Scientist, Analytical Resume Sample
Maxwell Thiel
2011 Laurine Forges,
Boston,
MA
+1 (555) 142 2428
Work Experience
Senior Scientist, Analytical
07/2016
-
PRESENT
Boston, MA
- Design, validate and/or implement new dosage forms/analytical methodology including the development of production processes, including all necessary procedures, training, and regulatory documentation
- Participate on project teams as member, leader, or liaison to facilitate the team’s activities and achievement of goals
- Recognize potential process improvements, recommend associated actions, and develop and implement appropriate solutions
- Serve as primary technical expert for related job area for all areas of the company and its’ associated partners
- Manage and coordinate group activities to meet specified departmental and corporate goals and timeframes
- Effectively interpret and defend dosage form/analytical data and reports and interact with Regulatory Affairs in response to official inquiries
- Meet corporate objectives for the development and qualification/validation of assays implementing technologies such as HPLC, CE, spectrophotometry and ELISA to test and characterize proteins and related compounds (e.g., impurities, post-translational modifications)
- Perform routine assays to support pharmaceutical products throughout their lifecycle, such as development samples from Cell Culture and Purification Development, Formulation Development, DS and DP Manufacturing, and Preclinical
Scientist, Analytical
08/2013
-
03/2016
Houston, TX
- Provide technical expertise guidance to address QC deviations and troubleshooting
- Provide technical expertise guidance to antibody product characterization and comparability
- Support the testing of samples for lot release and stability under GLP/cGMP guidelines as needed
- Provide scientific input and demonstrate critical thinking into experimental design and execution
- Compile and summarize test data and perform data analysis
- Write technical development reports and give oral presentations of data at departmental or interdepartmental meetings
- Coordinate with other functional groups to support upstream and downstream, process development studies to meet corporate objectives
- Write, review and edit SOPs and Test Methods for new procedures and assays; review, edit and revise existing SOPs to reflect changes in procedures
Scientist, Analytical Science
10/2007
-
03/2013
Chicago, IL
- Oversee analytical instrument maintenance, calibration and trouble-shooting
- Support the qualification of analytical methods to be used in CGMP testing, including the drafting and review of method qualification protocols and reports
- Responsible for maintaining and ensuring adherence to GLP/cGMP compliance and Agenus Quality Systems
- Author or contribute to analytical sections for IND and BLA submissions
- Understanding of ICH guidelines such as “Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products”
- Understanding and experience with determining critical quality attributes of protein products
- Work as part of an efficient Regional Analytical team. Participate in client and stake holders meetings as required
- Plan own workload and ensure resources allocation in appropriate projects
- Scientific understanding and ability to independently conduct chemical and physical analysis in relevant area
Education
Whitworth University
2002 - 2006
Science's Degree in Biology
Professional Skills
- Excellent communication, technical writing and presentation skills are essential as are excellent organizational and record-keeping skills
- Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required
- Familiar with CMC, Pharmacopeia, ICH and/or GMP;Strong communication skills
- Demonstrated leadership and ability to work effectively with others
- Experience participating in and leading CMC teams is highly desirable
- Subject matter expert in areas relating to analytical method development, transfer, qualification and validation and stability testing
- Hands-on experience with a variety of analytical techniques and instrumentation, including elemental, organics, thermal, and physical measurements
How to write Scientist, Analytical Resume
Scientist, Analytical role is responsible for analysis, techniques, analytical, interpersonal, software, research, technical, reporting, training, coding.
