Scientist, Analytical Development Resume Sample
Jacquelyn Crist
284 Gia Hollow,
Detroit,
MI
+1 (555) 687 3161
Work Experience
Senior Scientist, Analytical Development
06/2015
-
PRESENT
Boston, MA
- Relevant experience with Ph.D
- Lead analytical project efforts, deliver project milestones on-time and on-quality, and represent analytical on cross-functional project core teams with representatives from Project Management, Process / Bioprocess Chemistry, Engineering, Manufacturing, QC, and QA
- Qualify and evaluate analytical methods for the transfer to cGMP Quality Control laboratories for method validation
- Deliver timely and comprehensive written (laboratory notebooks, SOPs, and development and qualification protocols / reports) and oral communications to both internal and external stakeholders
- Interact on a regular basis with the project/product managers and customers to understand the project requirements and deliver effectively
- Excel in a team environment through concise and transparent communication and effective collaboration
- Contribute to or lead technical departmental and cross-functional process improvement initiatives
- Well-organized and detail oriented, able to effectively prioritize, interact cooperatively and effectively with others in a matrix organization and consistently demonstrate reliability, responsibility and independence
Scientist, Analytical Development
03/2010
-
12/2014
Chicago, IL
- Demonstrated success in contributing to the advancement of projects, project teams, and process improvements
- Well-versed in regulatory requirements to assure appropriate design and execution of drug development and manufacture
- Champion new analytical technologies that can be applied to process and drug development
- Coordinate information exchange and manage data generated by contract testing labs
- Comply with SAFC safety policies, practices and SOPs
- Develops project or significant technical strategy within area of expertise
- Leverages technical skill(s) as a resource/expert within the department
- Prepares and coordinates completion of technology transfer documentation, CMC sections of regulatory documents, or validation plans and reports within expertise for review
- Coordinates transfer of projects as necessary
Scientist Analytical Development
03/2005
-
02/2010
Detroit, MI
- Identifies and plans broader technical objectives (project and scientific related) and initiates processes to meet objectives with input from manager as needed
- Identifies and recommends vendors as appropriate
- Significant experience with a broad variety of biochemical analytical techniques, including but not necessarily limited to liquid chromatography, gel or capillary electrophoresis, spectrometry and spectroscopy methods
- Able to lead cross-program development activities for multiple methods
- Able to conduct troubleshooting for complex technical issues and to lead major characterization studies
- Strong understanding of protein structure/function and of technical and regulatory expectations regarding analytical development and product characterization
- Serves as a SME for more complex methods
- Defines critical technical or scientific gaps within AD-Bio
- Develop and execute analytical experiments
Education
Washington Adventist University
2000 - 2005
Science's Degree in Biology
Professional Skills
- Strong oral and written communication skills, with experience in maintaining laboratory notebooks and preparing technical reports
- Strong Scientific problem-solving skills strongly desired
- Strong oral and written communication skills, with experience in preparing protocols and technical reports
- Strong problem-solving and troubleshooting skills, capabilities in experimental design and execution, as well ability to work independently are essential
- Excellent verbal and written communication skills and ability to work in a dynamic, multi-disciplinary, research and manufacturing environment
- Prior cGMP/GLP training and experience working in a cGMP/GLP environment desirable, but not required
- Serve as direct supervisor to Associates within the group, providing technical mentorship and attending to long-term skills development
How to write Scientist, Analytical Development Resume
Scientist, Analytical Development role is responsible for analytical, development, research, interpersonal, software, design, manufacturing, collaboration, training, analysis.
