilization of resources and implementation of the strategies, policies & norms with good logical, analytical thinking and skills along practical business line.
Skills : Research, Regulatory, Regulatory submission, Regulatory.
- Provided nutrition science leadership to help develop and support business strategies for nutrition-based product promotions and identify gaps in the marketplace to create innovative, healthy snack alternatives.
- Interfaced with members of the medical, legal, regulatory, and product teams throughout R&D, providing scientific information to assist with new product development and existing product changes.
- Recognized as a key nutritional science resource, serving as a strategic asset to consumers, healthcare professionals, and numerous internal product teams for the new line of pediatric brands.
- Conducted nutritional training sessions for the sales force, providing detailed technical information that helped the sales team better understand the nutritional value behind each product and effectively sell the new product lines.
- Worked closely with the marketing team to conduct market research to identify, evaluate, and target priority customer needs segments and assess market attractiveness and unmet customer needs.
- Demonstrated capacity to provide clinical leadership to assist various multidisciplinary divisions to capitalize on regulatory, nutrition, and health trends to effectively grow the pediatric product lines.
- Reinforced NutriPals' and PediaSure's standing as a leader in the field of pediatric nutrition by developing educational programs focused externally at parents and internally at employees and the sales force.
Master Of Science
Senior Scientist I Resume
Summary : An accomplished, results-driven senior-level scientist with over 10 years of extensive experience in Economics & Management, enterprise development, formulation and appraisal of projects, techno-economic-feasibility analysis of agro-based projects, implementation of field-based projects and evaluation, etc.
Skills : Biomaterials, Polymer Science And Engineering, Organic Synthesis/Library Synthesis, Materials Characterization
- Provides technical expertise on drug formulation, analytical and process issues within Product Development and Scientific Affairs in support of new product development of injectable drug Day-to-day operations may vary depending on the priority of the projects.
- Typical functions are designing developmental studies, executing or coordinating with the study executing group, collecting and analyzing scientific data and summarizing/writing reports for the development of injectable drug products.
- Responsible for working on formulation/process development, technology transfer, manufacture of clinical trial material, scale-up and commercialization activities for new drug products for New Drug Applications (NDAs) and generic drug products for Abbreviated New Drug Applications (ANDAs).
- Preparing or co-authoring Product Development documents for inclusion into the electronic common technical documents (eCTD) and Quality Overall Summary (QOS).
- Mentor junior level scientists and technicians in the design and execution of quality scientific experimentations to develop drug formulations.
- Coordinate with the project managers and the product development teams and provide key timeline information, present data at team and departmental technical meetings.
- Representing formulation function at cross-functional project teams.
- Providing feedback to project teams from a formulation point of view.
Masters of Business Administration
Senior Scientist - Contract Resume
Summary : Successful track record as a research bench scientist, team builder, and project leader in coordinating large and small scale projects, program implementation, and technical operations in deadline-driven situations. Industry biotechnology experience in skilled delivery of results, strategic solutions, and handling of complex R&D mission-critical engagements in the biotechnology market spaces. Unique blend of key roles as bench scientist, project manager, group leader, technical writer, public speaker, industry liaison, lab manager, and problem solver with self-starting background in the research project lifecycle.
Skills : Elisa, Validation, SPC, Client Services, Fluent In Both English And Spanish
- Design and develop revolutionary adaptive optics products for highly discerning government customers.
- Originally tasked as technical liaison to optical design consultant until his work was found deficient.
- Promoted to primary optical designer and lead responsible for all product deliverables, laboratory experiments, verification testing & troubleshooting.
- Conceptualize, innovate, design, develop, and analyze novel optical and imaging systems from the initial "white-board" concept to final deliverable product.
- Use ZEMAX to model and analyze standard and non-standard optical and sensor components (asphere and anamorphic lenses, off-axis parabolic reflectors, multi-dielectric beamsplitters, fiber optics, LED and laser sources, near-infrared and visible cameras, photo-detectors, etc.) to ensure adherence to customer specifications and system-level quality requirements.
- Perform thermal analysis, sensitivity analysis, tolerance analysis, and Monte Carlo Simulations to understand the sensitivity of design and ruggedize where needed, specify custom optical components with tolerances, thereby ensuring ease of manufacturability and environmental compliance of final product to predicted design performance.
- Conceive, design, analyze, procure, build and align low-cost air-spaced triplet lens assembly that replaced the consultant's expensive and un-producible 7-element design.
Sr. Scientist Resume
Summary : Highly qualified Senior Scientist with experience in the industry. Good communication skills, analytical & problem-solving ability and a great team player. To attain a challenging position in the field of Chemistry and to provide strong support to various cross-functional departments and contribute to the overall success of the company.
Skills : Research, Management, Microsoft Office, Operations, Public Speaking, Relationship Management, Team Building, Technical Writing, Teaching.
- Developed formulations, coating methods, and methods for making porous films, nanostructured films, antireflective coatings, chemical barrier layers, and thermal barrier layers for solar cell manufacturing.
- Developed functional inks, dispersions, and nanocomposites used for electronic applications.