To write great resume for scientist, analytical job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Scientist, Analytical Resume
The section contact information is important in your scientist, analytical 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 Resume
The section work experience is an essential part of your scientist, analytical 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 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 position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Scientist, Analytical resume experience can include:
- Good verbal and written skills with the ability to communicate with clients and colleagues
- Effectively represent the analytical function in CMC and ad hoc cross-functional teams
- Demonstrate clear initiative, risk-taking, and creativity
- Achieve positive laboratory results through a combination of personal hands-on lab experience and guiding the efforts of others
- Knowledge/experience in working with FDA regulated environment (GxP)
- Understand requirements to verify, qualify and/or validate test methods per ICH guidelines
Education on a Scientist, Analytical Resume
Make sure to make education a priority on your scientist, analytical 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 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 Resume
When listing skills on your scientist, analytical 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 skills:
- Experience in problem-solving skills and delivery of technology/transfer/submission-ready technology, data and documents
- Demonstrated oral and written communication skills, especially adherence to laboratory notebook practices and colleague mentoring
- Solid working experience with various analytical methods like HPLC, dissolution, GC, and general drug substance and drug product compendial analysis
- Experience with method development using techniques like: solid state, PSD, XRPD, NIR, Raman, thermal analysistechniques
- Effectively communicating with analytical technical lead to ensure data is transferred successfully
- Experience in HPLC method development (RPLC, IEC, SEC, Affinity, HILIC, glycan analysis). Hands-on experience with Waters HPLC and UPLC instruments is desired
List of Typical Experience For a Scientist, Analytical Resume
1
Experience For Scientist, Analytical Sciences Resume
- Demonstrated creativity in designing novel solutions to complex technical problems and expertise in development approaches as applicable to area
- Extensive experience and expertise with, but not limited to: HPLC, UPLC, GC, GC/MS, (organic compounds)
- Create effective solutions to complex technical problems. Collaborate with co-workers and customers
- > 5 years relevant work experience
- Experience in Pharmaceutical industry is a pré
2
Experience For Senior Scientist, Analytical Resume
- Mentors, coaches and develops staff and supports capability and skill level improvement
- Contribute to analytical method and validation section of regulatory filings
- Evaluate, develop, validate and implement new technologies in a GMP, regulated environment
- Work with, and provide expert advice to, customers in a strongly collaborative environment
- Provide innovation to Madison/Verona for by proposing, implementing, and championing new analytical technologies
3
Experience For Senior Scientist, Analytical Science Resume
- Perform laboratory testing as needed on R&D projects
- Execute projects and initiatives on time, meeting identified objectives within the targeted budget(s) inside the MilliporeSigma product development process
- Mentor and develop Scientist, Associate Scientist, and Assistant Scientist level analytical scientists via a matrix and/or direct reporting relationship
- Aggressive submission of client proposals following meetings and thorough follow up to drive to a close
- Basic knowledge of laboratory quality and accreditation systems
- Lead analytical efforts for one or more new product development programs
4
Experience For Principal Scientist Analytical & Formulation Development Resume
- Develop test methods for R&D products, intermediates, and raw materials
- Recommend and implement analytical solutions to problems as they arise in R&D
- Operationally qualify, calibrate/verify and maintain analytical R&D equipment
- Establish internal and external presence as analytical expert in conjugates
- Provide qualified technical guidance to reports and/or junior staff members
- Interact well with other functions units (Marketing, Commercial, Process Development, Analytical Development, Technical Operations, Manufacturing, Quality, and Regulatory Affairs) to advance program and department objectives
- Ph.D in Analytical or Organic Chemistry
5
Experience For Senior Scientist, Analytical R&D Resume
- Facilitate communication and relationship between Gilead’s analytical departments and contract sites
- Analytical techniques (e.g., HPLC, CE, ELISA, bioassay, Mass Spectrometry)
- Drive data science opportunities, create compelling scopes of work, and close deals to help the ABC organization meet revenue goals and deliver high quality and high value solutions