To write great resume for scientist, analytical development job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Scientist, Analytical Development Resume
The section contact information is important in your scientist, analytical development resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Scientist, Analytical Development Resume
The section work experience is an essential part of your scientist, analytical development resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous scientist, analytical development responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular scientist, analytical development position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Scientist, Analytical Development resume experience can include:
- Proven analytical (HPLC, Dissolution, spectroscopy, etc.) skills and ability to work independently
- Strong experience in NDA and/or BLA CMC authoring, filing and approval
- Prior experience with training and mentoring other technical staff
- Ph.D with 0-2 years experiences and with in-depth knowledge of analytical principles, including practical experience with HPLC, GC, and MS
- Five years of relevant analytical experience in the pharmaceutical industry, including direct experience with oral drug products
- Maintain compliance with cGxP regulations and updated skills training
Education on a Scientist, Analytical Development Resume
Make sure to make education a priority on your scientist, analytical development resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your scientist, analytical development experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Scientist, Analytical Development Resume
When listing skills on your scientist, analytical development resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical scientist, analytical development skills:
- Strong leadership skills (1 - 3 years of leadership experience) and ability to influence without direct authority in multi-disciplinary teams
- Proven skills in formulation development support, analytical method development, transfer, validation, release, & stability
- Proven skills in analytical method development and validation of small molecules (<900Da) and/or larger molecules
- Proven ability to work in a highly collaborative scientific environment with strong communication skills
- Good understanding of ICH validation guideline and GMP experience are required
- Strong collaboration skills in international and intercultural teams
List of Typical Experience For a Scientist, Analytical Development Resume
1
Experience For Senior Scientist, Analytical Development Resume
- Ph.D. in chemistry or related scientific discipline with 0-2 years of pharmaceutical industry experience, or M.S. with 5-10 years of relevant experience
- PhD in a relevant scientific discipline with ≥ 5 years of industry experience
- Performing routine calibration/validation of analytical equipment according to relevant SOPS and protocols
- Practical experience with reverse phase chromatography and mass spectrometry
- Preparing technical documentation (procedures, protocols, reports, etc)
- Monitoring/maintenance of high level of laboratory housekeeping
2
Experience For Principal Scientist, Analytical Development Resume
- Checking and verifying of analytical work in accordance with GMP
- Performing routine and complex analyses in accordance with designated specifications, protocols and relevant SOPs
- Reviewing routine analytical data generated by colleagues within the Analytical Development group
- Ensuring that laboratory analytical equipment is appropriately qualified, calibrated and used in accordance with internal SOPs
- Assisting with regulatory and client audits
- Understanding of regulatory commitments, e.g. GMP, ICH, COSHH etc
- Resource planning and project forecasting with external CRO’s; sample testing submissions and coordination at external labs
- Other tasks determined during the annual objective setting process and by KPIs
- Represents functional area on project teams by communicating activities from designated functional area to project team
3
Experience For Associate Scientist, Analytical Development Resume
- Responsible for own workload involving designated clients and projects
- Evaluation and modeling of analysis results
- Identify bottlenecks in the analytical processes and work with supporting groups to automate or streamline them
- Maintain proper documentation of all experimental procedures and results
- Write analytical methods, prepare technical reports and presentations which summarize procedures, study results and provide data interpretation
- Identify and resolve unexpected issues
- Quick learner and able to work in a fast-paced environment
- Contributes significantly and independently to multiple projects within functional area
4
Experience For Research Scientist, Analytical Development Resume
- In-depth knowledge of separation sciences, including (U)HPLC, GC, RP, IC, AEX, and chiral chromatography, and mass spectrometry with extensive laboratory experiences
- Hands-on experience with other characterization techniques such as NMR, Raman, IR, KF, etc
- Knowledge in drug substance /drug product processing and pharmaceutical sciences as they relate to ASOs and pharmaceuticals
- Develop and qualify new analytical methods
- Knowledge in formulation development and experience in supporting the development of enabling formulations and analyzing drug delivery systems, such as microspheres and liposomes
