Job Summary:

• Accountable for running and maintaining the analytical lab analysis and any equipment used.
• Interact with other technicians and scientists and may supervise the analytical testing work of backup technicians
• Assure compliance of data generated with all regulatory requirements including understanding and following Good Laboratory Practices (GLP).
• Able to develop knowledge and solve problems for the improvement of products and the testing of these products as part of a team.
• Plan, conduct and document analytical testing of developmental and finished products.
• Ensure proper operation and maintenance of laboratory equipment and processes.
• Maintain all current testing methods to ensure they are compliant with food and pharmaceutical compendia.
• Complete and execute testing method validations and equivalency testing as dictated by the finished product regulatory environment.
• Responsible for directing laboratory safety and housekeeping activities according to Huber policies.
• Develop and maintain all lab equipment, records, and methods to ensure GLP and GMP compliance.
• Ensure set-up and calibration of new and existing equipment.
• Maintain laboratory equipment and consumable stock levels.

Skills on Resume:

• Analytical Lab Management (Hard Skills)
• Team Collaboration (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Problem Solving (Soft Skills)
• Analytical Testing (Hard Skills)
• Equipment Maintenance (Hard Skills)
• Method Development and Validation (Hard Skills)
• Safety and Compliance (Soft Skills)

Job Summary:

• Perform Host Cell Protein testing using ELISA with Molecular Devices’ M5 plate reader with SoftMax software
• Analyze data using MS Excel
• Use Electronic notebook to document experiments
• Save experiment data in ECM (OpenLab)
• Enter results in LIMS
• Write summary reports on cumulative assay data per client’s requests
• Prepare presentations using MS PowerPoints
• Communicate effectively with internal stakeholders and clients
• Update technical documents
• Demonstrate the ability to work in a team environment
• Support Quality Assurance efforts within the Analytical Sciences department

Skills on Resume:

• MS Excel Data Analysis (Hard Skills)
• Electronic Notebook Proficiency (Hard Skills)
• ECM (OpenLab) Data Management (Hard Skills)
• LIMS Data Entry (Hard Skills)
• Summary Report Writing (Hard Skills)
• PowerPoint Presentation (Hard Skills)
• Effective Communication (Soft Skills)
• Technical Document Updating (Hard Skills)

Job Summary:

• Develop and validate methods
• Provide analytical support to the research and development group to meet project goals
• Select appropriate methods and techniques in performing experiments
• Collaborate with analytical personnel to help develop routine analytical methods
• Work cross functionally to achieve target goals and proactively seek out potential solutions to issues.
• Assist in creating method validation and/or qualification protocols and reports as well as analytical methods
• Perform all lab work that will support method validation, transfer, and qualification
• Perform qualification of primary and secondary reference material to be used as analytical standards.
• Develop, validate and report analytical methodology and, where appropriate, provide resolution to technical problems
• Apply analytical methodologies during the quality control and stability evaluation of a range of materials
• Prepare work protocols for approval, critically assess data generated and review data from peers
• Prepare and review reports, quality documents and training documentation
• Acquire/record data in a manner that complies with GxP and internal policies/procedures
• Perform assigned roles within CMC such as equipment responsible operator, training, equipment hardware and/or software validation and the ordering of consumable items
• Work with due regard to health and safety of self and others
• Work flexibly across the site to meet business needs

Skills on Resume:

• Analytical Method Dev. & Validation (Hard Skills)
• Collaboration & Cross-functional Work (Soft Skills)
• Laboratory Expertise (Hard Skills)
• Problem Solving (Soft Skills)
• Documentation & Reporting (Hard Skills)
• Compliance (Hard Skills)
• CMC Responsibilities (Hard Skills)
• Health and Safety (Soft Skills)

Job Summary:

• Accountable for compliance with all GLP requirements, including timely study and project reporting. 
• Ensuring that associated laboratory equipment and instrumentation is calibrated and maintained in a GLP compliant state. 
• Follow all Standard Operating Procedures whilst observing the safety policies of the company and the laboratory at all times.
• Responsible for performing routine laboratory procedures and measurements which includes sample preparation, chemical and physical testing of products and processing of results obtained.
• Projects are conducted to a standard process to ensure conclusions drawn are accurate to support product registrations or marketing needs.
• Contribute to the development, optimisation and validation of analytical methods and participate in validation/qualification of laboratory equipment as necessary.
• Perform all laboratory functions, when required, such as daily performance checks, preparation of reagents, ordering, organizing laboratory deliveries, washing glassware, laboratory cleaning, routine maintenance etc. whilst maintaining all quality and safety standards.
• Good documentation practices are mandatory, meticulous recording of all experimental work is required.

