Analytical Development Resume Sample
Zetta Lockman
65373 Sim Inlet,
Houston,
TX
+1 (555) 930 0178
Work Experience
Director, Analytical Development
04/2017
-
PRESENT
Detroit, MI
- An expert at developing and validating test methods for pharmaceutical raw materials and finished products for strength, impurities, identity and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis
- An expert at testing pharmaceutical raw materials and finished products by internally developed and compendial test methods
- An expert at troubleshooting analytical and instrument problems and at performing OOS investigations
- An expert at GMPs as they pertain to an R&D analytical group and pharmaceutical product development
- A strong working knowledge of descriptive organic chemistry
- A working knowledge of pharmaceutical formulations development
- Oversee analytical strategy, planning and execution for Akebia’s overall product development pipeline
- Drive the methods validation strategy and timeline working closely with cross-functional and external partners
- Develop and manage analytical function budget
Mgr, Analytical Development
02/2011
-
10/2016
Houston, TX
- PhD in Analytical Chemistry or related disciplines
- In-depth biotechnology technical experience in protein analytical development for molecules from lead selection to clinical development and commercial launch
- Hands on experience on analytical technologies such as HPLC, CE, peptide map, mass spectrometry, ELISA, and cell-based bioassay is required
- Significant experience with protein characterization and comparability assessment is essential
- Direct experiences on transfer of analytical methods to CMO’s is required
- Extensive experiences on authoring analytical sections for regulatory submissions
- Leadership experience with proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
- Knowledge of cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements
- Assist with one or more of the following
Intern, Analytical Development
04/2008
-
11/2010
Boston, MA
- Represent Analytical Development on program teams
- Develop approaches to negotiation with regulatory agencies of analytical control strategies including specifications and stability for the entire supply chain: from regulatory starting materials to bulk drug substance to formulated drug
- Oversee method transfers and analytical activities at contract organizations worldwide; ensure timely production of drug inventory and compliance
- Establish and manage reference standards and reference materials
- Manage, develop, and hire, as appropriate, a team of Analytical Development scientists
- Author technical reports and protocols
- Provide input and data for regulatory submissions, including writing and reviewing Module 3 analytical content
Education
Kansas Wesleyan University
2002 - 2007
Bachelor's Degree in Chemistry
Professional Skills
- Strong communication skills and diplomacy are required for this leadership position
- Proven success leading analytical development function: strategy, task assignments and monitoring progress, building a network of external partners
- Deep experience leading an Analytical Development function with GMP responsibilities
- B.S., M.S., or PhD. with 5+ years of experience relating to pharmaceutical formulation development and analytical chemistry
- Experience working with clients and internal project teams is required
- CMC and regulatory experience with advancing drug product formulations through later stage clinical trials encouraged
- Design and oversee the development, validation and transfer of phase appropriate analytical methods for raw materials, in-process control, DS and DP testing
How to write Analytical Development Resume
Analytical Development role is responsible for manufacturing, research, software, travel, design, planning, training, health, teaching, leadership.