- Work with minimal supervision and exercise independent judgment on matters of significance
5
Experience For Scientist Analytical Development Resume
- BS or higher in Chemistry or related field
- Write, edit and review SOPs, batch production records and reports with guidance
- Expertise in physical and chemical stability kinetics
- Manage and execute transfer of analytical methodologies from internal QC and analytical development groups to external CRO’s
- Oversee and manage outsourced activities at partner CRO’s, to ensure timely generation of high quality data
- Review of data and generated protocols and reports at partner CRO’s
- Ensuring all analytical work (method transfer/development, formulation support, method validation, technical batch stability, etc) is performed and reported within agreed timelines
6
Experience For Scientist, Analytical Development, Biologics Resume
- Work hands-on in the laboratory to develop and implement analytical methods for release and stability testing for drug substances and drug products
- Conduct testing and interpret data to drive chemical process and formulation development, and to provide supportive data for regulatory filings
- Maintenance of technical capabilities commensurate with job role. Any other task deemed appropriate by line management
- Identify and track process impurities and degradation products, manage formal and informal stability studies, apply statistical methods of analysis, and guide project team activities based on stability outcomes
- Author methods, operating procedures, protocols, analytical development reports, and the analytical sections of regulatory filings
- Author methods, protocols, technical reports, and the analytical sections of regulatory filings
- Collaborate with Chemical Development and Formulation Development scientists to meet program goals
- Contribute technical leadership, scientific judgement, and an enthusiastic attitude to our fast-paced and dynamic environment
7
Experience For Senior Scientist, Analytical Development PCS Resume
- Establish phase-appropriate specifications and control strategies for materials, design studies to support late-phase specification development, and author justification of specification documents
- Collaborate effectively with the Chemical Development, Formulation Development, Quality, and Regulatory groups to meet program goals
- Lead analytical activities for programs at all stages of development, and represent the Analytical Development function on project CMC teams
- Ph.D. in chemistry or related scientific discipline
- Contribute leadership, independent judgement, and an enthusiastic attitude to our fast-paced and dynamic environment
- Acting as a Scientist means coordinating and planning of analytical development activities including method development, method transfers, product characterization, process development support, toxicology material supply as well as overall product quality evaluation
- Knowledge about clinical development and corresponding regulatory requirements in EU, US and China advantageous
- 1) providing analytical support towards the development of multiple biologic programs from the clinical stage through commercialization involving both internal efforts and collaborations with external partners,
- 2) structure elucidation and characterization approaches as applied towards glycoprotein analysis and associated process development efforts
8
Experience For Scientist, Analytical Development Resume
- Development of analytical procedures
- Participation in analytical /regulatory projects
- Creation of analytical procedures and CoAs
- Conduct of and/or participation in stability studies
- Creation of relevant instructions, protocols, reports
- Other tasks as assigned by the supervisor, and tasks based on a specific appointment
9
Experience For Senior Scientist, Analytical Development Resume
- Implementation of and adherence to all the instructions and requirements for safe work, environment protection, and property protection
- Develop mass spectrometry assays to support protein characterization efforts for clinical and pre-clinical programs
- Work with other Process Development functional groups to ensure program timelines are kept
- Author reports for analytical characterization and technical transfer
- Provide expert guidance to research groups on assay design
- Highly motivated, flexible, and multi-tasks
- Develop phase appropriate control strategies to support the pipeline of pharmaceutical and antisense oligonucleotide drugs
- Develop platform strategies to perform method development and qualification to support drug substance process development, including starting material, intermediates, and API, and formulation development
10
Experience For Principal Scientist, Analytical Development Resume
- Excellent skill in Microsoft Office, data analysis software, and other applications
- Author/review filing documents/technical reports to support regulatory applications
- Maintain complete and accurate records of laboratory work in conformance with company SOPs and training
- Write, review, and edit technical documents and SOPs
- Participate in the development of bioassays and immunoassays