- Provide thought leadership, knowledge transfer, technical and industry expertise to internal Teradata teams, strategic partners and clients
- Work with delivery leads and team members to ensure projects are scoped and priced accurately so that they can be delivered accurately, on time, and to high standard expectations
6
Experience For Scientist, Analytical Science Resume
- Collaborate with co-workers and clients to meet goals
- Review and write technical development reports and regulatory documentations
- Communicate with different stakeholders about the project progress
- MSc or PhD with a specialization in Analytical Chemistry
- A real people manager
7
Experience For Data Scientist / Analytical Consultant Resume
- (For the formulation function): Design and execute the formulation development experiments independently
- Provides effective management of the Analytical Science group within a project matrix concept. Manages interfaces, maintains flexibility, and prioritizes workload in order to complete complex and variable projects tasks
- Understanding of method development and validation per ICH regulations
- Understand current regulatory guidelines for production of human recombinant products, including process or method validation
- Ensure continuous improvement and technology leadership and build a stronger IP position for BI
8
Experience For Senior Scientist, Analytical Sciences Resume
- Planning and successful execution of analytical methods to support formulation development and troubleshooting
- Representing Analytical Sciences on internal development teams evaluating new technologies
- Authoring IND, IMPD, and NDA/WMA submissions as well as responses to agency questions
- Ensure worker safety including training, supervision and control of safety guidelines
- Permanent development of a technically & scientifically oriented team to ensure personal development, increase flexibility and improve processes
- Collaborates closely with other Lab Heads, Principle Scientists, Senior Scientists and partners
9
Experience For Scientist, Analytical Technology Resume
- Fosters a flexible true team culture (One PS team) and support others as needed to allow organization to rapidly adapt to the dynamic business environment and changing project portfolios
- Possession of ability to motivate and develop employees
- Present technology and scientific results at international symposia / congresses
- Ensure timely supply of analytical methodologies required to ensure, high quality and safe product to support pre-clinical and clinical studies and commercial manufacturing (including CMO and NBE/Biosimilar projects)
- Knowledge of SixSigma and LEAN are helpful
- Compliance with regulatory authorities, e.g. virus clearance, method qualification, assistance with regulatory dossiers and GMP requirements, safety at work (EHS) and customer relations/visits (internal/clients)
10
Experience For Data Scientist / Analytical Developer Resume
- Expertise in characterization of protein primary structure, post-translational modifications, degradations, identification of process and/or product related variants and impurities with LC-MS such as peptide mapping, intact mass analysis
- Knowledge and broad understanding of the cGMP requirements as they apply to the Biopharmaceutical industry. Good understanding of relevant USP methodologies and ICH guidelines
- Effective and collaborative cross
- Analytical support of small molecule formulation development for both solid and sterile formulations
- Strong collaboration with internal stakeholders
- Author and review validation protocols, reports, SOP’s, deviations, method transfer protocols and reports
- Improve analytical methods, implement new technologies, and perform (re-)validation of methods
List of Typical Skills For a Scientist, Analytical Resume
1
Skills For Scientist, Analytical Sciences Resume
- Excellent oral and written communication skills; demonstrated good presentation skills of scientific material
- Prior leadership or project management experience is highly desirable
- Communication and interpersonal skills to partner with projects and provide technical expertise
- Working knowledge of FDA/EMEA regulations for biologics (Phase I-III and commercial manufacturing) including experience in CMC documentation
- Experience with managing cross-functional projects and project management tools for tracking and communicating progress
- Keen to learn with hands-on experience in coding, passionate to solve technical challenges
- Up to three (3) years’ experience leading employees and projects
- Strong knowledge of laboratory software for data acquisition: Empower, ChemStation, etc. required
- Strong knowledge of USP, GMP, FDA, ICH and other regulatory requirements required
2
Skills For Senior Scientist, Analytical Resume
- Proven ability to develop and implement new analytical methods
- Experience in Analytical lab
- Experience with bispecific antibody development is desirable
- More than 5 years of relevant experience from the biotech or pharmaceutical industry in a GMP environment is preferable