To write great resume for analytical development job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Analytical Development Resume
The section contact information is important in your 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 Analytical Development Resume
The section work experience is an essential part of your 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 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 analytical development position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Analytical Development resume experience can include:
- Demonstrates strong leadership ability
- Experience in method development, qualification, and validation around common pharmaceutical analytical techniques
- Experience prolonged sitting, standing, some bending, stooping and stretching
- Experience working with 3rd parties and developing/maintaining working relationships with these partners
- Experience in mentoring and developing scientific staff
- Experience in the testing of inhalation products is highly desired
Education on an Analytical Development Resume
Make sure to make education a priority on your 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 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 Analytical Development Resume
When listing skills on your 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 analytical development skills:
- Strong organizational/follow-up and planning skills
- Experience in analytical development. Small Molecule, Early Phase, Solid Oral Dosage product focus experience is highly desired
- Demonstrated CMC experience managing analytical development for small molecule drug substance and drug product
- Demonstrated experience working with US pharmaceutical regulatory submissions
- Experience in method transfer, assay development, SOP development, validation
- Strong background in instrument qualification, experimental design and method validation
List of Typical Experience For an Analytical Development Resume
1
Experience For Director, Analytical Development Resume
- Conduct evaluation of solid state characterization utilizing suitable techniques and evaluate a generic approach for purity testing of macromolecules
- Direct and manage analytical method development and validation at Lexicon’s contract manufacturing organizations
- Demonstrable experience in leading lab-based analytical development team
- Experience of leading cross-functional analytical project teams that set CMC analytical strategy for new medicinal products
- Experience with developing assays for lentiviral and AAV based therapeutics
2
Experience For Mgr, Analytical Development Resume
- Demonstrable experience in leading lab-based team of scientists
- Significant experience in interacting with CROs/CMOs
- Use hand-eye coordination and manual dexterity sufficient to operate a manual pipets and other analytical equipment is required
- Manage a team of experienced analytical development professionals, responsible for drug substance, drug product and QC and hire new staff, as appropriate
- Experience with late phase pharmaceutical products and/or generics is highly desirable
- Working knowledge of CFR 21Part 11
- Administrate the departmental cleaning verification program to support the Pilot Plant and the packaging lines
- Improves efficiency through improving testing processes and implementation of new technology
- Provides coaching, training and mentorship to his/her direct reports and other scientists within the Analytical Development department
3
Experience For Analytical Development Specialist Resume
- He/She participates in the coaching and in the training of AD scientists
- In managing, as a point person, contract development and manufacturing organizations
- Develop analytical controls strategy, oversee planning and execution for Akebia’s overall product development pipeline
- Works cross functionally providing leadership, guidance and support to Operations and Quality
- Write and execute IOPQs for analytical testing equipment
- Participate in the development and revision of product specifications, providing expert level guidance in accord with current regulatory requirements
4
Experience For Manager, Analytical Development Resume
- Student is involved in science program and has an interest in conducting research in analytical chemistry/biochemistry
- Knowledge of QbD approaches to analytical method development including risk assessment, DOE and statistical analysis
- Perform testing of samples as per established test method as part of method qualification/transfer readiness or as part of a commercial investigations
- Manage laboratory equipment upkeep and record keeping
- Sit for long periods to work on a computer
5
Experience For Director, Biologics Analytical Development Resume
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials
- The Associate Director/Director is responsible for co-developing analytical development strategies with the global PDMS in supporting local China R&D projects sited in China, in line with the customer’s expectations, and translating the development strategies into plans in alignment with internal stakeholders and external partners
- The Associate Director/Director is responsible for Implementing and executing of the developed strategies by providing scientific leadership and technical oversight, managing day-to day activities to ensure adherence to timelines and budgets, and improving existing or developing new technologies based on customers’ needs
- Lead end to end development and commercialization of biopharmaceutical large molecules analytical development projects in supporting PDMS activities in China/Asia Pacific
- Share responsibility for the group’s scientific and technical standards, critical review of documentation and reports, and setting analytical strategy to support discovery and product development
- Management / supervisory experience
- Strong familiarity with ICH, GMP guidelines and SOPs
6
Experience For Head of Analytical Development Resume
- Clear evidence of leadership
- Work closely with CMO’s and Analytical SMEs to ensure analytical packages are ready in a timely manner
- Use and maintain equipment in a neat and orderly manner. Report any malfunction immediately to supervisor. Repair minor problems. Maintain service and calibration records in accordance with appropriate SOP’s
- Supervision, training, and development of the Director’s team
- Test stability samples in support of internal product development
- Represent WuXi in relevant regulatory meetings to maintain current knowledge of regulatory standards, assure compliance and identify appropriate analytical tests for development
- Develops and delivers technical presentations for internal and external company seminars and training
- Train laboratory staff on new test methods
7
Experience For Senior Manager, Analytical Development Resume
- Staff, train, and supervise the Investigational and Technical Reports group
- Manage resources to assure timely completion of OOS Investigations and analytical testing reports, which includes compiling, writing, reviewing and approving reports
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures. Conduct employee performance appraisals in a timely and objective manner
- Knowledge in chemistry and ability to operate various analytical instruments (e.g. GC, TOC UVis, Karl Fischer) desired
- Strong familiarity with one or more regulatory agencies (ISO, UPS, ASTM, AAMI)
- Thorough knowledge of experimental design
- Proficient in Microsoft (Excel, Word, Outlook, Power Point)
8
Experience For Senior Director, Analytical Development Resume
- Serve as a subject matter expert in biophysical and/or other physicochemical areas to lead new technology development
- Provide technical advice to analytical scientists and associates, where needed, to assure the highest quality of data is developed and presented
- Author, review and/or approve key documents such as: method development reports, SOPs, validation protocols/reports, comparability protocols and reports, justification of specifications, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.)