- Work with a cross-functional team to develop, adapt, remediate, execute, and document analytical methods to study and characterize processes for production of autologous T cell therapy products in Product Sciences
- Design and execute experimental approaches and new analytical technologies and assist with continuous improvement of analytical tools
- Write, review, and edit accurate technical documents
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, analytical method development, technology transfer, method qualification/validation, and process development
List of Typical Skills For a Scientist, Analytical Development Resume
1
Skills For Senior Scientist, Analytical Development Resume
- Skills in analytical method development, specifically regarding separation science (HILIC, SEC, IEC, HIC, icIEF, CZE, etc.) and LC/MS analysis of glycoproteins
- Experience with LCMS and NMR strongly desired
- Prior supervisor experience is required
- Effectively coordinate and track the progress of multiple Analytical related projects
- Excellent team player with the ability to build strong networks with peers
- Ph.D. with 8 years’ experience in Chemistry; MS with 12 years’ experience
2
Skills For Principal Scientist, Analytical Development Resume
- Experienced in developing Biacore and/or ELISA binding assays to support antibody characterization for binding to FcRn, FcgR, or antigens
- Effective in managing multiple competing activities and delivering to timelines
- Experience in developing potency data analysis templates using Softmax Pro, PLA, or other data analysis software
- Experienced with writing/reviewing scientific documents
- A well-grounded foundation in other analytical techniques such as MS, NMR, UV and IR spectroscopy, with strong understanding of the underlying principles
- Strong knowledge of biologics method development (potency cell-based bioassay, potency and binding ELISA, CE, etc) is a string advantage
- Two years industry experience (not including academic work)
3
Skills For Associate Scientist, Analytical Development Resume
- Experienced in the development and optimization of cell-based assays and binding assays
- Experienced in working with cultured cells and cell line characterization
- Experience working in GLP/GMP environment is required
- PhD in Chemistry, Chemical Engineering, Material Science, Crystallography (or relevant discipline) with required years of experience
- PhD in Chemical Engineering, Material Science, (or other relevant discipline) with required years of experience
4
Skills For Research Scientist, Analytical Development Resume
- Ph.D. Chemistry/Biochemistry with 0-2 year experience in biotech industry or post-doc training in protein MS
- B.S. in Chemistry/Engineering or related field with 4-8 years of experience
- A strong background in analysis and characterization of glycans using separation techniques and mass spectrometry
- Experience with cell line generation using transfection / infection techniques
- Practical experience and working knowledge of analytical method development in accordance with regulatory guidances and best practices
- Experience working with CROs/CMOs is also highly valued
- Transfer analytical methods to external laboratories and oversee phase-appropriate validation, testing, and data receipt
- Experience working internally with multidisciplinary teams, and externally with contract research organizations and contract manufacturers
- Extensive experience working on protein mass spectrometry assays, particularly peptide map and intact mass is required
5
Skills For Scientist Analytical Development Resume
- Experience supporting product development of small molecules, peptide/protein characterization, pre-formulation, and method development
- Design, develop, optimize, phase-appropriately validate, and transfer potency methods to internal and external QC testing labs
- Experience working in a cGMP analytical laboratory is required
- Experience with working with CROs
- Experience managing scientists in a direct or matrix environment
- Experience writing protocols, summary reports and test methods
- Manual dexterity required to operate office equipment (e.g. computers, phones, etc.)
- Experience with glycosaminoglycans (GAGs) and/or protein polysaccharide conjugates desired
- Lead development and validation of small molecule analytical methods for the characterization of drug substance
6
Skills For Scientist, Analytical Development, Biologics Resume
- Lead development and validation of analytical methods for the characterization of drug substance
- Develop, validate, and transfer methods for analysis of drug substance and drug product
- Prioritize tasks and responsibilities for projects
- Lead and guide method development, validation, and troubleshooting at CROs
- Knowledge and hands-on experience in biologics characterization with mass spectrometry (LC-MS) based techniques is required
7
Skills For Senior Scientist, Analytical Development PCS Resume
- Understands and applies method qualification/validation per the ICH guidelines
- Drafts and executes qualification/validation protocols. Writes procedural SOPs and reports
- Prepare documents (methods, experimental plans, SOPs, development reports, validation protocols and reports)
- Deep practical experience with normal and reverse phase chromatography, and proficiency with Empower software for data collection and analysis
- Strong scientific expertise in analytical and protein chemistry and the characterization of biologics