- Experience analyzing metal (aluminum, titanium, nickel) and ceramic matrices, bulk and powder
3
Skills For Senior Scientist, Analytical Science Resume
- MS or Ph.D. in Analytical Chemistry or a related field as well as relevant experience
- Experienced with the analysis of biomolecules biologics assay development/ optimisation and assay qualification
- BS + min. 7 years’ experience in the pharmaceutical analytical chemistry or related sciences, with hands-on knowledge of current analytical techniques OR
- Analytical laboratory experience with B.S
- Analytical laboratory experience with M.S
- Analytical laboratory experience with Ph.D
- 1+year of experience in Inventory Management and / or Shipment role
- Analytical laboratory experience with B.S. required
- Analytical laboratory experience with M.S. required
4
Skills For Principal Scientist Analytical & Formulation Development Resume
- Analytical laboratory experience with Ph.D. required
- MS) or 0-4 years (Ph.D.) of relevant industrial experience in a GMP lab environment
- Strong knowledge of domestic and international regulatory requirements and pharmaceutical manufacturing processes
- Experience with UnicomTM and Assist software
- Demonstrated ability to establish and maintain relationship with co-workers
- Able to operate and thrive in a high-paced, fluid environment
5
Skills For Senior Scientist, Analytical R&D Resume
- Extensive experience in biological mass spectrometry and liquid chromatography
- Hands-on experience in higher order structural elucidation of recombinant proteins by mass spectrometry
- Hands-on experience with software for MS data analysis of proteins
- Extensive experience in proteomics by LC-MS
- Hands-on experience in biological mass spectrometry and liquid chromatography
- Hands-on experience in structure elucidation of recombinant proteins by mass spectrometry
- Hands-on experience with software for proteomics and for MS data analysis of proteins
- Experience with antibody-drug conjugates and knowledge of structural biology and biophysical techniques
- Experience with antibody-drug conjugates (ADC) and knowledge of biophysical techniques
6
Skills For Scientist, Analytical Science Resume
- Experience with formulation development
- Experience in modern liquid chromatography (HPLC/ UPLC)
- Experience with dissolution characterization, method development, and basic statistical analysis
- Understanding core business, products and services
- Understanding industry and industry trends
- Working knowledge of international regulatory guidelines, such as ICH, EP, JP
- Willing to travel abroad a few times a year
- Understanding the various analytic techniques and technologies that can be applied to solving complex business problems
- Capable of training and developing others in an Analytical chemistry lab required
7
Skills For Data Scientist / Analytical Consultant Resume
- Across industries including (but limited to) Finance, Insurance, Health Care, Government, Retail, and Manufacturing
- Knowledge and Understanding of the following techniques
- Keep up to date with external patents and literature; pursue active presentation/publishing and patenting strategies
- Ensure development & transfer of analytical methods for therapeutic biologics to manufacturing or QC, including CMO and NBE/Biosimilar projects
- Interact with QC, analytical development, manufacturing, manufacturing sciences, regulatory and QA
- Capable of providing technical leadership and support to multiple test areas within Analytical Chemistry
8
Skills For Senior Scientist, Analytical Sciences Resume
- Baseline knowledge of alloy systems and additive manufacturing processes
- Process complex data sets using Excel and basic statistical tools
- Through customized solutions in Fraud Detection, Credit Scoring, Cross/Up Sells, Price Elasticity, Quality Control, and more
- Prepare technical reports based on data from multiple analysts utilizing multiple analytical techniques
- Active interest in visualization and story telling
- Builds, develops and maintains a lab with cutting edge expertise and capabilities
- Identify and establish state-of-the-art technologies for analysis (including asset management and strategic investments)
9
Skills For Scientist, Analytical Technology Resume
- Foster an innovative environment/culture in alignment with the line management and Director of BioProcess Engineering
- Thorough knowledge of GMP biotechnology manufacturing
- Conduct analytical activities utilizing analytical methods transferred in from customer or newly developed at center
- Develop and maintain relationships with the regional commercial and marketing teams, as well as the global Fast Trak and R&D organizations
- Knowledge on data audit in order to ensure accuracy of data and analytical processes
- Communicate technical information both verbally and written reports that is understandable to a broad range or recipients, including technical and non-technical audience
- Demonstrated ability to troubleshoot instruments and methods required
