Main Responsibilities and Required Skills for an Analytical Scientist

An Analytical Scientist is a professional who specializes in conducting scientific experiments and analyzing data to solve complex problems and make informed decisions. They play a crucial role in research and development, quality control, and process optimization in various industries such as pharmaceuticals, biotechnology, environmental sciences, and more. In this blog post, we will describe the primary responsibilities and the most in-demand hard and soft skills for Analytical Scientists.

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Main Responsibilities of an Analytical Scientist

The following list describes the typical responsibilities of an Analytical Scientist:

Aid in

Aid in the development of in vitro cell assays to test the efficacy of LNP formulations.

Analyze

Analyze and interpret data and prepare technical reports.
Analyze and interpret experimental data to draw meaningful conclusions.
Analyze raw materials, intermediates, and finished products for quality control.

Anticipate

Anticipate and recognise potential problems with equipment and initiate corrective actions.

Apply

Apply technical skills and functional knowledge to projects / assignments.

Assist in

Assist in method development and method transfer in support of various projects.
Assist in regulatory submissions and inspections.
Assist in the development and review of standard operating procedures (SOPs).
Assist in the development of approaches to solving moderate problems.
Assist in the development of novel approaches to solve moderately difficult problems.
Assist in the develpment of approaches to solving moderate problems.
Assist the Method Development team in the identification of discriminatory dissolution methods.

Author

Author and Review technical reports, methods, and regulatory documents.
Author, Review, and Approve technical reports, methods, and regulatory documents.

Calculate

Calculate results using Excel spreadsheets and / or instrumental software.

Calibrate

Calibrate laboratory instruments to specified technical.

Collaborate with

Collaborate with cross-functional teams to support research and development projects.
Collaborate with external partners and vendors for testing and analysis.
Collaborate with external research organizations for collaborative projects.
Collaborate with manufacturing teams to troubleshoot production issues.

Collect

Collect activity and summary reports for assigned tasks to facilitate SRED Taxes Credit reporting.

Communicate

Communicate with various internal departments as well as third parties.

Complete

Complete Quality Risk Assessments.

Conduct

Conduct data integrity checks and maintain accurate records.
Conduct literature reviews and stay updated on relevant scientific advancements.
Conduct risk assessments to ensure safe handling of hazardous materials.
Conduct stability studies to assess the shelf life of products.

Contribute to

Contribute to the continuous improvement of analytical processes and techniques.

Create

Create innovative methodologies.
Create internal standard operating procedures (SOPs) for relevant techniques.

Design

Design and execute experiments to solve specific research questions or problems.

Develop

Develop and evaluate analytical test methods for raw materials and in-process and finished products.
Develop and optimize chromatographic separation techniques.
Develop and validate analytical methods for the analysis of samples.
Develop and validate new methods and methodologies.
Develop custom analytical services upon request.
Develop new methods for characterization and comparability testing.

Document

Document results in electronic laboratory notebooks.Review and witness notebooks of peers.
Document the activities related to sample analysis and assist in verifying various documents.
Document the execution, procedure, results, and conclusions of experiments in a detailed manner.

Ensure

Ensure all analytical activities meet good laboratory practices and company's policies.
Ensure analytical methods are fit for purpose through method qualification and validation activities.
Ensure client and company confidentiality is maintained.
Ensure compliance with Corporate Quality Systems.
Ensure compliance with regulatory guidelines and quality standards.
Ensure data integrity is maintained for all work performed.
Ensure safety is at the forefront when handling chemicals, equipment, and performing analyses.
Ensure that any analytical non-conformance or OOS are highlighted to management and investigated.

Evaluate

Evaluate and recommend new analytical instruments and technologies.

File

File and maintain laboratory records following Good Manufacturing Practices and as directed.

Follow

Follow established HSE policies and procedures.
Follow relevant Frontida SOP's and FDA / ICH guidance.
Follow safety procedures and good laboratory practice.
Follow the guidance and maintain records in ELN, LIMS, Freezer inventory and shipping systems.

Follows-up

Follows-up on result analysis and assists in finding solutions to bioanalytical issues.

Foster

Foster Collaboration and Teamwork.

Help

Help develop novel analytical methods or method alterations as necessary.

