Associate Scientist Resume Samples

Description :

1. Performing qualitative and quantitative testing on HPLCs, UV/Vis, FTIR and GC/MS (headspace, direct injections and derivatization) instruments.
2. Operating, troubleshooting, tuning, calibrating and maintaining laboratory equipment or instruments necessary to support testing, as well as generating, executing and drafting final reports for IQ/OQ/PQ.
3. Validating testing methods on several instruments (Shimadzu, Waters, GC/MS -QP2010) for projects.
4. Proposed new procedures for new equipment and revised current procedures in accordance with ISO9001 standards; generating protocols and training associates in ultra-filtration using tangential forward flow (TFF) fundamentals in accordance with ISO9001 standards.
5. Planning and developing projects; coordinated efforts between customers, manufacturers and senior management to deliver results to ensure accurate test data.
6. Performing extractables/ leachables testing on customer pharmaceutical/biopharm products.
7. Resolving unknown substances from customer samples by using wet chemistry to analyze Non Volatile Residue (NVR) using Total Dissolved Solids/ Total Suspended Solids testing to determine impurities within solvents and solutions.

Experience

2-5 Years

Level

Junior

Education

Bachelor Of Science

Description :

1. Performed opsonophagocytic assays and ELISAs that involve a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical compounds in a variety of biological matrices.
2. Compile informative data and organize records to ensure compliance with regulatory requirements (USP and EP) and standard operating procedures (SOPs).
3. Adhere strict compliance with basic scientific principles, procedures, and theories in analyzing products.
4. Assume full responsibility in maintaining laboratory cleanliness, order, and stocks of supplies.
5. Member of review team responsible for reviewing as well as lab authorizing analyst procedures, ensuring data integrity prior to submission to Quality Assurance (QA) and client.
6. Perform data regulation responsibilities to ensure compliance with complex quality assurance requirements and standards Notable Achievements: Conducted bioanalytical methods as well as research and development projects to include the development and implementation of new assay methods, enhancement of existing methods, and transfer of client-provided methods.
7. Performed data analysis to determine whether data is or is not acceptable according to strict and varying parameters.
8. Routinely prepared and dispensed up to forty liters of various reagents utilized for performance of the client-provided assay.

Experience

7-10 Years

Level

Management

Education

BS In Biology

Description :

1. Coordinate the analytical portion of client studies based on study protocols and according to regulatory guidelines.
2. Study Director for analytical method validation studies and Contributing Scientist (or PI) for dose concentration verification portion of client studies based on study protocols and according to regulatory guidelines.
3. HPLC analytical method development, troubleshoot experimental problems independently, and prepare documentation in accordance with Good Laboratory Practices (GLP) guidelines.
4. Draft/write SOPs and procedures for the formulation and analytical labs.
5. Draft/write deviations, amendments, protocols, dose formulation analysis sub-reports, and method validation study reports.
6. Develop and maintain proficiency in analytical instrumentation operation and maintenance.
7. Participate in training and oversight of analytical laboratory chemists, and provide support to technicians, scientists, and study directors.
8. As Study Director, developed analytical methods and performed 9 method validation studies in support of nonclinical research, aided in the completion of an additional 6 method validations, and completed 2 dozen dose formulation analyses as Contributing Scientist/Principal Investigator.

Experience

7-10 Years

Level

Management

Education

Engineering Geology

Description :

1. Immunochemistry cell scientist responsible for research, development, validation and production of various pharmaceutical compounds for various top pharmaceutical companies.
2. Completion and review of results of complex sample analysis to quantitatively measure pharmaceuticals in a variety of biological matrices under GMP, GDP, GLP FDA regulated and non- GMP, GDP, GLP studies.
3. Various ELISA testing to include neutralizing antibody assays and immunochemistry assays for screening, specificity, immunodepletion and endpoint titer.
4. Experience in working with bio-hazardous materials in a BSL 2 laboratory, radioactive materials and sterile enclosed cell culture environment.
5. In-depth knowledge of SOPs, clinical FDA phases, experiment documentation, laboratory confidentiality and ethics.
6. First team member assigned to the cell lab under the supervision of a principal investigator.
7. Managed the expansion of the lab, projects and productivity while team building with five other team members.
8. Successfully increased clientele for numerous studies in the cell lab by culturing various cell lines and effectively performing first cell based sample analysis for PPD-Richmond.