- Represent analytical development in verbal and written communications with regulatory agencies, product development teams for all therapeutic areas
- Initiate and lead cross-functional team to develop business processes and guidelines for integrated early and late stage analytical development activities in support of biologics/small molecule commercialization
- Publish/present in high quality journals/conferences
- Advance Amicus scientific and regulatory approaches via active participation and leadership across industry trade groups and conferences
9
Experience For Intern, Analytical Development Resume
- Lead the overall scientific, technical and operational efforts within Analytical Development in regards to physicochemical characterization and analytical methods development
- Establish procedures and protocols that would enable a deeper understanding of the impact of molecular attribute on product safety and efficacy to justify and establish the analytical control strategy
- Further establish internal capabilities and tools for rapid characterization of product quality to enable upstream, downstream, and formulation development and optimization
- Administers performance management program and provides strategic input into the team growth plan
- Collaborates with Quality Assurance and Quality Control on analytical method validation and compliance issues to ensure that high quality standards are maintained and the appropriate documentation is completed
- Supports operational budgets, cost controls and resource planning to meet corporate strategic objectives
- Adhere to development quality systems and standards to ensure data integrity and participate in data reviews and client discussions as needed
- Hire, train, develop, and retain SMEs and manage within company systems
10
Experience For Gstc-analytical Development & Commercialization Intern Resume
- Ensure a safe work environment, processes, and standards
- Experience with analyzing and interpreting common analytical data used for amorphous pharmaceutical applications such as DSC, particle sizing, dissolution, GC, XRPD, HPLC, and KF
- Provides mentoring and technical direction to other members of AD staff
- Where appropriate, oversee and manage the relationship with external CMOs/CROs/ Alliance partners
- Comply with Environmental Health and Safety Requirements
- Contributes to the ownership and advancement of lab instrumentation, work processes, and procedures
List of Typical Skills For an Analytical Development Resume
1
Skills For Director, Analytical Development Resume
- Experience working in a development, GMP and GLP environment as it applies to laboratory and stability functions
- BS/MS/PhD in Chemistry (or relevant discipline) with required years of experience
- Multi-task and prioritize work assignments with little supervision
- Proven abilities in leadership and personnel management
- Knowledge and direct experience with CMC analytical requirements for IND stage drug compounds
- Champion ownership through excellent cost-center management
- Proven success with US and international regulatory approvals
- Ph.D. in analytical chemistry or related subject with over 15 years industrial experience
- Manage daily activity of direct reports to define, develop, and validate analytical methods
2
Skills For Mgr, Analytical Development Resume
- Adopting and driving innovative analytical techniques and strategies that translate into robust commercial analytical testing platforms
- Provide scientific guidance (including beyond analytical chemistry), leadership, and training to others within the department
- Thorough understanding of the regulatory requirements in CMC development
- Perform one or more biochemical assays, SDS-PAGE, Western blotting, HPLC, ELISA, molecular assays such as PCR
- Clearly communicate in writing and verbally with internal staff as well as clients
- Communicates within the larger organization and external community, providing expert guidance to multi-disciplinary teams and senior management
3
Skills For Analytical Development Specialist Resume
- Fosters a culture of high performance and excellence in everything we do
- Development of Module 3 analytical content in collaboration with Regulatory Affairs CMC, serving as the analytical lead for associated regulatory interactions
- Demonstration of driving analytical innovation
- Construct standard operating procedures (SOPs) to outline newly created workflows
- Be approachable, self-motivated, adaptable and manage setbacks with a positive attitude
- Work independently under minimal supervision and as part of a collaborative team
- Understands and applies advanced scientific principles, theories, concepts, practices and standards to process and product development
- Fluency in synthetic chemistry, drug substance processing, formulation development, pharmaceutical processing with a deep understanding of pharmaceutical sciences related to drug product development
- Mastery of chemistry with extensive expertise in measurement science
4
Skills For Manager, Analytical Development Resume
- Understands drug development and works to build CMC dossier for regulatory submissions as an author/reviewer