Identify

Identify technical alternatives from literature review.
Identify the appropriate conditions required for a biorelevant dissolution method.

Implement

Implement and maintain laboratory safety protocols and practices.

Initiate

Initiate analysis runs using the appropriate instruments and software.

Interact

Interact in multi-functional teams for AR&D improvements, audits, regulatory inspection.
Interact positively with external clients to answer questions and provide necessary information.

Interface with

Interface with internal and external partners such as Formulations and Quality.
Interface with peers in other departments, senior management, customers and regulatory agencies.

Interpret

Interpret analytical results generated by the Analytical Services team.
Interpret and analyze data.
Interpret and tabulates results of analysis.

Investigate

Investigate and implement process improvements to enhance efficiency.
Investigate and resolve deviations or out-of-specification results.

Keep

Keep abreast with new process chemistry and analytical techniques.
Keep up to date with scientific and technical developments.

Lead

Lead Analytical Scientist, Research & Development.
Lead material characterization and analysis efforts within the R& D team.
Lead method development and validation activities with supervision.
Lead the biophysical characterization of proteins.
Lead with Integrity and Respect.

Learn

Learn continuously and stay abreast with science trends.

Log

Log results into LIMS database.

Maintain

Maintain a high level of productivity in the lab.
Maintain appropriate lab records and documentation.
Maintain a safe and effective laboratory environment in accordance with EHS policies.
Maintain good laboratory safety and housekeeping standards.
Maintain GXP compliant good documentation with high level of detail.
Maintain laboratory and freezer inventory, manage instrumentation maintenance.
Maintain various characterization instruments and troubleshoot any issues promptly.

Manage

Manage data in appropriate systems to ensure compliance and data integrity.
Manage the development and validation of analytical methods for pharmaceutical products.

Mentor

Mentor and provides technical advice to individuals within the team.

Negotiate

Negotiate contracts and work orders for external bioanalytical and drug metabolism.

Operate

Operate and maintain laboratory equipment and instruments.

Organise

Organise the required activities as a function of established priorities.

Oversight

Oversight and development of junior staff members.

Participate

Participate in equipment and IT systems validation activities.
Participate in the determination of in-vitro / in-vivo . (.
Participate in the development and optimization of manufacturing processes.

Perform

Perform all activities related to processing and analyzing biological samples.
Perform any other tasks / duties as assigned by management.
Perform basic statistical analysis to support analytical testing.
Perform Compendial and non-compendial testing on Raw Materials and Drug Substances.
Perform extractions using standard industry methods.
Perform IQ / OQ / PQ and maintain lab equipment.
Perform laboratory experiments and tests using advanced instrumentation.
Perform laboratory work to support product or process troubleshooting and special investigations.
Perform method development and method transfer in support of various projects.
Perform method validation and verification studies.
Perform microsomal preparation and evaluation of metabolism of small molecules.
Perform other functions as required to support the R& D operation.
Perform stability testing in accordance regulatory guidelines.
Perform statistical analysis of data to identify trends and patterns.
Perform support tasks to meet the needs of laboratory users.

Plan

Plan and conduct analytical tests for drug development and transfer the methods to CDMO.

Prepare

Prepare analytical standards and reagents.
Prepare and implement stability protocols and scheduling.
Prepare and present scientific reports and presentations.
Prepare and review bioanalytical reports and packages for regulatory.
Prepare and review technical documents, including.
Prepare chemical solutions according to standard.
Prepare detailed and accurate analytical reports to share internally or with PNI's clients.
Prepare presentation materials, literature search, etc..
Prepare reagents, standards, Medias, etc. needed for analysis.

Present

Present results of experiments and innovation efforts to teams and internal governance bodies.

Provide

Provide analytical expertise to troubleshoot and resolve issues in a timely manner.
Provide coaching and guidance to junior team members on technical issues.
Provide data for regulatory submissions.
Provide detailed chemical analysis on biological molecules, especially nucleic acids.
Provide recommendations to the formulation scientists as warranted by the analytical data.
Provide support in maintenance and usage of all analytical instrumentation.
Provide technical expertise and guidance to project teams.
Provide technical input during inspections and audits.
Provide technical input for the analytical development.
Provide testing support to internal customers using these chromatography techniques (GC and HPLC).
Provide training to QC analysts after methods are.

