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Key Responsibilities and Required Skills for Associate Chemist

💰 $48,000 - $68,000

ChemistryAnalytical ChemistryQuality ControlLaboratoryResearch & Development

🎯 Role Definition

The Associate Chemist is a hands-on laboratory professional who performs routine and investigative chemical analyses to support R&D, quality control (QC), and manufacturing release activities. This role combines practical laboratory execution (sample prep, chromatography, spectroscopy, titration, and wet chemistry) with rigorous documentation, adherence to SOPs, data review, and collaboration across cross-functional teams (R&D, QA, Manufacturing). The Associate Chemist contributes to method development, method validation, stability testing, and continuous improvement initiatives while maintaining laboratory safety and compliance with GMP/GLP and regulatory expectations.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Laboratory Technician / Lab Assistant
  • Chemistry Intern / Co-op student
  • Quality Control Technician

Advancement To:

  • Senior/Analytical Chemist
  • QC Supervisor or Lead
  • R&D Scientist / Formulation Scientist
  • Validation Scientist or Method Development Lead

Lateral Moves:

  • Quality Assurance Specialist
  • Process Development Technician
  • Regulatory Affairs Associate

Core Responsibilities

Primary Functions

  • Execute routine and non-routine analytical testing using chromatographic and spectroscopic techniques (HPLC, UHPLC, GC, GC-MS, LC-MS, UV-Vis, FTIR, AAS), ensuring accurate, timely results for released batches, raw materials, in-process samples, and stability studies.
  • Prepare samples, standards, calibration curves, and reagents following established SOPs and validated methods; perform appropriate dilutions and sample extractions to meet method requirements and detection limits.
  • Perform method validation and verification activities, including precision, accuracy, linearity, specificity, robustness, limit of detection (LOD) and limit of quantitation (LOQ) assessments, and document results in validation reports.
  • Troubleshoot and perform first-line maintenance on analytical instruments (e.g., HPLC column changes, injector troubleshooting, GC septa replacement, mass spectrometer tuning) and coordinate repairs with service vendors when required.
  • Record experimental procedures, observations, raw data, and calculations accurately in bound notebooks or electronic lab notebooks (ELN) according to data integrity principles and company documentation practices.
  • Review and interpret analytical data, perform basic statistical analysis (e.g., mean, RSD, trend analysis) to support release decisions, stability reporting, and trend investigations.
  • Execute and support stability study protocols, including sample preparation, analysis at assigned stability intervals, trend tracking, and preparation of stability data packages for review.
  • Maintain and reconcile inventories of reagents, standards, columns, and consumables; prepare replenishment requests and verify certificate of analysis (CoA) for incoming materials.
  • Adhere to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and internal quality systems; follow documented procedures and participate in internal and external audits as a subject matter contributor.
  • Generate clear, professional analytical reports, certificates of analysis (CoA), batch records, and deviations with timely follow-up and CAPA implementation when required.
  • Perform forced-degradation and stress testing experiments to assess product stability and degradation pathways as part of formulation or method development projects.
  • Assist in method transfer and technology transfer activities by preparing method transfer protocols, executing comparative testing, and documenting results to facilitate process scale-up or handoff to QC labs.
  • Participate in calibration and preventive maintenance programs by maintaining calibration logs, performing routine calibrations, and ensuring instruments are within specification and documented.
  • Support root cause investigations for out-of-specification (OOS) and out-of-trend (OOT) results by executing retests, orthogonal analyses, and documenting investigation findings in collaboration with QA.
  • Use laboratory information management systems (LIMS) and electronic data capture tools to log samples, retrieve test methods, import/export analytical results, and ensure proper data archiving and traceability.
  • Conduct wet chemistry analyses and classical titration techniques (acid/base titrations, complexometric titrations) for assay and impurity testing where applicable.
  • Prepare, review, and help revise standard operating procedures (SOPs), work instructions, and method documentation to reflect current practices and regulatory expectations.
  • Support formulation screening, small-scale synthesis, and bench-top experiments for R&D projects by preparing reaction mixtures, monitoring reactions, and performing intermediate and product analyses.
  • Ensure laboratory safety and environmental compliance by following hazardous waste disposal procedures, maintaining up-to-date safety data sheets (SDS), and participating in safety training and emergency response drills.
  • Participate in cross-functional project teams to support product development, tech transfers, and troubleshooting of process-related analytical challenges, offering experimental data and technical recommendations.
  • Train and mentor junior staff, temporary technicians, or interns on lab techniques, instrument operation, documentation expectations, and safety practices to maintain consistent data quality.
  • Maintain awareness of current analytical techniques, regulatory guidance (FDA, EMA), and industry best practices; propose and implement continuous improvement ideas to increase throughput, reduce variability, and optimize costs.
  • Perform sample custody activities including sample receipt, labeling, storage, and chain-of-custody documentation for internal and external laboratory partnerships.
  • Support contamination control and environmental monitoring programs when required, collecting and analyzing samples and documenting trends.

