Main Responsibilities and Required Skills for Analytical Chemist
An Analytical Chemist is a professional who performs analysis and reports results using a variety of analytical and wet chemistry instrumentation. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Analytical Chemists.
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Main Responsibilities of Analytical Chemist
The following list describes the typical responsibilities of an Analytical Chemist:
Act
Act independently to drive experimentation & testing.
Adopt
Adopt and maintain a culture of excellence and quality in all aspects of his / her job function.
Align
Align them appropriately with small molecule program practices.
Assign
Assign workflow in the laboratory in conjunction with Analytical Chemist Senior Level.
Assist in
Assist / facilitate resolution of assay method and sample analysis issues.
Assist in performing routine auditing of laboratory areas.
Assist in reviewing Standard Operating Procedures.
Assist in the development, troubleshooting, and testing of proof-of-concept / prototype equipment.
Assist in the establishment of procedures.
Assist in the investigation and resolve aberrant or unusual results.
Assist in writing technical reports and procedures.
Assist Sales and Marketing with technical support opportunities.
Assist SOP training for new personnel and on SOP revisions.
Assist with Annual Drug Product Review (APR) process.
Assist with drug formulation and development.
Assist with Process development, Product Validation, and Quality Control.
Assist with troubleshooting and repairing equipment malfunctions.
Assure
Assure right-first-time execution of departmental methods and SOPs.
Audit
Audit SOPs and update, as required.
Author
Author protocols and reports.
Average
Average level of written and verbal communication skills required for successful job performance.
Carry out
Carry out duties in compliance with established business policies.
Carry out all duties in line quality procedures, cGMP regulatory guidelines and safety standards.
Clean
Clean laboratory at specified intervals.
Communicate
Communicate with team members to ensure project goals and timelines are met.
Compile
Compile reports and participate in customer reviews in West Lafayette and in the field.
Conduct
Conduct all work in a good team environment focusing on meeting project timelines.
Conduct analysis of samples using the appropriate analytical instruments.
Conduct basic instrumentation testing on laboratory analysis equipment.
Conduct experiments of basic complexity and interpret the results.
Conduct experiments using HPLC / UPLC / GC in support of method development and validation.
Conduct other tests required for dosage submissions.
Conduct polymorph and salt screening and characterization of solid forms.
Conduct routine analysis for nitrosamine impurities.
Conduct testing using a variety of analytical and wet chemistry instrumentation.
Conduct work in the spirit of cGMP, with a focus on safety and regulatory requirements.
Contribute to
Contribute to authoring of protocols and reports.
Contribute to preparation of standard operating procedures for analytical assays and instrumentation.
Contribute to project team and brainstorming meetings.
Coordinate
Coordinate all CMC aspects of the analytical development program with other functional areas.
Coordinate method transfers between clients, R&D group and other departments.
Coordinate release of liquid batches including designation of reassay / expiration date.
Create
Create reports of data and analysis and suggest action to be taken.
Designate
Designate appropriate and trained personnel to perform required tasks.
Determine
Determine the toxicity and pH of waste tanks at designated intervals.
Develop
Develop analytical methods to support product and process development team.
Develop and execute complex procedures or methods with high quality.
Develop and execute efficiency improvement projects.
Develop and validate analytical methods.
Develop and validate novel test methods for trace level analysis.
Develop industry relationships and network within the professional organizations.
Develop method comparability and bridging studies to implement new analytical methods.
Develop methods for new analytical applications for West Lafayette current products & projects.
Document
Document all testing, deviations, and investigations etc. as per cGMP and MTI guidelines.
Draft
Draft test methods and specifications.
Draft technical reports and applicable documents to support regulatory submissions.
Drive
Drive toward solutions to project goals.
Ensure
Ensure adequacy of record keeping.
Ensure compliance in all functional activities and support quality / compliance activities.
Ensure compliance with government rules and regulations (FDA, cGLP, OSHA, etc.).
Ensure compliance with government rules and regulations (FDA, cGxP, OSHA, etc.).
Ensure consumer is at the heart of product development.
Ensure patient first culture within the team.
Ensure proper new / refresher training of Analytical I Chemists.
Ensure release of raw materials, batches, and finished products are done efficiently.
Ensure that all analytical testing requirements are completed following safety.
Ensure that laboratory database (LIMs) meets customer needs.
Establish
Establish and reviews complex plans for multiple projects or activities.
Evaluate
Evaluate analytical methods and procedures and recommend improvements.
Execute
Execute basic operations required to keep the department running.
Execute procedures or methods of moderate complexity with high quality.
Facilitate
Facilitate and leads investigations for out of specification and out of trend results.
Foster
Foster Collaboration and Teamwork.
Furnish
Furnish report to QC Lab Manager on a continuous basis.