- Sound Judgement and ability to negotiate and resolve issues related to complex scientific, regulatory, and compliance challenges
- Scientific knowledge and experience in analytical/organic chemistry in drug development and associated analytical requirements throughout the discovery/development/commercial continuum. Maintains current awareness in areas of expertise
- Thorough knowledge of cGMP/GLPs in the pharmaceutical industry
- Excellent written and communication skills to effectively represent the analytical issues with internal project and CMC teams, external contract organizations and senior management
- Creates an impactful vision for the analytical function and communicates a supporting strategy to align people, resources and management within their department, cross-functionally, and at CROs or other partner organizations
- Encourages new ideas, approaches and processes
- Learn new techniques and keep accurate lab records; the ability to work independently and as part of a team
5
Skills For Director, Biologics Analytical Development Resume
- Learn new techniques and keep accurate lab records
- Flexible to work on multiple projects
- Reviews work for technical soundness and accuracy
- Perform one or more biochemical assays, such as PCR and, and/or Gel Electrophoresis
- Exceptional verbal and written communication skills and interpersonal skills as a team member/leader in an environment where individual initiative, collaboration and accountability are valued
- An expert related to cGLP/cGMP and applicable FDA, EMA and ICH guidance
- Mastery of USP and other compendia and how they guide drug development decisions
- Works independently and is a leader in the department
6
Skills For Head of Analytical Development Resume
- Significant and long-term impact on overall company performance
- Fluent in MS Project and related project management tools
- Expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive)
- Excellent verbal & written communication skills, with the ability to effectively present to and influence different functional groups across all levels of the organization
- Able to communicate effectively with clients regarding project scope, scientific results and project updates, including unexpected or negative results and potential delays
- Desire to be a part of a highly innovative company with a focus on Patient First values
7
Skills For Senior Manager, Analytical Development Resume
- Phase appropriate analytical method development and validation for small molecules and synthetic peptides, immediate release and modified release solid oral dosage forms, including solubilization technologies
- Drive innovative approaches to the development, evaluation, and negotiation with regulatory agencies of analytical control strategies including specifications and stability
- Establishment and management of associated reference standards and reference materials
- Development of phase appropriate, risk-based quality systems in collaboration with Quality
- Recruit, develop, and mentor the analytical team to meet current and future program, department, and individual goals
- Create and provide appropriate technical methods, procedures, guidance, and systems
- Schedule work across multiple projects to meet deliverables and ensure adequate scientific staff capacity to meet project demand
8
Skills For Senior Director, Analytical Development Resume
- Assist and support GMP manufacturing by participating in activities, including, but not limited to: development study design and execution, training, clinical tech transfer, investigation support, product commercialization and ongoing product support, equipment design and qualification, and change control
- Act as a technical mentor for direct reports and more junior Research Chemists and Engineers
- Accountable for the technical quality of project deliverables to ensure client relationship success through work executed by the Project Lead, Project Manager, and subject matter experts
- Identify and execute continuous improvement opportunities on specific technology platforms to maintain ‘world class’ technical line capabilities that attract and retain clients
- Experience with typical analytical techniques and regulatory requirements for characterization of drug product, including dissolution, disintegration etc
- Demonstrate a high level of professional expertise in one or more technical areas
- Experience in a quality control lab is highly desirable
- Demonstrated ability to work successfully in a highly collaborative, team oriented, and customer focused environment
9
Skills For Intern, Analytical Development Resume
- A BS with documented experience of analytical work for 1-3 years in a biologics industry laboratory
- Of time: Documentation including data analysis, summarizing data and documenting results
- Review quality control documentation, including stability studies, in support of drug substance manufacturing at contract manufacturing organizations
- Act as a consultant to project teams when defining pricing strategy and budget
- Manage analytical experimental design, execution and writing testing methods and qualification protocols/reports
- Of Time: Training and presenting data
10
Skills For Gstc-analytical Development & Commercialization Intern Resume
