WHAT DOES AN ANALYTICAL SCIENTIST DO?
The Analytical Scientist oversees procurement, experiment execution, and result documentation in the laboratory, ensuring efficiency and accuracy. They recommend equipment and process upgrades for improved quality and productivity, collaborating closely with supervisors to align project significance with superior customer service. Adaptable to new technologies and proficient in handling diverse materials, they maintain meticulous documentation, coordinate testing activities, and communicate effectively across cross-functional teams.
A Review of Professional Skills and Functions for Analytical Scientist
1. Analytical Scientist Duties
- Method Development: Assisting with the development of new analytical methods for new dosage forms.
- Formulation Support: Supporting formulation development work by analyzing samples in pre-formulation and formulation.
- Troubleshooting & Test Development: Troubleshooting existing methods and developing new test methods.
- Mentorship: Working with junior chemists to develop their skill sets.
- Training & Mentoring: Train and mentor junior scientists and laboratory technicians.
- Collaboration & Problem-Solving: Use product and testing expertise to collaborate with internal and external customers to determine root causes in product development and quality problems.
- Customer Support: Respond to customers’ feedback on technical problems and improve product value as well as customer satisfaction.
- Analytical Development: Utilize knowledge of analytical chemistry to develop and validate fit for purpose methods to support new product introduction activities.
- Scientific Communication: Author internal white papers and present scientific work at external technical conferences.
- Quality Assurance: Solve customers’ quality complaints and provide solutions to their technical issues.
- Technology Exchange: Participate in technology exchanges internally and externally with customers and production support teams both in person and virtually.
- Continuous Learning: Continuous training on the various analytical techniques and methods.
2. Analytical Scientist Details
- Analytical Techniques: Use of a broad range of analytical techniques including HPLC, UPLC, and SEC, Mass spectrometry, CD spectroscopy, and NMR coupled with in vitro bioassays such as antibody-binding and blockade or ELISA assays with colorimetric, fluorescence, or luminescence-based end-points.
- Instrument Operation: Routine use of analytical instruments, including LC, SEC, MS, CD, and in vitro bioassays to characterize pharmaceutical and biopharmaceutical samples.
- Bioassay Development: Set up and perform new bioassays to characterize the structure and function of protein-based biopharmaceuticals.
- Data Reporting: Report writing and interpretation of data for internal purposes and for external research partners.
- Communication: Provide clear and frequent communication of results, sample status, and equipment readiness.
- Method Development: Develop and optimize analytical methods for the characterization and quantification of natural product secondary metabolites, intracellular/extracellular metabolites, and proteins.
- Data Analysis: Analyze and interpret data from multiple 'omics platforms using bioinformatics tools and engage with other scientists and researchers to formulate hypotheses.
- Equipment Maintenance: Ensure that state-of-the-art analytical facilities and equipment (GC-MS/FID, LC- QQQ/Q-TOF, HPLC) are well-maintained and functioning efficiently.
- Research Support: Assist the R&D team in data acquisition, processing, and analysis.
- Coordination: Coordinating analytical requirements between various functional R&D teams.
3. Analytical Scientist Responsibilities
- Analytical Method Development: Develop and/or implement state-of-the-art analytical methods to determine potency, purity, and stability for drug substances and/or drug products.
- Experiment Execution: Execute high-quality in-house experiments and maintain accurate results in an electronic laboratory notebook.
- Data Presentation: Present internal and external data to cross-functional teams.
- Communication & Problem Solving: Effectively communicate any critical analytical issues and propose phase-appropriate solutions to the team.
- Instrumentation Maintenance & Expansion: Maintain and expand RAPT analytical instrumentation.
- Professional Representation: Professionally represent RAPT with contract manufacturing and testing labs.
- Investigation Management: Manage potential out of specification, out of trend investigations, and any method development or transfer issues.
- Regulatory Documentation: Contribute to the draft and review of documents for regulatory submissions.
- Data Monitoring & Evaluation: Monitor and evaluate release and stability data from CMOs and CROs for accuracy and GMP compliance.
4. Sr. Analytical Scientist Job Summary
- Analytical Methodology Development: Establish, develop, and/or optimize analytical methodology to test the potency of protein products utilizing binding or cell-based assays in the QC laboratories.
- Team Leadership & Development: Lead and develop a team of analysts in the implementation of potency assays.
- Industry Trends Awareness: Stay informed of current industry trends in potency assay development and implementation in the QC environment.
- Protocol Design & Review: Design, write, and review protocols for assay qualification/validation studies.
- Instrumentation & Technology Evaluation: Evaluate and make recommendations on new instrumentation and technology.
- Procedure Transfer: Transfer new or improved control test procedures to customer groups.
- Troubleshooting Leadership: Lead troubleshooting activities for established test methods used in development and release testing.
- Analytical Support for Process/Formulation: Provide analytical support in troubleshooting process and formulation problems.
- Independent Working: Perform job duties with limited direction from the supervisor.
- Scientific Study Design: Design scientifically sound studies and experiments, being given only a general outline of the study goal.
- Data Tabulation & Reporting: Tabulate results and write summary reports of assay development and validation studies.
- Findings Presentation: Present findings at departmental and interdepartmental meetings.
- Scientific Argument Development: Using the available scientific literature, develop scientific arguments for white paper justifications and investigation conclusions.
- Record Maintenance: Produce and maintain accurate records.
- SOP & Test Method Drafting: Write group SOPs and provides drafts of proposed test methods to QC.
- Training & Mentoring: Train junior-level group members and act as a mentor within the laboratory.
- Interdepartmental Representation: Represent Analytical Sciences in interdepartmental teams and meetings.