Skills on Resume:

• Compliance Management (Hard Skills)
• Equipment Management (Hard Skills)
• Adherence to SOPs (Hard Skills)
• Laboratory Procedures (Hard Skills)
• Project Management (Hard Skills)
• Analytical Method Development (Hard Skills)
• Versatility in Laboratory Functions (Hard Skills)
• Documentation and Record Keeping (Hard Skills)

Job Summary:

• Develops, tests, validates, transfers, and approves new test methods and procedures for chemical and instrumental methodology to ensure accuracy and consistency
• Troubleshoot existing methods to ensure efficiency and suitability
• Inspects equipment for calibration and reliability and is responsible for maintaining a safe work environment.
• Directs and performs method validation studies and qualifies installation of new analytical instrumentation.
• Develops stability-indicating test methods and protocols to support new product development and performs appropriate accelerated stability studies and reports results to internal clients.
• Conducts research into state-of-the-art analytical methods through a search of journals and trade publications.
• Presents and report data, finding, project status to management and or to the scientific community. 
• Develop, validate and implement new and improved methods of chemical analysis.
• Perform routine &amp, non-routine chemical analysis using GC, GCMS, HPLC, LCMS, and other analytical equipment.
• Oversee the technical transfer of methods between laboratories.
• Develop, write and update SOP as required.
• Conduct biochemical and enzymatic assay with high throughput format.
• Data entry, processing, analysis and management.

Skills on Resume:

• Test Method Development (Hard Skills)
• Method Troubleshooting (Hard Skills)
• Equipment Maintenance (Hard Skills)
• Method Validation & Instrumentation (Hard Skills)
• Stability Testing & Protocol Development (Hard Skills)
• Analytical Methods Research (Hard Skills)
• Data Presentation & Reporting (Soft Skills)
• Method Improvement (Hard Skills)

Job Summary:

• Independently plan and execute validation studies for test methods
• Implement and perform analytical method transfer to Quality Control Department
• Write validation protocols and final reports, test methods, standard operating procedures, and technical reports
• Under minimal supervision, conduct and document investigations related to validation activities
• Contribute to GMP systems improvement
• Routinely work with hazardous materials and manage hazardous waste in a satellite
• accumulation area
• Develop and maintain in-depth understanding of the scientific principles associated with analytical methods being developed, optimized, transferred, validated, and qualified
• Help with the reconstruction unknown fragrances based on analytical, olfaction and supplementary data
• Carry out analyses on known fragrances in and delivered by consumer products, especially in fabric care applications
• Equipment maintenance and troubleshooting
• Organize Olfactive evaluations

Skills on Resume:

• Analytical Method Validation (Hard Skills)
• Method Transfer (Hard Skills)
• Documentation Skills (Hard Skills)
• Problem Solving (Hard Skills)
• GMP Compliance (Hard Skills)
• Hazardous Materials Management (Hard Skills)
• Scientific Understanding (Hard Skills)
• Fragrance Analysis (Hard Skills)

Job Summary:

• Perform a range of assigned research experiments as directed by the Team Leader Analytical Services
• Be responsible for, and troubleshoot & maintain Analytical equipment
• Interpret experimental data and highlight any interesting or unexpected results
• Contribute to the design of experimental procedures and exercise technical judgement in the execution of these
• Report experiments accurately and promptly. 
• Keep laboratory notebooks up to date in accordance with the company's quality procedures. 
• Write high quality reports for submission to customers and communicate results at internal project meetings and externally to customers
• Consistently monitor analytical techniques for process improvement ideas and new techniques and implement any actions as a result
• To develop dissolution methodology that will provide some measure of an in vivo / in vitro relationship and serve as a quality control procedure.
• To design and execute of studies to ascertain degradation mechanisms in the solution and solid state.
• Assessment of process changes on the quality and the stability of Drug Products, intermediates and APIs, recording the impact of the changes on the impurity profiles.
• To assess stability risks by evaluating process changes and impact on degradation chemistry or dissolution profile, for example, using DoEs and accelerated stability studies.
• To transfer analytical methods to other laboratories and remote sites.
• To develop and support Process Analytical Technology (PAT) techniques.

Skills on Resume:

• Research Experimentation (Hard Skills)
• Analytical Equipment Maintenance (Hard Skills)
• Data Interpretation (Hard Skills)
• Experimental Design and Judgment (Hard Skills)
• Documentation and Reporting (Hard Skills)
• Process Improvement (Hard Skills)
• Methodology Development (Hard Skills)
• Quality Control and Stability Assessment (Hard Skills)

Job Summary:

• Working with multiple Teams in process/product development, identifying appropriate analytical tests to achieve program objectives, specifying test equipment requirements, coordinating acquisition of equipment and installation, developing test methods and procedures, determining test capabilities, and training and support lab technicians.
• Ensure the product development and production support groups follow proper chemical hygiene protocol.
• Coordinate and assist with analytical equipment maintenance both in production support and product development areas.
• Work with production engineers and shop floor personnel to support troubleshooting of production problems.
• Coordinate and maintain raw materials specifications.
• Occasional lead for a new product program in Product Development group
• Identify and maintain access to external resources to make available state-of-the-art analytical capability to the Research and Development team
• Evaluate new approaches, instrumentation or analytical technologies and mentor others.
• Develop and validate analytical methods using Inductively Coupled Plasma (ICP-MS, ICP-OES), X-ray fluorescence (XRF), Scanning Electron Microscopy (SEM, SEM-EDS), and other material characterization techniques.
• Define and build best practices in material sampling, sample preparation, instrumental analysis, data analysis, and result reporting.
• Coordinate & implement cross-functional experiments with research, process engineering, & quality teams.
• Write and review Standard Operating Procedures (SOPs), train cross-functional teams
• Prepare reports and present technical data to engineering and quality teams.

Skills on Resume:

• Project Management (Hard Skills)
• Analytical Testing (Hard Skills)
• Equipment Management (Hard Skills)
• Chemical Hygiene and Safety (Hard Skills)
• Troubleshooting (Hard Skills)
• Raw Materials Management (Hard Skills)
• Leadership and Mentoring (Soft Skills)
• Documentation and Communication (Soft Skills)

Job Summary:

• Provide technical leadership and problem solving in energy transition using advanced analytical and characterization techniques (e.g. chromatography, optical spectroscopy, mass spectrometry, elemental analysis, NMR)
• Advance research and develop new analytical technologies and methodologies to solve complex technical and scientific problems with creative and independent scientific thinking
• Independently drive and lead scientific, strategic, and operational aspects of studies to completion
• Develop advanced analytical methodology, characterization protocol and data analysis strategy to enable R&D and deploy analytical tools to support business
• Utilize analytical capabilities to advance research program by meeting key program deliverables
• Provide technical expertise in supporting established test methods as test method owner
• Contribute to publications by conducting independent research and collaboratively working within multidisciplinary matrix environment
• Operate effectively in a multidisciplinary matrix research environment, providing leadership and insight in the discipline
• Demands a significant experience of interacting with both internal and external collaborators
• Remain current in the field of analytical scienes through literature, scientific meetings, and seminars
• Prepare written, verbal, and visual materials for internal presentations and external scientific meetings
• Familiarity with analysis of biological materials, such as algae, cellulose, and their conversion products is a plus

Skills on Resume:

• Advanced Analytical Techniques (Hard Skills)
• Research and Development (Hard Skills)
• Scientific Problem-Solving (Hard Skills)
• Project Management (Hard Skills)
• Methodology Development (Hard Skills)
• Test Method Ownership (Hard Skills)
• Multidisciplinary Collaboration (Soft Skills)
• Communication and Publication (Soft Skills)

