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Key Responsibilities and Required Skills for Chemist

💰 $55,000 - $95,000

ChemistryLaboratoryR&DQuality ControlAnalytical Chemistry

🎯 Role Definition

Experienced, detail-oriented Chemist responsible for designing and executing laboratory experiments, performing analytical testing, developing and validating methods, and ensuring compliance with regulatory and safety standards. The role requires hands-on experience with instrumentation (HPLC, GC, MS, NMR, UV-Vis), strong documentation and data-analysis skills, and the ability to collaborate with cross-functional teams (R&D, Quality, Manufacturing). Ideal candidates demonstrate practical knowledge of GLP/GMP, method development and validation, chemical synthesis and purification, and the capacity to translate experimental findings into actionable recommendations.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Laboratory Technician or Research Assistant with hands-on bench experience and basic instrument operation.
  • Recent graduate with a B.S. or M.S. in Chemistry, Analytical Chemistry, or a closely related field.
  • Quality Control Associate or Process Technician transitioning into analytical roles.

Advancement To:

  • Senior Chemist / Lead Chemist
  • R&D Scientist or Analytical Development Scientist
  • Manager, Analytical Development or Quality Control Manager

Lateral Moves:

  • Quality Control Specialist or QA Specialist
  • Process Development Engineer
  • Regulatory Affairs Associate

Core Responsibilities

Primary Functions

  • Design, plan, and execute chemical experiments and analytical procedures to support R&D initiatives, process development, and product quality investigations, ensuring reproducibility and scientific rigor.
  • Develop, optimize, and implement analytical methods (HPLC, GC, GC-MS, LC-MS, UV-Vis, titration, FTIR) for qualitative and quantitative analysis of raw materials, intermediates, and finished products.
  • Perform method validation, verification, and transfer activities according to ICH, USP, ASTM, or internal standards, including accuracy, precision, linearity, LOD/LOQ, specificity, and robustness testing.
  • Conduct routine and non-routine sample testing under GLP/GMP/ISO conditions; generate complete, defensible analytical data sets and interpret results for decision-making.
  • Operate, calibrate, and troubleshoot laboratory instrumentation (HPLC, GC, mass spectrometers, spectrophotometers, Karl Fischer titrators, pH meters), ensuring instrument qualification and reliable performance.
  • Synthesize, isolate, and purify small molecules or intermediates using classical wet chemistry and modern synthetic techniques, and characterize products by NMR, MS, melting point, and elemental analysis.
  • Lead stability studies and degradation profiling, preparing stability protocols, analyzing time-point samples, and summarizing results for regulatory submissions or product lifecycle management.
  • Prepare clear, accurate technical reports, lab notebooks, SOPs, batch records, and validation documents; maintain meticulous documentation to support audits and regulatory reviews.
  • Investigate out-of-specification (OOS) or out-of-trend (OOT) results: perform root cause analysis, corrective/preventive action (CAPA) recommendations, and implement follow-up testing and controls.
  • Collaborate cross-functionally with manufacturing, supply chain, regulatory affairs, and external vendors to support scale-up, technology transfers, and supplier quality investigations.
  • Manage reagent and sample inventory, prioritize sample flow, and coordinate with procurement to ensure uninterrupted lab operations and availability of critical consumables.
  • Execute and interpret advanced analytical characterizations (e.g., impurity profiling, degradation product identification, forced degradation studies) to define impurity profiles and support safety and efficacy assessments.
  • Support process optimization efforts by providing analytical input to reduce variability, improve yields, and enhance robustness of synthetic routes and purification strategies.
  • Mentor and train junior scientists, interns, and technicians on laboratory best practices, instrument operation, method procedures, safety protocols, and data integrity principles.
  • Implement and enforce laboratory safety programs, chemical hygiene plans, hazardous waste management, and PPE protocols to maintain a compliant and safe bench environment.
  • Participate in experimental design and statistical analysis (DOE, ANOVA, regression) to increase experiment efficiency and extract meaningful conclusions from data sets.
  • Prepare and present technical summaries and experimental results to stakeholders, project teams, and leadership; effectively translate complex analytical findings into actionable recommendations.
  • Support regulatory submissions by compiling analytical data, validation summaries, method descriptions, and supporting documentation required for dossiers (e.g., IND/NDA, MAAs).
  • Coordinate with external contract research organizations (CROs) and analytical service providers: draft test specifications, review data deliverables, and evaluate method transfer outcomes.
  • Perform environmental monitoring, contamination control, and maintain lab cleanliness standards; ensure instruments and consumables meet quality specifications.
  • Maintain and improve laboratory workflows, implementing continuous-improvement projects (LEAN, Six Sigma) to optimize throughput and reduce cycle time.
  • Execute sample preparation workflows (extraction, dilution, derivatization, filtration) with attention to traceability, chain-of-custody, and sample stability requirements.
  • Adhere to company policies and regulatory requirements by participating in internal and external audits and providing timely responses to audit findings.