5. Analytical Scientist Accountabilities
- Analytical Method Development: Developing and validating fit-for-purpose analytical methods according to QbD principles (risk assessment, DoE, modeling) for APIs, Drug Products, and In Process Control (IPC).
- Process Support: Supporting API and Drug Product process development.
- Formulation Collaboration: Working together with the Product Development department to develop the best-suited formulations and establish clinically relevant specifications.
- Method Transfer: Transferring analytical methods to relevant commercial QC and manufacturing units and participating in their lifecycle management.
- Clinical Batch Testing: Ensuring release and stability testing of API and DP clinical batches from phase I to phase III.
- Raw Material Testing: Ensuring release testing of raw materials, starting materials, and intermediates of synthesis.
- Lab Activity Participation: Participating in the daily bench activities as well as supervising activities performed externally.
- Documentation Quality: Providing high-quality documentation of all technical work performed in the laboratory.
- Meeting Engagement: Actively participating in project meetings as well as internal scientific meetings.
- Methodology Implementation: Participating in the implementation of new state-of-the-art analytical methodologies and process improvements.
6. Analytical Development Scientist Functions
- Methodology Development: Develop flow cytometry and MOA-reflective methodologies for regulated and unregulated environments.
- Assay Development: Drive potency assay development for gene therapy, including flow cytometry, ELISA, and gene expression assays.
- Vector Assays: Develop vector characterization assays, focusing on sizing and aggregation.
- Assay Optimization: Optimize and execute assays for discovery research and pre-clinical development.
- Data Integration: Collaborate with R&D teams for data integration and presentation.
- Coordination: Liaise with internal groups for vector product evaluation.
- Documentation: Ensure thorough documentation for procedures and experiments.
- Training: Mentor and train junior associates.
7. Senior Analytical Scientist Job Description
- Analytical Development: Develop analytical methods for FX201 in collaboration with external partners such as central testing laboratories, contract research organizations (CRO), and contract manufacturing organizations (CMO).
- Experiment Support: Support experiment design, execution, data analysis for cell culture process.
- Method Review: Review analytical method development reports, qualification/validation protocols/reports, and instructions/SOP’s for relevant analytical functions.
- Data Analysis: Review and analyze analytical raw data.
- GMP Batch Release: Contribute to GMP batch release in collaboration with external partners and quality organization.
- Stability Management: Establish and manage biologics stability programs in collaboration with QC.
- Method Guidance: Guide external partners to design and execute method development and validation.
- QC Investigation Support: Provide support to QC investigations through experimental design, data mining, and technical writing.
- Cross-functional Teamwork: Work within cross-functional teams to support process development, product characterization, and manufacturing activities.
- Assay Support: Provide analytical support across groups and support assay transfer.
8. Analytical Scientist Overview
- Supply Management: Recommend purchase of supplies and chemicals for laboratory.
- Experimental Execution: Plan and conduct experiments while accurately reporting (written and verbal) results.
- Innovation: Recommend new equipment and processes to improve quality and/or productivity.
- Customer Service: Balance the needs of internal and external customers based on interaction with supervisor to gain an appropriate understanding of the project’s importance, while delivering superior customer service.
- Analytical Reporting: Provide timely analytical results on production samples waiting for lot release.
- Safety and Handling: Able to safely handle many different raw materials, internal and external products, applications, and instrumentation.
- Learning and Adaptation: Able to quickly learn new technologies with the assistance of peers and/or supervisors.
- Documentation: Maintain accurate documentation to support patent filings and other Huber processes.
- Testing Coordination: Coordinate testing work to meet product release and project needs.
- Consultation and Reporting: Routinely consult and report findings to supervisor in formats to allow for decision-making on future projects.
- Quality Improvement: Review and identify areas of improvement within the quality system.
- Cross-functional Communication: Communicate effectively with various cross-functional teams.
9. Analytical Scientist Details and Accountabilities
- Method Development: Assist the technical effort of the Analytical Center in the development, validation, and transfer of chromatographic methods. Work independently to design and perform quality scientific experiments to develop robust analytical methods.
- QbD Implementation: Implement Quality-by-Design (QbD) concepts in method development.
- Decision Making: Make sound scientific conclusions and decisions.
- Documentation: Draft and review analytical methods, protocols, and reports independently and execute study protocols.
- Data Analysis & Presentation: Compile and analyze data and present to the team during technical meetings.
- Client Communication: Participate in client meetings and/or teleconferences, communicating in English.
- Continuous Improvement: Support continuous improvement efforts in lab procedures, develop best practices, and ensure compliance with the Quality Management System.
- Technology Evaluation: Identify and evaluate new analytical technologies. Expand existing analytical capabilities.
- Audit Support: Support the document control system and coordinate internal audits, actions, and completion of actions.
10. Analytical Scientist Tasks
- Experimentation: Plan and conduct a variety of experiments and tests using agreed methods to support new product development, working to agreed schedules that support ambitious project timeframes.
- Data Documentation: Using agreed formats, record experimental data and prepare reports on work undertaken, including initial analysis, conclusions, and recommendations as a basis for further discussion and research.
- Problem Solving: Work to resolve technical/scientific problems in a timely manner by collaborating with other wound biology functional specialists and participate in related discussions that identify relevant theories and practical interventions.
- Knowledge Development: Develop and maintain understanding of the latest microbiology theories and research initiatives and make recommendations internally about any related changes to current methods and working practices.
- Knowledge Sharing: Develop and share expert functional knowledge, educating individuals across both R&D and the wider S+N business, and maintain a network of internal contacts who can offer advice when appropriate.
- Equipment Maintenance: Assist the Development Services Systems team with lab maintenance, equipment development, maintenance, and calibration as appropriate (in conjunction with the Facilities team).