Experience

7-10 Years

Level

Management

Education

Biotechnology Management

Description :

1. Aseptically prepare, screen, test, and manage the inventory of critical reagents and components used in biofunctional Serum Bactericidal and Opsonophagocytic assays supporting phase 2 and phase 3 clinical and non-clinical testing, development, and throughput.
2. Practice wet chemistry techniques in the quality control of critical reagents, including pH, spectrophotometry, turbidity etc.
3. Develop & perform all aspects of preclinical & clinical functional assays, including Serum Bacterial and Opsonophagocytic assays for meningococci & pneumococci vaccine research and all required documentation.
4. Create and update documents associated with biofunctional assays, including standard operating procedures, status reports, and data analysis.
5. Practice Lean Six Sigma techniques to improve efficiency and drive progress and goal completion.
6. Continuously improve the efficiency and output of reagent and solution preparation procedures; 3 times more efficient in some cases.
7. Satisfactorily complete all cGLP safety training in compliance with standard operating procedures and departmental regulations.

Experience

0-2 Years

Level

Entry Level

Education

BS In Biology

Description :

1. Contributed to the establishment of a medium throughput vector cloning service designed to support plant transformation pipeline for both model and core crops.
2. Designed cloning strategies using VNTI and made maps for requests as needed along with the design and ordering of primers.
3. Managed information for incoming requests from nominators in LIMS and Access.
4. Isolated genes directly by PCR from gDNA, cDNA, and pDNA for vector cloning.
5. Directly cloned and subcloned hundreds of vectors using both Gateway technology and conventional cloning methods available.
6. Transformed Agrobacterium to support both the bioassay and crop transformation pipeline.
7. Isolated and tested several transcription terminators candidates providing expression profile data in both a transient and stable reporter system to test functionality.
8. Analyzed promoter and intron candidates in both T0 and T1 plants using GUS staining and MUG assays for gene expression analysis for tool development to initiate platform.

Experience

2-5 Years

Level

Junior

Education

BS In Biology

Description :

1. Oversaw the daily lab management of a biomarker discovery and assay support group for several research targets including cardiovascular disease, metabolic disease and novel chemistry for inflammation.
2. Routinely performed multi-assay analysis on samples from large clinical and preclinical studies eliminating the need for external analysis costs.
3. Developed whole cell assays and novel ELISAs to address unmet research needs in the areas of gene expression (rtPCR) and metabolic disease.
4. Developed and screened proprietary antibodies to meet research needs.
5. Performed preliminary toxicological assays/liver toxicology for potential drug candidates.
6. Constantly expanded the biomarker assay portfolio to meet expanding therapeutic areas.
7. Evaluated and optimized commercially available kits and developed novel in-house immunoassays to meet diagnostic needs.
8. Prioritized, validated and performed 40 assays on 5 different platforms for plasma, serum, urine, tissue lysates and cell culture media in 5 species.

Experience

10+ Years

Level

Senior

Education

Bachelor Of Science

Description :

1. Worked in a team environment with collaboration between direct team members as well as cross collaboration between functional areas and sites.
2. Worked independently on day to day projects.
3. Performance of total radioactivity analysis to determine clearance and the release of subjects for a Human Absorption, Distribution, and Metabolism (AME) study.
4. Performance of in vivo and in vitro assays including blood to plasma partitioning, plasma protein binding, covalent binding, determination of nucleoside binding and unstable NTP levels in tissues, microsomal stability and clearance and hepatocyte stability and clearance.
5. Use of the Cell counter, Hamilton robot, the Biomek robot and mass spectrometer.
6. Data analysis including quantifying mass spectrometry data and using software to calculate intrinsic clearance as well as record keeping in the electronic notebook.
7. Completed six-sigma yellow belt training and participated in collaboration for 5S activities in the lab including certification.

Experience

7-10 Years

Level

Management

Education

BS In Animal Science

Description :

1. Assist as well as perform lab reactions prior to their scale up for pilot plant and plant trials.
2. Perform characterization tests on food products (moisture analysis, viscosity, color, microscopy, particle size, starch concentration).
3. Perform various analytical tests and prepare samples for analytical tests (iodometric titration for oxidizing species, pH measurement, and sediment volume, HPLC, starch concentration by YSI).
4. Use LIMS system for writing reports, sample tracking, chemical inventory, and disposal and submit samples for various analytical and microbiology tests.
5. Operate laboratory computers and soft wares for data entry and analysis.
6. Leadership qualities through mentoring new employees about the project and techniques related to the project.
7. Trouble shoot problems of various complexities while working independently.
8. Follow JSAs and SOPs associated with specific tasks, respect company's GLP/GMP procedures and work under OSHA procedures in the lab.