- Key member of the Manufacturing Sciences leadership team to assess and support CMC strategy
- Works closely with colleagues in manufacturing sciences to ensure timely analytical support for cell line, process and formulation development
- Review and approve qualification reports and QC SOPs; address testing related issues at CMO’s in collaboration with Quality
- Manage analytical resources and strategic planning to support early and late stage projects
- Build and lead an analytical method development team comprising of 5-6 direct reports that are focussed on cell analytics
- Proactive, critical analysis of technical and non-technical problems, taking appropriate actions for resolution
List of Typical Responsibilities For an Analytical Development Resume
1
Responsibilities For Director, Analytical Development Resume
- Experience with Microsoft Office and other typical computer software associated with modern analytical development
- Effective communication with all levels of the JM organization, as well as with third party partners and vendors
- Financial Management of External Studies
- Lead analytical team to develop physiochemical and functional assays to support process and product development as well as product release
- Oversee comparability strategies and CQA assessments
- Stay current with protein analytics and introduce new technology to enhance workflow and capabilities
2
Responsibilities For Mgr, Analytical Development Resume
- Co-chair specification committee and lead establishment of specifications for drug substance and drug products
- Provide supervision for assay transfer and oversee CMO activities
- Manage reference standards and oversee critical reagent strategy
- Act as a mentor for the junior staff and emphasize best practices
- Partner with QA and Regulatory to support batch releases and regulatory submissions
- Of time: Execution of experimental studies
- Provide analytical oversight of external vendors for Generic API and finished dose CMC analytical activities for small molecule drug substance (DS) and drug product (DP)
- Select and manage providers of analytical services, including analytical services embedded in contract manufacturing organizations (CMOs)
3
Responsibilities For Analytical Development Specialist Resume
- Draft and review CMC sections of regulatory submissions along with other functional groups. Participate in preparation of responses to regulatory agency questions
- Familiarity with a full range of analytical techniques for characterization of pharmaceuticals including HPLC & GC with a variety of detection methods, wet chemical analysis, spectroscopic techniques, particle size analysis
- Understand chemical development, solid state development, and formulation development to identify and document critical factors that impact method performance and/or analytical development activities
- Timely monitoring and evaluation of release and stability data from CMOs and CROs for GMP compliance, potential out of specification, out of trend, and method performance issues and supervise or conduct investigations and implement corrective actions as needed
- Actively contribute to program teams, and ensure alignment of analytical activities with the program development plans
4
Responsibilities For Manager, Analytical Development Resume
- Experience with a broad range of analytical techniques and regulatory requirements for characterization of pharmaceutical drug substance including HPLC & GC with a variety of detection methods, spectroscopic techniques, particle size analysis
- Experience with EU/ROW submissions is desirable
- Strategically plan, organize and manage multiple projects simultaneously
- Positively resolve conflict
- Read, analyse, and interpret English-language chemical periodicals, scientific journals, and regulatory documents
- Write clear and concise technical reports and other business correspondence
- AD Specialist ensures the daily follow-up of Analytical Development projects assigned to him/her and keeps the AD Manager and the Pharmaceutical Project Manager informed of the progress of the operations for which he/she is responsible
- He/She conducts the development, validation and transfer of analytical methods according to customer and/or internal requirements and carries out analytical studies and analytical testing activities for the projects for which he/she is responsible
5
Responsibilities For Director, Biologics Analytical Development Resume
- He/She drafts the documents (protocols, reports) for the development, validation and transfer of analytical methods for the projects for which he/she is responsible
- He/She ensures the follow-up of stability programs (storage and analytical testing) for the projects for which he/she is responsible and drafts the corresponding protocols and reports
- He/She ensures the communication of the analytical results to the clients within the given deadlines by using an appropriate format (for example: presentation, report) in collaboration with the Pharmaceutical Project Manager
- He/She participates in setting up new equipment in the Analytical Development Laboratory and in writing the associated documentation (procedures, work instructions, logbooks, etc.)