- Produce concise and relevant results reports
- Proficient in all aspects of standard, sample and volumetric solution preparation required
10
Skills For Data Scientist / Analytical Developer Resume
- With techniques derived from Predictive Modeling, Forecasting, Econometrics, Optimization, Social Network Analysis, Survival Analysis, Text Mining, Design of Experiments, etc
- Using a wide spectrum of analytic and computational tools such as SAS, R, Python, Perl
- Technical lead on some specific projects
- Technical leader on analytics, technologies and equipment
- Consolidated knowledge on protein chemistry and direct experience on protein analysis by chromatographic, electrophoretic, spectroscopic and mass spectrometry techniques
- Excellent knowledge of analytical development of chromatographic methods, validation, tech transfer and applied statistics
- Responsible for biophysical characterization of proteins
List of Typical Responsibilities For a Scientist, Analytical Resume
1
Responsibilities For Scientist, Analytical Sciences Resume
- Experience of current Good Manufacturing Practice (cGMP)
- Experience developing HCP ELISAs and supporting reagents
- Five or more years’ experience in data analytics and data science with demonstrable successes using quantitative approaches
- Hands on experience with reporting and visualization tools such as Tableau, Qlik, Cognos, others
- Experience with performing characterization work for regulatory submissions and/or the development of methods for application within a QC environment
- Experience authoring IND, IMPD, and/or NDA/WMA submissions
- Performing housekeeping within the Analytical Sciences Laboratories, ensuring safety standards are maintained
2
Responsibilities For Senior Scientist, Analytical Resume
- Ensuring equipment logbooks are kept up to date and filled in using the appropriate guidelines
- Providing training to colleagues in analytical methods, as required
- Working knowledge of analytical techniques including but not limited to
- Writing technical reports for issue to the client or inclusion to support internal Regulatory Submissions
- Training in new analytical methods and training others in techniques/technologies
- Analytical leadership support to drug development and innovative technolgy teams
3
Responsibilities For Senior Scientist, Analytical Science Resume
- Presentation of results to teams and internal governance bodies
- External engagement in analytical technology and regulatory sciences related focus groups, consortia and academia
- Sample reception and check-in in the lab management system
- Perform Wet chemical analysis
- Operations and troubleshooting of High Performance Liquid Chromatography (HPLC), Fourier Transform Infrared Spectroscopy (FT-IR), Laser Diffraction and Spectrophotometer
- Knowledge on calibration and verification procedures and protocols
- Provide technical expertise on analytical methodologies for small molecule drug substance and drug products
- Transfer analytical test methods to QC and contract laboratories
- Author and review transfer protocols/reports and perform statistical data analysis
4
Responsibilities For Principal Scientist Analytical & Formulation Development Resume
- Review and optimize analytical methods to make them robust and simple (suitable for QC) and ensure the methods are in compliance with global regulatory agency guidelines
- Author and/or review analytical method validation protocols/reports prepared by partners according to ICH guidelines
- Trouble-shoot and participate in complex analytical investigations
- Interact with contract laboratories across multiple regulatory markets
- Set up and run analytical test methods in the laboratory and optimize them
- Manage projects across sites, companies and cross-functional areas
5
Responsibilities For Senior Scientist, Analytical R&D Resume
- Use advanced analytical technologies, design, manage, and implement analytical development activities to support all stages of drug development including drug substance and drug product development. Independently manage project timelines
- Develop novel methods to solve challenging analytical problems
- Lead and perform laboratory experiments to demonstrate method suitability for applications to drug substance and drug product development, scale-up and commercialization
- Ensure generation of high quality scientific data
- Lead and actively contribute to transfer of analytical methods to meet project milestones
- Prepare, review and approve analytical data, technical reports and analytical methods for inclusion in relevant sections of INDs and NDAs
- Author relevant sections of INDs and NDAs as required. Respond to agency questions
6
Responsibilities For Scientist, Analytical Science Resume
- Plan, initiate and direct activities at contract labs to ensure quality of work and timely delivery of results
- Direct interaction and effective collaboration with project team members, including presenting data at project team meetings; critical review of data; and active involvement in solving technical challenges that arise during development