Job Summary:

• Perform routine analysis to support internal and external projects
• Optimise existing analytical methods and develop new methods for analysis of novel formulations
• Verify the suitability of new methods by performing validation studies
• Record analysis contemporaneously in a laboratory notebook
• Peer review analytical data to confirm data integrity
• Peer review laboratory notebooks to ensure quality standards are maintained
• Deliver comprehensive and concise analytical protocols and technical reports
• Perform all activities in compliance with quality standards and to agreed timelines
• Lead analytical activities for internal and external projects as required
• Work collaboratively with Formulation and Process Development Scientists to ensure project goals are achieved
• Technically support the more junior team members
• Maintain H&S standards
• Maintain quality standards

Skills on Resume:

• Analytical Skills (Hard Skills)
• Documentation and Record Keeping (Hard Skills)
• Compliance and Quality Assurance (Hard Skills)
• Project Management (Hard Skills)
• Leadership and Collaboration (Hard Skills)
• Health and Safety (Hard Skills)
• Technical Support (Hard Skills)
• Continuous Improvement and Mentorship (Soft Skills)

Job Summary:

• Develop, validate and report analytical methodology and, where appropriate, provide resolution to technical problems
• Apply analytical methodologies during the quality control and stability evaluation of a range of materials
• Prepare work protocols for approval, critically assess data generated and review data from peers
• Prepare and review reports, quality documents and training documentation
• Acquire/record data in a manner that complies with GxP and internal policies/procedures
• Working shift patterns in order to maintain support to production.
• Perform assigned roles within CMC such as equipment responsible operator, training, equipment hardware and/or software validation and the ordering of consumable items
• Work with due regard to health and safety of self and others
• Work flexibly across the site to meet business needs
• Support the development next generation medicine manufacturing platforms
• Conduct routine analysis of raw materials, intermediates, and final products
• Working on the development and implementation of analytics onto manufacturing platforms that can produce FDA-approved drugs
• Work as a team with mechanical engineers
• Create new smart sensing capabilities

Skills on Resume:

• Analytical Methodology (Hard Skills)
• Quality Control (Hard Skills)
• Documentation (Hard Skills)
• Compliance (Hard Skills)
• Flexibility (Soft Skills)
• CMC Responsibilities (Hard Skills)
• Safety Awareness (Soft Skills)
• Collaboration (Soft Skills)

Job Summary:

• Prepare, aliquot and qualify reagents and reference materials in support of critical reagents and reference standard used in QC assays.
• Write critical reagent qualification protocols and reports.
• Keep detailed notebooks in compliance with SOP and policy.
• Participate in method development, optimization, and validation studies and method transfer to testing sites.
• Write method development report and draft method-specific SOPs.
• Write validation protocols and reports.
• Assist with critical reagents and reference material inventory management and shipment.
• Test QC samples and provide support to QC investigations.
• Trend assay performance and system controls as a measure of reagent and standard stability.
• Oversee instrument maintenance and logbooks.
• Detail oriented, well-organized, and capable of delivering on work assignments of moderate scope, given general instructions, where analysis involving multiple factors is required.
• Effective written and oral communication skills.
• Ability to work efficiently in a GMP environment while exercising judgement within defined procedures/practices to determine appropriate action.

Skills on Resume:

• Reagent and Reference Material Handling (Hard Skills)
• Protocol Development and Documentation (Hard Skills)
• Documentation Compliance (Hard Skills)
• Method Development and Optimization (Hard Skills)
• Validation Protocols and Reports (Hard Skills)
• Inventory Management (Hard Skills)
• QC Sample Testing and Investigation Support (Hard Skills)
• Data Analysis and Communication (Hard Skills)

Job Summary:

• Lead the development and implementation of analytical test methods used in the formulation and ongoing production of molded pharmaceutical dosage forms and combination products
• Conduct routine and non-routine assay, content uniformity, and dissolution testing of experimental and commercial products using HPLC and related methods, including preparation of standards and test samples.
• Lead method transfers from customer and contract labs.
• Research and troubleshoot new test methods and improve/revise standard operating procedures and working practices.
• Perform statistical analysis of data against target specifications to evaluate present standards and achieve required quality and repeatability.
• Prepare reports suitable for internal use and reporting to customers
• QC Lab testing support of R&D and operations in resolving formulation and production issues.
• Participate in root cause investigations and present findings and possible corrective actions for out-of-specification QA/R&D test results.
• Lead and coordinate work with outside labs on non-routine chemical testing. 
• Prepare test requests, review and approve results based on specifications.
• Perform analysis/justification for equipment and other technology purchases including equipment onboarding with authoring and execution of IQ/OQ/PQ 
• Coordinate and review work of junior analytical scientists, providing mentoring and training where needed

Skills on Resume:

• Research and Troubleshooting (Hard Skills)
• Statistical Analysis (Hard Skills)
• Report Preparation (Hard Skills)
• Problem Resolution Support (Hard Skills)
• Root Cause Investigations (Hard Skills)
• Project Coordination (Hard Skills)
• Equipment Analysis and Onboarding (Hard Skills)
• Leadership and Mentorship (Soft Skills)

Job Summary:

• Carry out a range of analysis using ICP, ICP-OES, ICP-MS and XRPD.
• Conduct analysis on a large range of samples covering characterisation and elemental analysis.
• Troubleshoot analytical methods and instrumentation.
• Ensure all equipment and instrumentation is well maintained and validated.
• Provide timely project updates to managers and customers.
• Perform physical and chemical tests on raw materials, active pharmaceutical ingredients, in-process, and finished products using various wet chemical, physical and instrumental techniques.
• Write, and review and revise test procedures, SOPs, technical protocols/reports, ANDA submission and other documents.
• Perform maintenance and calibrations of the laboratory instruments.
• Perform troubleshooting and investigations on routing QC testing, method development, method verification and method validation activities.
• Prepare drug product stability protocols and reports. Evaluate the stability data and trends.
• Coordinate with production and product development group for sample testing and delivery for routine QC and development samples.
• Collect and perform water samples testing for chemical attributes.

Skills on Resume:

• Analytical Techniques Proficiency (Hard Skills)
• Method Troubleshooting (Hard Skills)
• Equipment Maintenance and Validation (Hard Skills)
• Project Updates Communication (Soft Skills)
• Documentation and Compliance (Hard Skills)
• Laboratory Instrument Maintenance (Hard Skills)
• Troubleshooting and Investigation (Hard Skills)
• Stability Testing and Data Evaluation (Hard Skills)

Job Summary:

• Develop, optimize and validate assays into SOPs and establish assay performance and parameters 
• Characterize cell product health and stability after freeze-thaw cycle to optimize freezing protocols
• Work within and across project team to support team members
• Maintain an accurate and updated laboratory notebook
• Compliance with GLP and EHS protocols
• Present data and help prepare reports, presentations and tech transfer documents
• Accomplishing numerous analytical characterizations in Quality Control
• Working in industrialization by performing in-process analytics, intermediate purity analysis, impurity profile analysis and specification settings
• Conducting research and method development for HPLC, LC-MS, GC, anions and solvent residues
• Ensure regulatory compliance for cosmetic, food and intermediate compounds
• Screening everyday analytics
• Preparing analytical samples
• Performing instrument/process validation
• Communicate and collaborate with external analytical CRO’s

Skills on Resume:

• Assay Development and Optimization (Hard Skills)
• Cell Product Characterization (Hard Skills)
• Team Collaboration (Soft Skills)
• Documentation (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Data Presentation and Reporting (Hard Skills)
• Regulatory Affairs Knowledge (Hard Skills)
• CRO Collaboration (Soft Skills)

Job Summary:

• Perform all lab functions under cGMP and ISO 13485 guidelines and PMI Quality Policy.
• Able to help develop new test methods and perform validations.
• Able to perform all technical functions including Quality Control release type testing, customer, analyses, and other requested tests.
• Troubleshoots and provides resolution to testing and lab issues.
• Able to perform unbiased, in-process and finished goods testing according to standardized procedures as required to support product realization.
• Provides data review of lab results as requested.
• Responsible for PM, calibration, and proper maintenance of some or all analytical equipment in lab.
• Train and provide mentorship to Technicians.
• Write testing reports, TMs, and/or SOPs as assigned by the supervisor or manager.
• Able to install and qualify analytical equipment.
• Helps with or responsible for lab planning, organization, 5S, validation activities.
• Contribute to the development of regulatory documents in support of global submissions (INDs, IMPDs, NDAs, briefing packages, etc.).
• Innovate using new technologies to expedite decrease drug development time.
• Create processes to support stability studies management and analytical standards across programs.

Skills on Resume:

• Compliance Knowledge (Hard Skills)
• Method Development (Hard Skills)
• Technical Proficiency (Hard Skills)
• Data Analysis (Hard Skills)
• Equipment Management (Hard Skills)
• Training & Mentorship (Soft Skills)
• Documentation (Hard Skills)
• Planning & Organization (Soft Skills)

Job Summary:

• Generate study plans, protocols and standard operating procedures relating to customer analytical projects.
• Ensure clear and complete documentations of all activities across all areas of responsibility.
• Set clearly defined goals/objectives to ensure schedules are maintained
• Technology transfer activities
• Perform independent data recording, analysis and troubleshooting.
• Document analytical work and results in concise reports and provide project updates in written and oral presentations
• Execute process continuous improvement activities aimed at providing robustness, capacity and efficiency.
• Maintain a high level of interaction and collaboration with the upstream and downstream teams to effectively prioritise samples
• Provide technical support, training and audits to internal and external collaborators.
• Contribute to a safe, clean and effective lab environment with personal accountability

Skills on Resume:

• Project Management (Hard Skills)
• Documentation (Hard Skills)
• Technical Expertise (Hard Skills)
• Communication (Soft Skills)
• Continuous Improvement (Hard Skills)
• Collaboration (Soft Skills)
• Training and Support (Hard Skills)
• Safety and Compliance (Soft Skills)

Job Summary:

• Applying the most relevant sample preparation techniques to provide the most appropriate extract for analysis
• Selecting the most suitable analysis methodology to obtain the required information for stakeholders
• Interpretation and reporting of complex analytical data within agreed deadlines
• Accurately recording data in accordance to guidelines
• Communicate with stakeholders on analysis progress and inform of any potential delays or issues
• Provide support in the investigation of quality control issues and product troubleshooting
• Identify and investigate new developments and techniques in flavour analysis
• Work in a safe manner in accordance with environmental, health and safety policies
• Support analytical method development and validation
• Perform routine maintenance of analytical equipment
• Keeping up to date with scientific and technical developments

Skills on Resume:

• Sample Preparation Techniques (Hard Skills)
• Analysis Methodology Selection (Hard Skills)
• Data Interpretation and Reporting (Hard Skills)
• Accurate Data Recording (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Quality Control Support (Hard Skills)
• Research and Innovation (Hard Skills)
• Safety Compliance (Hard Skills)

Job Summary:

• Perform analytical assays to support upstream and downstream process development activities, to inform process understanding and to deliver process characterization activities.
• Learn and implement laboratory techniques and demonstrate excellent levels of accuracy and quality when carrying out analytical analyses.
• Carry out multiple laboratory-based assays each week and complete the data processing for these assays in a timely manner.
• Contribute to trouble shooting and technical investigations.
• Contribute to both departmental and company initiatives/projects.
• Ensure a high standard of record keeping and documentation of experiments and investigations
• Accountable for own performance in alignment with group objectives and deadlines.
• Familiar with the principles of experimental design and implementation.
• Presentation of scientific data at internal meetings.
• Contribute to the writing, revision and review SOPs and technical reports.
• Joint responsibility for maintenance and compliance of a GxP laboratory area and GxP “housekeeping” procedures.
• Work in Laboratory technical and cell culture, qPCR, molecular biology and/or HPLC

Skills on Resume:

• Analytical Assay Proficiency (Hard Skills)
• Laboratory Techniques (Hard Skills)
• Data Processing and Analysis (Hard Skills)
• Troubleshooting Skills (Hard Skills)
• Project Contribution (Soft Skills)
• Record Keeping and Documentation (Hard Skills)
• Accountability and Time Management (Soft Skills)
• Experimental Design Knowledge (Hard Skills)

Job Summary:

• Carry out sample analysis to the highest technical standards, on the Active Pharmaceutical Ingredients (APIs) for clients of Cambrex. 
• Facilitate closure of projects with minimal lead-time, whilst maintaining compliance to quality and safety systems, so that clients can progress development of their product/API.
• Familiar with working within ISO9001 and/or cGMP quality standards.
• Working independently and within a team in an R&D environment desirable but not a prerequisite.
• Working safely in a lab environment and adhering to local SHE policies.
• Able to participate in client meetings and discuss technical data clearly and succinctly.
• Practical experience in a range of bioprocess analytical techniques, such as but not limited to, cell-based assays, flow cytometry, nucleic acid extractions, qPCR, SDS PAGE, Western blot analysis, ELISA, and HPLC.
• An awareness of basic biopharmaceutical process development activities.
• Competency in data capture and reporting.
• Aseptic technique.
• Know general cellular and molecular biology laboratory and analytical techniques

Skills on Resume:

• Sample Analysis Skills (Hard Skills)
• Project Management Skills (Hard Skills)
• Quality Standards Knowledge (Hard Skills)
• R&D Environment Experience (Hard Skills)
• Lab Safety Adherence (Hard Skills)
• Client Interaction Skills (Soft Skills)
• Bioprocess Analytical Techniques (Hard Skills)
• Aseptic Technique (Hard Skills)

Job Summary:

• Extract and subsequent analysis of fragrances and flavors from marketed products, using various analytical techniques (such as steam distillation, Likens Nickersen, solvent extraction, headspace analysis using solid-phases microextraction (SPME).
• Operate GC and GC/MS instrumentation and assist in maintenance.
• Analyze GC-MS data and report results in excel format to Supervisor for review.
• Maintain and update flavor and fragrance raw material files, essential oil analysis files and Mass Spec libraries as needs arise and new or existing chemicals are introduced.
• Assist in Flavor Research Studies under the direction of a Senior Flavor Research Scientist.
• Assist in Flavor and Fragrance Problem Solving under the direction of a Senior Research Scientist.
• Assist in Analytical Method Development to support Flavor and Fragrance Divisions.
• Perform Internal R&D Lab Safety Audits with the Supervisor.
• An understanding of viral vector analytical principles and processes.
• Understanding of the Quality management reporting structure/responsibilities within OXB.
• Familiar with the regulatory requirements for analytical work (e.g. product specifications, stability testing guidelines etc).

Skills on Resume:

• Data Analysis and Reporting (Hard Skills)
• Database Management (Hard Skills)
• Flavor Research and Problem-Solving (Hard Skills)
• Analytical Method Development (Hard Skills)
• Lab Safety Audits (Hard Skills)
• Viral Vector Analytical Principles (Hard Skills)
• Quality Management (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary:

• Routine use of analytical instruments, including LC, SEC/GPC, MS, CD and in-vitro bioassays to characterise pharmaceutical & biopharmaceutical samples
• Set-up & perform new bioassays to characterize structure & function of protein-based biopharmaceuticals
• Report writing and interpretation of data for internal purposes and for external research partners
• Provide clear and frequent communication of results, sample status and equipment readiness
• Health and safety & risk-assessments
• Provide cross-function support when required
• Liaise with equipment and maintenance suppliers
• Support off-site analytical studies with third party vendors & CROs
• Report directly to the Lead Analytical Scientist and be part of a broad-ranging multidisciplinary team involved in the development of new drug products.
• Supervisory responsibility

Skills on Resume

• Analytical Instrumentation Proficiency (Hard Skills)
• Bioassay Development and Execution (Hard Skills)
• Data Analysis and Interpretation (Hard Skills)
• Communication Skills (Soft Skills)
• Health and Safety/Risk Assessment (Hard Skills)
• Cross-Functional Support (Soft Skills)
• Vendor and Supplier Liaison (Soft Skills)
• Collaboration with Vendors/CROs (Soft Skills)