- Wide practical experience with analytical technologies (e.g. chromatography, electrophoresis, ELISA, SPR, Glycoanalytics, mass spectrometry)
- Validation/qualification of analytical procedures
- Excellent written and interpersonal communication; ability to influence and collaborate in a team environment
8
Skills For Scientist, Analytical Development Resume
- Maintain, calibrate, and operate analytical equipment and instruments
- Develop new chemical assays; write method qualification/validation protocols and reports
- Familiarity in method development, qualification and validation around common pharmaceutical analytical techniques
- Demonstrated ability to work successfully in a highly collaborative, team oriented, customer focused environment
- HPLC/UPLC experience is required
- Experience in other NBE related areas like formulation, process development, manufacturing or quality control are beneficial
- Experience in leading people is beneficial
- Excellent understanding of both scientific and regulatory requirements in the area of pharmaceutical development
- Experience within a similar laboratory environment
9
Skills For Senior Scientist, Analytical Development Resume
- Build strong cross-functional networks in a local and global environment
- Relevant industry experience in the area of pharmaceutical development of biologics
- Experience in Quality by Design (QbD) and Design of Experiment (DoE) are beneficial
- Ph.D in chemistry, biochemistry, or related field with 7-10 years of relevant experience in protein analytical chemistry
- Beginning to impact not just AD but multiple departments. This impact is achieved through leading groups and contributing to cross-functional teams
- Initiating and introducing new scientific knowledge into the area and keeping an updated scientific and regulatory knowledge in defined fields
- Writing study protocols, reports and regulatory documents, and writing and reviewing SOP’s
- Initiating and introducing new scientific knowledge into the area and keeping an updated scientific and regulatory knowledge in defined labs
- Providing technical leadership through informal and formal training mechanisms
10
Skills For Principal Scientist, Analytical Development Resume
- Leading and coordinating activities at CROs/CMOs
- Presenting and defending project results both internally and externally
- Writing/reviewing, raw data, protocols, reports, SOP’s, specifications, risk assessments and regulatory documents
- Understanding of techniques for polymer characterization, including GPC and viscometry
- Providing analytical support for investigative studies and troubleshooting analytical issues
- Working knowledge and understanding of global regulatory requirements and expectations for product registration and ICH Stability Guidelines
- Designing and conducting stability studies for drug substance and drug product to satisfy global regulatory requirements
List of Typical Responsibilities For a Scientist, Analytical Development Resume
1
Responsibilities For Senior Scientist, Analytical Development Resume
- Proven skills and ability to work collaboratively with both internal and external partners
- Post-doctoral experience and strong publication record
- Basic math and software skills (MS Excel, Word, PowerPoint, Google sheets)
- Analytical method development and qualification experience in molecular biological techniques such as quantitative PCR (qPCR), ELISA, and flow cytometry
- Experience with mammalian cell culture and biological potency assays
- Maintain strong knowledge of GMPs
- Leading pharmaceutical analytical work. Arrange, evaluate, present and defend results to Director
2
Responsibilities For Principal Scientist, Analytical Development Resume
- Writing study protocols, reports, regulatory documents, and SOPs
- Demonstrating method suitability for applications to drug substance and drug product development, scale-up and commercialization
- Interacting with contract laboratories to troubleshoot analytical issues and/or address lab incidents and investigations
- Understanding of MOA for antibody and gene therapy-based therapeutics
- Working knowledge of cGLP/cGMP and applicable FDA, EMA, and ICH guidances
- CMC Project Manager: Monthly reporting, budgeting and forecasting
3
Responsibilities For Associate Scientist, Analytical Development Resume
- Manage laboratory including ordering supplies, laboratory organization, instrument preventive maintenance scheduling, and instrument logbooks
- Participate in Assay Qualifications including writing protocols and reports and reviewing data
- Thorough understanding of HPLC and analytical chemistry methodologies, including troubleshooting and root cause analysis
- Typical office and laboratory bending, stooping and lifting requirements
- Outsource pharmaceutical development activities to CROs/CMOs including selection of and writing contracts
- Support non-GMP and GMP sample testing, coordination of sample management, and entry of results into LIMS-based system or non-GMP testing sample database
- Implements technical training and coaching to staff members
- Independently develop new and innovative analytical methods, improving existing ones, and troubleshoot product quality problems
4
Responsibilities For Research Scientist, Analytical Development Resume