Read

Read, understand and explain technical data.

Record

Record test results utilizing prescribed data reporting.
Record the results in approved notebooks, reports and logbooks.

Report

Report findings and maintain report system (e.g. LIMS).

Represent

Represent the laboratory in audits.

Resolve

Resolve advanced and complex issues related to development of cannabis products and projects.
Resolve technical issues and make recommendations on new technologies and instrumentation.

Review

Review and assimilate new information effectively with the rest of the Analytical team.
Review new developments and provide expert advice.

Routine

Routine troubleshooting of issues in testing and products with internal and external customers.

Set-up

Set-up, adjust, maintain and operate laboratory.

Share responsibility for the routine calibration of analytical equipment such as, but.

Sound

Sound suggestions or recommendations.

Stop

Stop any observed unsafe acts and obey facility safety rules and procedures.

Streamline

Streamline and automate current processes that are not platform based.

Support

Support safety policies and programs.
Support technology transfer from research to production.

Track

Track record of delivery of decision-making experimental data.

Train

Train and mentor junior laboratory staff on analytical techniques and methods.

Troubleshoot

Troubleshoot in analysis and equipment when quality.
Troubleshoot instrument issues and perform routine maintenance.

Understand

Understand and adhere to Good Manufacturing Practices and Good Lab Practices.
Understand and conduct studies for method.

Utilize

Utilize proactive thinking to generate creative solutions to complex technical problems.

Work with

Work closely with CRO as SME for analytical methods development.
Work closely with other departments (including QA, QC & Formulation).
Work cross-functionally and receives exposure to several departments.

Write

Write and review bioanalytical reports to support DMPK studies.
Write protocols and reports.
Write, review, and edit internal technical reports, quality documents and external presentations.
Write SOP's, analytical methods, stability protocols, method validation protocols and analytical.
Write technical reports describing bioanalytical work suitable for inclusion in regulatory packages.
Write the method validation reports.

Most In-demand Hard Skills:

The following list describes the most required technical skills of an Analytical Scientist:

Proficiency in various analytical techniques such as HPLC, GC, MS, NMR, etc.
Strong knowledge of spectroscopy, chromatography, and mass spectrometry.
Experience with method development, validation, and transfer.
Understanding of statistical analysis and experimental design.
Proficiency in using laboratory equipment and instrumentation.
Knowledge of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
Familiarity with regulatory guidelines and requirements (e.g., FDA, ICH).
Expertise in data analysis software and statistical tools.
Understanding of quality control and quality assurance principles.
Knowledge of laboratory safety protocols and procedures.
Proficiency in software for data acquisition, processing, and visualization.
Experience with sample preparation techniques and extraction methods.
Familiarity with computerized laboratory information management systems (LIMS).
Understanding of validation and verification protocols.
Knowledge of analytical chemistry principles and techniques.
Proficiency in using electronic lab notebooks (ELNs) for documentation.
Experience with dissolution testing and stability studies.
Knowledge of pharmacopoeial monographs and compendia.
Expertise in handling and analyzing complex biological or chemical samples.
Understanding of Good Documentation Practices.

Most In-demand Soft Skills

The following list describes the most required soft skills of an Analytical Scientist:

Strong analytical thinking and problem-solving skills.
Excellent attention to detail and accuracy in data interpretation.
Effective communication skills to convey complex scientific concepts.
Collaborative mindset for working in cross-functional teams.
Time management and organization skills to handle multiple projects.
Adaptability and flexibility in a dynamic laboratory environment.
Critical thinking abilities to evaluate experimental outcomes.
Curiosity and a continuous learning mindset to stay updated on scientific advancements.
Teamwork and leadership skills to coordinate and mentor junior scientists.
Integrity and ethical conduct in scientific research and data handling.

Conclusion

An Analytical Scientist plays a crucial role in scientific research, development, and quality control by utilizing advanced analytical techniques and scientific principles. They are responsible for designing experiments, analyzing data, ensuring regulatory compliance, and contributing to process improvement initiatives. Possessing a combination of technical skills in analytical techniques, scientific knowledge, and laboratory practices, along with essential soft skills such as critical thinking, communication, and teamwork, Analytical Scientists are well-equipped to contribute to advancements in various industries and support scientific innovation.