Job Summary:

• Take a lead role in the development of fit-for-purpose analytical methods using platforms such as ddPCR, qPCR, Western Blot, ELISA, enzyme activity assays, NGS, flow cytometry, mass spectrometry and/or analytical ultracentrifugation.
• Validate select analytical methods for manufacturing, preclinical and clinical use according to appropriate guidelines (GMP, GLP, GCP, ICH, CLSI).
• Oversee transfer of assay methods to cross-functional colleagues and CMO/CRO partners.
• Coordinate method development, validation and testing timelines to meet deadlines for manufacturing and program milestones.
• Contribute to the development and evaluation of novel biomarkers in neuromuscular and neurological disease models.
• Contribute to experimental design to support process development colleagues.
• Perform analysis of manufacturing and preclinical study samples using qualified bioanalytical methods
• Working with AAV (Adeno-associated virus)
• Provide guidance, mentorship and development opportunities to junior scientists
• Keep an up-to-date notebook, prepare presentations and provide scientific analysis and recommendations in meetings with senior leadership
• Familiarize with cGMP/GLP requirements and FDA fillings
• Familiarize with HPLC/UPLC with various detectors, UV/vis, GC headspace chromatography, LC-MS, GC-MS, Particle size analyzer and other instruments

Skills on Resume:

• Analytical Method Development (Hard Skills)
• Validation Expertise (Hard Skills)
• Assay Transfer Management (Hard Skills)
• Project Coordination (Hard Skills)
• Biomarker Development (Hard Skills)
• Experimental Design (Hard Skills)
• Bioanalytical Analysis (Hard Skills)
• Leadership and Mentorship (Soft Skills)

Job Summary:

• Conduct necessary experiments for analytical method transfer/validation and investigations per guidelines provided by senior group members. 
• Contribute to analytical method development/optimization, validation and transfer in the laboratory
• Assist to review analytical testing procedure, method performance matrix and testing results across global testing network, provide some inputs to gap analysis reports, gap remediation recommendation and perform method optimization 
• Participate in cross functional teams in assay troubleshooting and OOS/OOT investigations
• Help draft analytical method transfer/validation related protocols and reports for late stage clinical and commercial programs.
• Participate in cross-functional project teams representing Analytical Sciences
• Help manage CRO/CRM analytical testing activities.
• Understanding of regulatory requirements e.g. GMP, GLP, GCP and/or Validation and Quality Management systems.
• Biotechnology industry experience in analytics, biological research and development or equivalent experience gained elsewhere.

Skills on Resume:

• Method Transfer/Validation (Hard Skills)
• Method Development/Optimization (Hard Skills)
• Testing Procedure Review (Hard Skills)
• Assay Troubleshooting (Hard Skills)
• Protocol and Report Drafting (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• CRO/CRM Management (Soft Skills)
• Regulatory Compliance (Hard Skills)

Job Summary:

• Subject matter expert for different analytical method with the focus on GC-MS
• Develop and perform GC-MS analysis for food products with different matrices
• Support installation and setup of new instruments
• Coordinate verification, calibration routines and maintenance program for laboratory equipment and instruments
• Conducts application/innovation projects work independently and/or in collaboration with both internal and external partners
• Works with internal and external customers on collaborative projects, developing customer partnerships, and provides analytical expertise as part of project support
• Setup analytical test programs for analyzing samples with different matrices
• Participates effectively on cross functional project teams
• Report and present results to stakeholders
• Be flexible in taking additional tasks
• Ensures the safety of all personnel and/or visitors in the lab

Skills on Resume:

• Analytical Expertise (Hard Skills)
• GC-MS Analysis (Hard Skills)
• Instrumentation Setup (Hard Skills)
• Equipment Maintenance (Hard Skills)
• Project Management (Hard Skills)
• Customer Collaboration (Soft Skills)
• Test Program Development (Hard Skills)
• Cross-functional Collaboration (Soft Skills)