Experience

2-5 Years

Level

Executive

Education

Master Of Science

Description :

1. Aseptic processing and sterile production of clinical trial pharmaceuticals.
2. Train new hires on all manufacturing/operations equipment and procedures.
3. Comply with current Good Manufacturing Practices (cGMPs) and company policies relating to quality, safety, housekeeping, and cost effectiveness.
4. Assemble and disassemble process equipment on all unit operations for hot melt extrusion, microsphere encapsulation, liposome production or polymer production.
5. Draft standard operating procedures, master batch production records, work instructions, specifications, user requirement systems, and protocols for GMP production.
6. Sterilize process equipment and supplies using an autoclave and/or depyrogenation oven.
7. Raw material weigh/dispense, finished product inspection, packaging and shipping.
8. Qualified in gowning techniques/cleanroom behavior, and experienced using various chemicals, solvents, highly potent active pharmaceutical ingredients and laboratory equipment.

Experience

10+ Years

Level

Senior

Education

Bachelor's In Biology

Description :

1. Designed, performed and analyzed experiments in various purification platforms (affinity, hydrophobic interaction and ion- exchange chromatography, HPLC, TFF, etc.), employing sound scientific and engineering principles.
2. Lead viral clearance process development, including the validation of viral clearance at a CMO.
3. Generated all documentation, as well as reviewed and approved CMO protocols.
4. Implemented a new nanofiltration device, in an effort to maximize the viral clearance process while maintaining compliance with regulatory guidelines.
5. Served as a member of the team responsible for completion of Process Risk Assessment, FMEA document and Quality by Design analysis.
6. Transferred purification methods to a CMO for phase II and phase III clinical manufacturing.
7. Interacted with vendors to identify, evaluate and specify equipment, technologies and/or materials that improved the efficiency of Process Development operations.

Experience

2-5 Years

Level

Executive

Education

Bachelor Of Science

Description :

1. Support Client Company's global biorepository in alignment with Clinical Bio analytical and Discovery Technology and Discovery Analytical Sciences initiatives within Client company's policies and procedures.
2. Sample Receipt, sample shipment, process improvement, organization of ECU's, dispensing and/or destruction of samples.
3. Work with Pharmacology Operations and PCO Management to address sample receipt distribution and sample banking operations.
4. Work with specific internal departments/ lab groups and address questions related to samples receipt functions.
5. Work with specific external clients within sample issue resolution and maintain resolution database.
6. Maintain Matrix bank including inventory and process ordering.
7. Train new hires on basic group structure, daily tasks and procedures.
8. Adherence to laboratory policies, safety procedures and standard operating procedures (SOPs).

Experience

2-5 Years

Level

Junior

Education

Research Management

Description :

1. Independently perform studies for the development of lead formulations.
2. Studies include pH solubility, pH stability, solution and solid state stability, particle size determination, physical and chemical analysis.
3. Responsible for writing and successfully executing protocols, collecting and analyzing data, providing development and final formulation reports to clients.
4. Working closely with clients to provide critical data and information as needed.
5. Independently draft addendums for additional client needs.
6. Key team member in the production of materials for GLP toxicology studies following pre-approved batch records.
7. Actively participated in multiple client requested quality assurance site evaluations.
8. Routinely perform analytical testing, stability indicating HPLC method qualifications and studies for stability, solubility, excipient compatibility and particle size analysis.

Experience

2-5 Years

Level

Junior

Education

Bachelor Of Science

Description :

1. Provide Support for Customer Analytical Service Feed Lab Responsible for the daily routine operation and maintenance of four HPLC instruments for drug assays, using solid phase and wet extraction sample preparation techniques as per cGMP requirements.
2. Perform periodic qualification tests and calibrations of HPLC and other lab equipment to comply with GMP requirements.
3. Write protocols and design experiments for developing drug assays in animal feeds.
4. Write standard analytical methods and laboratory equipment operating procedures.
5. Train appropriate personnel as per GMP requirements.
6. Saved company $100,000 annually over a six year period by completing HPLC and spectrophotometric method validations for six drug assays in finished feeds.
7. Provide mentoring for technicians in our department for ongoing growth development.
8. Prepare and deliver technical and safety presentations.

Experience

5-7 Years

Level

Executive

Education

BS In Chemistry

Description :

1. Responsible for running GLP studies from start to finish.
2. Responsible for concluding pre-designed protocols using basic techniques and skills.
3. Responsible for executing protocols, collecting, processing and collecting data.
4. Responsible for executing protocols, processing and collecting data.
5. Responsible for having excellent communication and interpersonal skills with employees, management, and clients.
6. Conducted predesigned studies using laboratory equipment, and calculating such tasks as randomization, allocation and collection of data capture system (Provantis).
7. Responsible for making detailed observations and basic data analysis.
8. Responsible for documenting timely, accurate, litigable, error free lab records, that did not adversely impact the creditability of the data Responsible for administering all compounds.

Experience

2-5 Years

Level

Executive

Education

BA