- Thorough understanding of method development principles for HPLC and for sample preparation for at least assay, related substances, and uniformity testing
- Support drug substance process development including characterization of starting materials, intermediates, and final API
- Familiarity with synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing or pharmaceutical sciences
- Familiarity with synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing and/or pharmaceutical sciences
- Accurately follow established test methods, procedures, and pharmacopeia chapters (e.g. Dissolution) to generate data essential for strategic decision making
- Lead team by ensuring execution of work assignments by laboratory staff to meet timelines
- Work according to safety and quality regulations/guidelines (SOP’s)
- Contribute to the establishment of an internal GMP bioassay and immunoassay testing function
- Act as mentor/coach for developing Research Chemists and Engineers
5
Responsibilities For Scientist Analytical Development Resume
- Development of analytical methods and transfer to internal Product Development and QC laboratories, and CMOs or testing laboratories
- Perform analytical testing to support process development
- Support training of colleagues in QC and Product Development
- Interact with third parties and testing laboratories
- Develop analytical methods and/or transfer assays in from outside labs to support process development and characterization/release testing
- Proficiency in separation sciences, including basic forms of chromatography, i.e. (U)HPLC, GC, RP, IC, AEX, chiral chromatography
6
Responsibilities For Scientist, Analytical Development, Biologics Resume
- Proficient with a wide range of instrumentation platforms, e.g. Empower and ChemStation, and software applications, including Microsoft Office
- Provide technical leadership through informal and formal training mechanisms
- Attend training sessions as appropriate
- Assist in maintaining a clean and safe workplace on a daily basis
- Provide scientific guidance, leadership, and training to others within the department
- Follow laboratory procedures with attention to detail and successfully execute experiments at the bench
- Develop and execute chemical and instrumental methods (e.g. HPLC, GC, TGA, DSC, MS, FTIR) of analyses for development compounds, drug substances, raw materials, intermediates, drug product, and packaging materials
7
Responsibilities For Senior Scientist, Analytical Development PCS Resume
- With supervision, plan and execute in-house stability studies for drug substance’s, intermediates, and prototype drug products
- With supervision and as appropriate, assist/lead the development of analytical methods, investigations for out of specification, out of trend, and/or anomalous results
- With supervision, collaboratively plan and execute cross functional studies for chemical development and formulation development
- Recognize and respond to unexpected or anomalous observations in all activities
- Provide detailed reviews of peer generated data as well as that generated from contracted service providers
8
Responsibilities For Scientist, Analytical Development Resume
- Maintain the inventory of laboratory consumables and clean glassware
- Coordinate vendors service calls for repair and maintenance of laboratory instruments, with training perform routine maintenance of laboratory instrumentation, maintain complete and accurate records of instrument service and repairs in conformance with company SOPs and policies
- Extensive knowledge and application of HPLC and dissolution (preferable) techniques for both basic and complex drug product formulations is required
- Identify and solve complex technical issues that correspond to atypical or out-of-specification/trend test results as well as instrumentation and methodology related
- Willingness to learn new skills, assist on a wide variety of projects and be adaptable to new areas of development as priorities change within the department
9
Responsibilities For Senior Scientist, Analytical Development Resume
- Provide technical leadership on interdepartmental initiatives through technical and CMC teams
- Evaluate and/or develop new technologies and identify proprietary technical opportunities
- Direct and foster the professional development of scientific associates
- Routine work involvement and weekly meetings with laboratory team to review progress, work through issues and bring resolution to problems, and communicate to laboratory management and coordinate with other leaders for assistance and closeout of work activities
- Plan comprehensive stability studies
- Write project proposals, and development reports
- Coordinate activities of outside resources such as consultants and vendors
- Participate in technology transfer
10
Responsibilities For Principal Scientist, Analytical Development Resume
- Sound scientific judgment is reflected in data summaries, reports and presentations
- All internal safety, quality, and regulatory requirements are followed
- Document all experiments and results thoroughly with detailed observations
- Exercise technical discretion in the design, execution and interpretation of experiments that contribute to project strategies and goals
- Critically assess experimental data and provide interpretation of results
- Prepare technical reports, summaries and protocols
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