Generate
Generate accurate results while following the SOPs and / or protocol relevant to the test.
Generate developmental and GMP data.
Generate high quality data to support product purity, characterization and stability.
Generate quality system-compliant data.
Identify
Identify and recommend business opportunities on a project specific basis.
Identify the level of knowledge.
Implement
Implement project plans comprehending resource, budget, facility and regulatory requirements.
Innovates
Innovates through patent filings and / or scientific publications.
Interpret
Interpret, monitor and trend stability data for starting materials, drug substance and drug product.
Investigate
Investigate and solve analytical technical issues as they arise throughout the organization.
Investigate out of specification an out of trend data, and recommend CAPA.
Investigate out of specification results.
Investigate out of specification results to determine final disposition.
Investigate and troubleshoot analytical issues.
Keep
Keep up-to-date on advances in measurement systems through open sources.
Lead
Lead efforts to develop new assays and improve existing methods.
Lead or assist in bringing new analytical technologies in house.
Lead with Integrity and Respect.
Liaise with
Liaise with clients regularly to maintain superior relationships.
Maintain
Maintain Analytical files and records in accordance with GMP and company.
Maintain a safe work area that facilitates the conduct of research and development.
Maintain essential inventory and ensure common areas of the lab are well kept and orderly.
Maintain high quality documentation in accordance with applicable regulatory guidance and Site SOPs.
Maintain Lab cleanliness in a timely manner.
Maintain product and testing inventory and comply with the inventory tracking system.
Maintain QA / QC system which include writing SOPs.
Maintain records and notebooks in a professional, accurate manner.
Maintain records and prepare reports and correspondence related to the work.
Make
Make recommendations for implementation of new measurement systems supported by experimental data.
Manage
Manage DocuSign for study plans, amendments and other appropriate documents requiring DocuSign.
Manage multiple fast-paced projects.
Manage multiple projects and the analytical chemists that are executing R&D on these projects.
Mentor
Mentor and develop associates in the organization.
Mentor junior team members.
Modify
Modify and streamline processes, find more efficient ways of doing your job.
Monitor
Monitor analytical method performance as well as continuous improvements to achieve project goals.
Monitor daily to deal with external issues that that interfere with schedules.
Operate
Operate analytical instruments such as HPLC, LCMS, SFC, NMR, DSC / TGA, and XPRD.
Operate general analytical instruments during stability testing.
Optimize
Optimize and develop new sample preparation methods.
Optimize the HPLC-UV for injections.
Oversee
Oversee the inventory of supplies in the chemistry laboratory.
Own
Own your decisions, actions and outcomes, and promptly correct mistakes.
Participate
Participate in Operational Excellence initiatives and programs.
Participate on cross-functional teams.
Perform
Perform analysis and report results in accordance with GMP / GLP requirements.
Perform analytical method validations and prepare data for review and reports.
Perform analytical testing on external sample submissions.
Perform and analyze experiments in an autonomous manner.
Perform calibration, reading, and recording of instruments within the Analytical Chemistry Lab.
Perform cleaning method development and qualification.
Perform data analysis and engage in technical discussions about analytical results + methods.
Perform equipment maintenance and calibrations as required.
Perform experiments with expertise and with finesse in technique.
Perform GMP investigations and inspection.
Perform HPLC analysis of lipids and mRNA.
Perform investigations into laboratory Out of Specification Results (OOS).
Perform method development activities.
Perform method transfer, method validation and / or special project assignments as assigned.
Perform method validation or transfer activities.
Perform other assignments as directed by Quality Control Laboratory Team Lead / Supervisor.
Perform other duties as directed by QC Specialist or QC manager.
Perform other duties & projects as assigned.
Perform QC and in process testing of Drug substance and Drug Product.
Perform review functions in LIMS or other computerized systems.
Perform review of test data, which includes overall documentation practices.
Perform solid state characterization techniques.
Perform stability and forced degradation studies of the target small molecules.
Perform structural characterization of isolated small molecules.
Perform Testing / Analysis.
Perform these analyses mainly by HPLC and spectrometry.
Perform various types of testing under cGMP, as appropriate.
Perform wet chemistry tests such as pH, specific gravity, and Viscosity.
Plan
Plan resource allocation and distribution.
Prepare
Prepare and maintain laboratory test solutions.
Prepare and maintains stock solutions.
Prepare bioanalytical sections of clinical and regulatory documents.
Prepare environmental samples using multiple methods of sample preparation / extraction techniques.
Prepare non-study related shipment requests.
Prepare of the analytical sections of regulatory documents, protocols and reports.
Prepare, optimize and troubleshoot the instrumentation (HPLC / LCMS) for injections.
Prepare reagents, standards, media and mobile phase as needed for analyses.