Secondary Functions

  • Assist in procurement activities for specialized reagents, columns, and instrumentation; evaluate vendor quotes and manage vendor relationships for critical lab supplies.
  • Support cross-functional project teams by estimating analytical timelines, resource needs, and contributing to project plans and risk assessments.
  • Participate in internal audits and continuous improvement initiatives to strengthen laboratory quality systems and SOP adherence.
  • Help maintain instrument preventive maintenance schedules, coordinate service engineers, and track qualification/certification documentation.
  • Contribute to training materials, competency assessments, and onboarding programs for new laboratory staff.
  • Document and archive experimental data in electronic lab notebooks (ELN) or LIMS; ensure data integrity, backup, and long-term retrieval.
  • Support grant applications, technical proposals, and customer-facing technical queries by preparing method descriptions, capability summaries, and sample analyses.
  • Assist with hazardous waste disposal coordination, ensuring compliance with local, state, and federal regulations and company sustainability goals.

Required Skills & Competencies

Hard Skills (Technical)

  • HPLC / UHPLC method development, operation, validation, and troubleshooting for small molecules and complex matrices.
  • GC and GC-MS analysis expertise including sample introduction techniques, column selection, and spectral interpretation for volatile compounds.
  • LC-MS and high-resolution mass spectrometry experience for impurity identification, peptide mapping, and molecular weight confirmation.
  • Wet chemistry techniques: titration, reflux, extraction, recrystallization, distillation, and basic organic synthesis workflows.
  • Spectroscopic techniques: NMR interpretation (1H/13C), FTIR, UV-Vis, and Raman for structural elucidation and compound characterization.
  • Method validation and statistical analysis (precision, accuracy, linearity, robustness, system suitability) following ICH Q2(R1) and USP guidelines.
  • Experience with GLP, GMP, ISO 17025, or equivalent quality systems; writing and reviewing SOPs, protocols, and validation documentation.
  • Familiarity with electronic lab notebooks (ELN), laboratory information management systems (LIMS), and data integrity principles (ALCOA+).
  • Instrument qualification and preventive maintenance: IQ/OQ/PQ practices and troubleshooting of analytical instrumentation.
  • Sample preparation techniques for challenging matrices (solid, semisolid, biological fluids) including extraction, filtration, and concentration.
  • Chromatographic column selection, mobile phase preparation, gradient optimization, and detection method selection for complex separations.
  • Stability testing design and forced-degradation analysis to support shelf-life assignments and product development decisions.
  • Experience with DOE (Design of Experiments), statistics, and data visualization tools (e.g., JMP, Minitab, Python/pandas, Excel) for experimental optimization.
  • Knowledge of regulatory submission requirements and experience preparing analytical sections for technical dossiers.

Soft Skills

  • Exceptional attention to detail and commitment to accurate, reproducible laboratory records and documentation.
  • Strong analytical and problem-solving skills with the ability to interpret complex datasets and identify root causes.
  • Effective verbal and written communication skills for cross-functional collaboration, report writing, and presenting results to technical and non-technical audiences.
  • Time management and project prioritization skills to balance multiple experiments and meet critical project milestones.
  • Collaborative team player who contributes proactively to project teams and supports peers in a fast-paced R&D or QC environment.
  • Adaptability and willingness to learn new techniques, instruments, and software as technology evolves.
  • Integrity and ethical judgment in maintaining data integrity and regulatory compliance.
  • Initiative to identify process improvements and lead small-scale process or quality improvement projects.
  • Mentoring and coaching ability to develop junior staff and promote a culture of continuous learning.
  • Customer-focused mindset when interacting with internal stakeholders, external partners, and CROs.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor of Science (B.S.) in Chemistry, Analytical Chemistry, Chemical Engineering, Biochemistry, or closely related discipline.

Preferred Education:

  • Master of Science (M.S.) or Ph.D. in Chemistry, Analytical Chemistry, Organic Chemistry, or related field for senior or specialized roles.

Relevant Fields of Study:

  • Analytical Chemistry
  • Organic Chemistry
  • Physical Chemistry
  • Biochemistry
  • Chemical Engineering

Experience Requirements

Typical Experience Range:

  • 2–7 years of laboratory experience in analytical chemistry, quality control, or R&D environments.

Preferred:

  • 3+ years of hands-on experience with HPLC/GC/LC-MS and method development/validation, with demonstrated experience in GLP/GMP-regulated labs and cross-functional project contributions.
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