- Invented novel methods to convert nanoparticle coatings into films of semiconductor, conductor, and dielectric.
- Invented novel manufacturing methods for core-shell nanoparticles and nano-pigments.
- Managed interns, technicians, and research associates.
- Defined and executed project plans for task force teams of engineers and scientists.
- Worked closely with marketing and business development team to create product specifications and maintain communications with international partners.
Certified Senior Scientist Resume
Headline : Certified Senior Scientist with 5 plus years of experience in process engineering and technology development. With excellent problem-solving skills and experience in heat and mass transfer processes, A motivated towards improving product and process efficiencies in the energy and water sectors to enable sustainable development.
Skills : Research, Management, Microsoft Office, Operations, Public Speaking
- Designs and performs progressively more complex experiments and procedures independently in accordance with all applicable regulatory requirements as defined by protocol, method and standard operating procedures.
- Utilizes equipment, facilities, and personnel to produce sound specific results in a timely fashion for clients and point of contact for internal and external contact.
- Trains analysts on various testing methods specific to project and supervise the day-to-day activities in the laboratory working under prescribed procedures.
- Performs Andersen Cascade Impaction (ACI) and Dose/Content Uniformity (DUSA) analysis of drug products for commercial stability and release.
- Conducts feasibility studies for method development pertaining to trace analysis and impurity structure determination (NMR, HPLC, Mass Spectrometry, FTIR) within the trace analysis group.
- Develops GMP-compliant NMR identification/quantitation methods for pre-clinical active pharmaceutical ingredients (API) and drug formulations.
- Team lead for inhalation product development (IPD) investigations, corrective actions/preventative actions (CAPA), and root cause analysis (RCA) determination for OOT and OOS results.
- Coordinator of non-conformance reports, and system administrator of non-conformance database.
Bachelor Of Science
Project Lead/ Senior Scientist Resume
Summary : Project Lead/ Senior Scientist with a successful track record driving global initiatives, from conception to implementation, through exemplary team leadership skills. Recognized for using exceptional planning and coordination skills to advance multiple projects, from proof of concept to regulatory submission status. Strong strategic thinking and contingency planning skills that delivered a bottom line impact aligned with business objectives.
Skills : Microsoft Office, MS Access, Sigmaplot, Sigmastat, Phoenix/WinNonlin, PKS, NONMEM, R, Trial Simulator, JMP Sharepoint, Elsevier, Science Direct, Pharmapendium
- Project team representative for compounds in Early and Late Development, and Product Life Cycle Management for diabetes, anti-fungal, oncology, cardiovascular and neuroscience therapeutic areas.
- Maximized the success of projects by ensuring strategic development planning, data quality and generation of successful regulatory strategies.
- Managed multiple concurrent projects and led various process improvement initiatives.
- Managed the development and implementation of strategic project team initiatives for the successful conduct of the development of a compound from discovery to regulatory submission.
- Collaborated with project teams to develop strategic novel approaches such as innovative study designs, optimal sampling schemes, and blood spot sample collection methodologies to generate high-quality data.
- Researched and trained employees to receive the knowledge, skills, and competencies with the practical skills and knowledge that relate to specific project needs.
- Authored and reviewed PK, PK / PD, POPPK components of internal clinical documents (protocols, reports, project summaries, and development plans), briefing books, and regulatory submission documents
Bachelor Of Science
Senior Scientist Resume
Headline : Highly self-motivated Ph.D. scientist with strong interpersonal skills and a demonstrated ability to effectively lead and integrate information from various disciplines in a collaborative environment. Expertise in neuroscience research, especially in neurodegenerative diseases, cognitive deficits in ne uropsychiatry diseases, and neuroinflammation. Proficient in target identification and validation, disease signaling research, cell based assay development, and genetically engineered animal model generation and characterization.
Skills : Technology Assessment, Competitive Analysis, VBA, C++, Six Sigma Green Belt, Process Engineering, Process Improvement, Fortran, Reaction Kinetics, Lab Experiments, Neural Networks, Optimization, Concept Development.
- Investigated the pathophysiology of various diseases with a focus on neurodegenerative diseases, cognitive deficits in neuropsychiatric diseases, and neuroinflammation.
- Designed and executed disease signaling research for target elucidation by using in vitro cellular mode (primary neuron, microglia, primary neuron/microglia co-culture, etc.) and in vivo transgenic/ knock out animal models.
- Identified novel drug targets and investigated the targets' biological functions which are involved in neuroinflammation, synaptic function, neuronal survival, neuronal activity, and adult neurogenesis.
- Proposed and developed a research plan on neuroinflammation with a focus on microglia over-activation, neuron-microglia interaction, and immune-brain communication.
- Developed molecular/cellular assays including enzyme assays, reporter assays, RNAi, microelectrode arrays, multiplex ELISA assays, flow cytometry, fluorescent imaging, etc.
- for target validation and compound screening.
- Characterized transgenic/knockout animal models to elucidate target genes' (gain/loss of) function in disease pathophysiology.
- Summarized and published research findings in peer-reviewed journals and scientific conferences.