Prepare reagents to be used in analysis as per written SOPs or manager's instructions.
Prepare SOP's, batch records and other documents for quality review.
Prepare standards / controls, media and sample solutions; and maintains appropriate records.
Prepare technical worksheets and procedures, and develop validation plans and reports, as required.
Present
Present scientific observations to others.
Process
Process qualification studies for GMP-level manufacturing.
Prompt
Prompt Scientists of upcoming draft and final report shipment dates.
Provide
Provide analytical support to both process development and stability.
Provide assistance in troubleshooting and maintenance of laboratory equipment.
Provide backup analytical support to existing personnel in support of lab activities.
Provide guidance, coaching, and training to the analytical technicians as required.
Provide laboratory support to R&D.
Provide leadership and supervision to professional personnel and technicians.
Provide reports and answer departmental questions during regulatory inspections.
Provide sample management and logistics for a large volume of samples.
Provide technical assistance to operations for specialized activities.
Provide training and / or other assistance to other analysts as required.
Provide training and / or supervision to junior staff, as needed.
Purpose
Purpose of internal / external contacts is not regularly related to complex matters.
Receive
Receive, store, verify, process and dispose of dose formulations and biological samples for analysis.
Recognize
Recognize and elevate changes in project scope or execution for review by project director.
Record
Record data, analyze results, and maintain accurate and up-to-date records.
Repair
Repair and uptime of advanced laboratory electronics and instrumentation.
Report
Report scientific results according to Standard Operating Procedure guidelines.
Report writing and data review.
Respond
Respond to collaborators inquiries and troubleshooting requests.
Review
Review analytical data generated by the services and ensure adequacy of record- keeping.
Review notebooks and raw data for GMP / GLP / GDP compliance.
Review technical data, documents, and proposals as required.
Review testing with R& D, schedule workload, review OOS.
Schedule
Schedule and review quarterly monitoring of micro of facility.
Substitute
Substitute and / or assist department colleagues.
Supervise
Supervise on a project level.
Supervise technical staff, including work assignments and performance management.
Support
Support analytical scientists to complete milestones for development programs.
Support chemical development and formulation development.
Support department in chromatography techniques.
Support material evaluation process for new materials.
Support method and / or product transfer and NPI activity as necessary.
Support operation and qualification of analytical laboratories and equipment.
Support protocol and report development for analytical procedures and instrumentation.
Support the team and support activities related to analytical methods and instrumentation.
Test
Test and provide a complete characterization of toxicology supplies.
Test clinical and submission batches for stability and release.
Train
Train and mentor junior chemists and technicians as needed.
Train, coach or mentor others on technical, personal development or business issues.
Train lab technicians in the use of instruments, methodology, as necessary.
Train new analysts on analytical testing.
Train personnel on analytical testing as needed.
Train lower-level scientists.
Translate
Translate top-level goals to specific project level goals for individual team member.
Troubleshoot
Troubleshoot and maintain HPLC (high performance liquid chromatography).
Troubleshoot and resolve instrument problems.
Troubleshoot instrumentation and method issues.
Troubleshoot methods and provide technical guidance across discovery and development programs.
Troubleshoot technical issues / difficulties with methods.
Use
Use and maintains laboratory instruments such as HPLC, GC, ICP, FTIR, Titrations, etc..
Use of HPLC and UPLC to characterize Pharmaceutical drug products and intermediates.
Use sophisticated laboratory instrumentation and computer systems to collect and record data.
Use statistical data analysis methods to evaluate analytical test data.
Validate
Validate and transfer QC release and stability methods to third party CMOs.
Work with
Work in accordance with established GMP and safety requirements.
Work largely independently on well-defined projects and assignments.
Work with minimum supervision, conferring with superior on unusual matters.
Most In-demand Hard Skills
The following list describes the most required technical skills of an Analytical Chemist:
Method Development
GC
MS
Validation
Mass Spectrometry
Biochemistry
GC-MS
GMP
GLP
Instrumentation
Lims
Wide-Variety Of Software And Information Systems
Biology
Business Acumen
Hplc-Ms
Physical
Computer
DSC
NMR
TGA
Chemical
Excel
Liquid Chromatography
Pharmaceutical Industry
Most In-demand Soft Skills
The following list describes the most required soft skills of an Analytical Chemist:
Written and oral communication skills
Organizational capacity
Attention to detail
Interpersonal skills
Problem-solving attitude
Analytical ability
Creative
Multi-task
Team player
Adaptable to changes
Flexible
Work independently with little direction
Critical thinker
Documentation
Positive attitude
Accurate
Detail-oriented
Leadership
Meet project milestones under general supervision
Meticulous
Organized
Resourceful
Self-motivated
Self-starter
Thrive in team environment