Secondary Functions

  • Assist with method development projects by conducting literature reviews, preparing experimental plans, and executing preliminary experiments under supervision.
  • Participate in continuous improvement initiatives such as Lean/Six Sigma projects to improve lab throughput, reduce waste, and enhance data quality.
  • Support regulatory submissions by assembling analytical data packages, providing method descriptions, and clarifying analytical procedures for cross-functional reviewers.
  • Help maintain laboratory housekeeping, inventory organization, and calibration schedules to ensure compliance and audit readiness.
  • Liaise with procurement and vendors to obtain quotes, evaluate service agreements for instrument maintenance, and ensure timely supply of critical reagents and consumables.
  • Attend departmental meetings, present analytical findings, and collaborate with R&D, manufacturing, and QA to prioritize testing and project timelines.
  • Support external laboratory coordination for outsourced testing, including sample shipments, chain-of-custody documentation, and result reconciliation.
  • Contribute to training material creation and competency assessments for new assays and instrumentation.

Required Skills & Competencies

Hard Skills (Technical)

  • Proficient operation and troubleshooting of HPLC/UHPLC systems, including method setup, gradient optimization, column selection, and routine maintenance.
  • Hands-on experience with GC and GC–MS for volatile analysis, including sample injection techniques, column care, and detector tuning.
  • Familiarity with LC–MS or LC–MS/MS workflows for sensitive impurity and trace-level analyses, including basic mass spectrometer operation and sample preparation.
  • Practical knowledge of UV-Vis, FTIR, and other spectroscopy techniques for identity and assay testing.
  • Strong sample preparation skills: solid-liquid extraction, liquid-liquid extraction, filtration, dilution strategies, and use of syringes and autosamplers.
  • Experience performing method validation and verification per ICH guidelines (precision, accuracy, specificity, linearity, LOD/LOQ, robustness).
  • Working knowledge of GMP, GLP, SOP compliance, and documentation standards for regulated environments.
  • Competence in using LIMS, ELN, chromatography data systems (e.g., Empower, Chromeleon, OpenLab), and analytical instrument software.
  • Solid ability to analyze data using Excel (pivot tables, formulas), basic statistical tools (RSD, t-tests), and graphing to support data interpretation.
  • Familiarity with stability protocols, forced degradation studies, and preparation of stability data packages.
  • Experience with titration, wet chemistry, and classical analytical techniques for routine assays.
  • Understanding of laboratory calibration, preventive maintenance, and qualification processes (IQ/OQ/PQ) for equipment.
  • Knowledge of lab safety regulations (OSHA), hazardous waste handling, and proper use of PPE.
  • Ability to prepare technical reports, SOPs, and regulatory documentation with clear scientific writing and accurate record-keeping.

Soft Skills

  • Excellent attention to detail and commitment to data integrity and reproducibility.
  • Strong written and verbal communication skills for clear reporting, SOP writing, and cross-functional collaboration.
  • Problem-solving mindset with the ability to investigate unexpected results and propose corrective actions.
  • Time management and prioritization skills to manage multiple testing requests and project deadlines.
  • Team player who collaborates with R&D, manufacturing, QA, and external labs to achieve project goals.
  • Adaptable and curious, continuously learning new instrumentation and analytical methods.
  • High ethical standards and professionalism in handling confidential and regulated data.
  • Ability to train and mentor junior colleagues with patience and clarity.
  • Critical thinking and experimental design capabilities for troubleshooting and method optimization.
  • Resilience under pressure during tight timelines, audits, or production release windows.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor of Science (B.S.) in Chemistry, Analytical Chemistry, Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a closely related field.

Preferred Education:

  • Master’s degree (M.S.) in Analytical Chemistry, Pharmaceutical Chemistry, or relevant discipline, or B.S. with 1–3 years of relevant laboratory experience.

Relevant Fields of Study:

  • Analytical Chemistry
  • Organic Chemistry
  • Pharmaceutical Chemistry
  • Biochemistry
  • Chemical Engineering
  • Materials Science

Experience Requirements

Typical Experience Range:

  • 0–3 years hands-on laboratory experience (entry-level associate roles), up to 3–5 years for more autonomous associate positions.

Preferred:

  • 1–4 years of experience in analytical testing environments (pharmaceutical, biotech, fine chemicals, or consumer products) with demonstrated experience on HPLC/GC and familiarity with GMP/GLP documentation.
  • Prior experience with method validation, stability testing, LIMS, and chromatography data systems is highly desirable.
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