- Obtain hands on experience in the characterization of macromolecules (polymers and polypeptides) in a pharmaceutical analysis setting
- Age prior to the scheduled start date
- Understand the macromolecules behavior and generate basic platform knowledge to allow the following
- Significant knowledge and expertise in the field of analytical chemistry and scientific methodology is therefore required
- Awareness of EHS and Quality/Regulatory requirements (cGMP) is important, along with written and verbal
6
Responsibilities For Head of Analytical Development Resume
- Generate solubility data in different buffers and organic solvents
- Generate compatibility studies with proposed variety of excipients
- Cumulative 3.0 GPA or above; college transcript required
- Pass a drug screen and background check (within 30 days of target start date)
- Manage and oversee external vendors, serving as primary contact for all activities related to raw materials, in-process, DS/DP lot release testing, analytical method transfers and analytical method validation
7
Responsibilities For Senior Manager, Analytical Development Resume
- Manage and oversee the stability program for all Insmed’s development programs and apply statistical analysis for interpretation of analytical and stability data. Serves as point person for stability software and LIMS (Laboratory Information Management System) / IT Systems
- Experience writing SOP’s laboratory investigations, out-of-specification and deviation reports, CAPA’s, change controls, and annual product reviews
- Author and/or review the development, qualification, validation and transfer of documents
- Experience in ‘head of quality control’ role
- Experience in analytical method development
8
Responsibilities For Senior Director, Analytical Development Resume
- Experience of vaccine, biopharmaceutical or cell and gene therapy product development
- Experience in CMC analytical development in support of recombinant viral vector production, stem cell and T-cell therapies
- Experience in analytical method development
- Commercial process validation and related analytical/QC activities
- Execution of analytical methods validations
- Knowledge of oral solid dose drug product formulation
- Support manufacturing investigations. Participate in review and peer proofing activities within and between departments
- Identify problems, understand potential sources of error, and perform troubleshooting where necessary
9
Responsibilities For Intern, Analytical Development Resume
- Currently in Sophomore or Junior level curriculum, working toward BS or BA in Chemistry or Biochemistry
- Lead incident/OOS investigations ensuring that the investigation is thorough and completed in a timely manner. Interact with QA to ensure closure of compliance gaps
- Contribute to documents for regulatory filings
- Basic understanding of mechanical systems and electronics, in order to communicate effectively with environmental chamber and monitoring equipment maintenance and metrology personnel
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and Adobe
10
Responsibilities For Gstc-analytical Development & Commercialization Intern Resume
- BS in biology, cell biology, virology, biochemistry or related scientific discipline
- Demonstrable capability in innovation with application of new/high throughput analytical techniques
- Documents data accurately and completely as per established company guidelines and SOPs
- Contributes to technical documents such as test methods, reports, protocols, and internal presentations
- Contributes as part of a small team of scientists towards the optimization, qualification and technical transfer of analytical methods to be used in support of biological therapeutic product release and characterization testing in a compliance-based environment in a timely manner to meet program and company timelines
- Applies technical knowledge under minimal supervision to execute method qualification and transfer activities
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