- Design, develop and deliver training courses, theoretical as well as practical, in the field of biomanufacturing for both internal and external customers
- Thorough knowledge of biotechnology process development methodologies
- Analytical techniques (e.g. HPLC, CE, ELISA, bioassay, Mass Spectrometry)
7
Responsibilities For Data Scientist / Analytical Consultant Resume
- Develop analytical methods necessary to support process development projects at Fast Trak
- Assess and/or evaluate customer analytical methods and develop as necessary
- Add value to GE’s customers by identifying continuous improvement opportunities in their bio-manufacturing processes and designing and implementing innovative process enhancement
- Maintain accurate and complete records of all work, and report to customers and management in oral and written manner
- Conduct independent scientific application work on key projects
- Develops analytical methods including HPLC, qPCR, Capillary Electrophoresis, Western Blots, ELISAs and general methods such as pH, appearance, UV, etc. Creates written procedures/SOPs and protocols. Transfers, qualifies or validates methods as needed. Mentors staff within a matrix environment when appropriate
- Applies routine and specialized analytical techniques to characterize and quantify biopharmaceuticals and summarizes results in written reports. Complies with Quality Principals related to data generation and reporting
- As appropriate, makes high quality scientific presentations at internal management, regional and national meetings to help advance Allergan’s image as the thought and product leader in the neuromodulator and eye care field
- Serve as a mass spectrometry, biochemistry, and heightened product characterization resource for the department and project teams, proactively keeping colleagues updated with current scientific trends and technical aspects from conferences, local meetings, and the literature
8
Responsibilities For Senior Scientist, Analytical Sciences Resume
- Develop novel strategies and methods with the latest UHPLC and MS technologies for more informative and efficient product characterization and process monitoring
- Experience with top-down MS methodology is highly desired
- Experience with sequence variant and/or host cell protein analysis via LC/MS/MS is highly desired
- Strong collaboration with fellow Analytical Sciences colleagues as well as cross-functional partners
- Experienced in the analysis of biomolecules
- Experience with biologics assay development/ optimisation and assay qualification
- Familiarity with QbD principles and multi-attribute testing is highly desired
- Make scientific presentations both internally and externally, as well as publish manuscripts in peer-reviewed journals
- Specialization in protein mass spectrometry (LC/MS and LC/MS/MS) with working knowledge of modern fragmentation methods (CID, ETD, HCD and/or UVPD) and Thermo Scientific instrumentation is required
9
Responsibilities For Scientist, Analytical Technology Resume
- MS-based method development experience is highly desired for implementing more informative and efficient approaches to product characterization and process monitoring
- Support of investigations with heightened characterization methodologies as appropriate to solve complex issues regarding assay performance, product quality attributes, and drug substance and drug product manufacturing
- Knowledge of protein N- and O-glycosylation with respect to biosynthesis, structure, analysis and function is highly desired
- Accountable for general laboratory upkeep, and instrument maintenance and performance assessments
- Help to troubleshoot the challenges associated with the development of solid and sterile drug products for small molecules, peptides and oligonucleotides through active collaboration with cross functional project teams
10
Responsibilities For Data Scientist / Analytical Developer Resume
- Support the execution of scientific studies to inform the selection of early development and market formulation compositions and manufacturing processes using traditional and advanced analytical technologies
- Document the execution, procedure, results, and conclusions of experiments in a detailed manner
- Develop and implement analytical methods utilized for both formulation development as well as methods for the release and shelf-life assessment of clinical supplies
- Author internal memos, data summaries, and technical reports, and IND/ IMPD submissions
- Support analytical development and characterization of both drug products within the pipleine and innovative technology teams
- Present results of experiments to teams
- Engage the external scientific community through professional organizations, conferences, and external publications
- Extensive working knowledge of characterisation analytical techniques including but not limited to the use of state-of-the-art Mass Spectrometry instrumentation and techniques such as, LC-MS, DLS, CD, SEC-MALLS, icIEF
- Ideally holds practical experience of the following
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