Torchora
Back to Home

Internal Chemist — Key Responsibilities and Required Skills

💰 $50,000 - $95,000

ChemistryAnalyticalQuality ControlLaboratoryR&D

🎯 Role Definition

The Internal Chemist is responsible for performing and overseeing analytical testing and laboratory workflows to ensure product quality, regulatory compliance, and continuous process improvement. This role combines hands-on wet chemistry and instrumentation (HPLC, GC, LC-MS, UV-Vis), robust documentation practices (SOPs, batch records), problem solving for out-of-specifications (OOS) events, and collaboration with R&D, manufacturing, and quality teams to support product release, stability programs, and technical investigations. The ideal candidate brings a safety-first mindset, meticulous record-keeping, and a results-oriented approach to method development, method validation, and routine QC testing in a cGMP or ISO-regulated environment.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Laboratory Technician / QC Technician transitioning to chemist-level analytical responsibilities
  • Chemistry Intern or Co-op with hands-on instrumentation exposure
  • Junior Analytical Chemist or Research Associate

Advancement To:

  • Senior Analytical Chemist
  • QC/Analytical Team Lead or Supervisor
  • Analytical Development Scientist or Manager of Analytical Services

Lateral Moves:

  • Process Chemist (scale-up and manufacturing support)
  • Formulation Scientist (product development)
  • Compliance or Quality Assurance Specialist

Core Responsibilities

Primary Functions

  • Develop, optimize, and document analytical methods (HPLC, GC, LC-MS, titration, UV-Vis) for identification, quantitation, and purity testing of raw materials, in-process samples, and finished products, ensuring methods are robust and transferable across laboratories.
  • Lead method validation and verification activities per ICH, USP, EP guidelines, generating full validation reports, acceptance criteria, system suitability protocols, and supporting regulatory submissions.
  • Execute routine and release testing for manufacturing lots, maintaining tight turnaround times while ensuring all results are accurate, traceable, and compliant with SOPs and cGMP documentation practices.
  • Investigate out-of-specification (OOS) and out-of-trend (OOT) results through structured root cause analysis, designing and executing follow-up testing, corrective actions, and preventative measures.
  • Design and manage stability study protocols, sample collection schedules, and data trending to support shelf-life claims and product expiration dating, producing clear stability reports and summaries.
  • Operate, maintain, and troubleshoot analytical instruments (HPLC pumps, autosamplers, GC systems, mass spectrometers, balances, pH meters), performing routine calibration, qualification (IQ/OQ/PQ) and documenting maintenance logs.
  • Prepare and standardize reagents, buffers, chromatographic mobile phases, and reference standards following SOPs, ensuring reagent quality, lot traceability, and proper storage conditions.
  • Maintain laboratory information management system (LIMS) entries, ensuring data integrity, correct sample tracking, electronic records, and secure retention of analytical raw data and final reports.
  • Draft, review, and revise Standard Operating Procedures (SOPs), test methods, work instructions, and batch records to reflect best practices and regulatory requirements.
  • Support cross-functional product development projects by providing analytical input, feasibility assessments, and data to guide formulation decisions, process changes, and scale-up activities.
  • Train and mentor junior staff and laboratory technicians on analytical methods, safety practices, documentation expectations, and instrument operation to build a high-performing QC team.
  • Ensure laboratory safety and environmental compliance by enforcing chemical hygiene plans, proper waste disposal, PPE use, and emergency procedures; maintain up-to-date MSDS and safety documentation.
  • Execute sample preparation workflows including extraction, dilution, filtration, and sample concentration with attention to preventing cross-contamination and preserving sample integrity.
  • Perform chromatography and spectral data interpretation, peak integration review, and verification to ensure accurate reporting; apply corrective integrations and document rationale when required.
  • Support vendor qualification and incoming materials testing by performing supplier-sourced raw material analysis, establishing acceptance criteria, and collaborating with procurement to resolve quality concerns.
  • Participate in internal and external audits, providing required data, laboratory records, and explanations for testing procedures; implement audit remediation plans and continuous improvement actions.
  • Apply statistical tools and trend analysis to assay data to monitor method performance, method robustness, and detect drifts or biases; recommend method revalidation when justified.
  • Manage laboratory inventory, ordering of consumables and standards, and ensure critical spare parts and calibration supplies are available to minimize downtime.
  • Contribute to cross-disciplinary technical reports and regulatory documentation, including Certificates of Analysis (CoAs), validation summaries, and stability study submissions.
  • Lead or participate in technical investigations and deviation management processes, documenting investigations, root causes, CAPAs, and verifying effectiveness of corrective actions.
  • Collaborate with manufacturing and supply chain teams to support release decisions, hold samples, disposition of non-conforming materials, and continuous process verification activities.

Secondary Functions

  • Support ad-hoc analytical projects such as forced degradation, impurity profiling, and forced oxidation/reduction studies to characterize product stability and degradation pathways.
  • Assist R&D and production teams by providing analytical feasibility studies, designing experiments to de-risk manufacturing changes, and offering measurement solutions for in-process control (IPC).
  • Contribute to the laboratory’s continuous improvement program by identifying efficiency gains, automation opportunities (autosamplers, sample preparation robots), and implementing lean lab practices.
  • Coordinate external laboratory testing, reference material procurement, and collaboration with contract testing organizations (CROs) to supplement internal capabilities.
  • Prepare concise technical summaries and present analytical findings to cross-functional stakeholders including Quality, R&D, and Manufacturing leadership.
  • Maintain and improve documentation quality for regulatory readiness, ensuring all entries are complete, dated, signed, and attributable under ALCOA+ principles for data integrity.
  • Participate in project teams for new product introductions, providing analytical risk assessments, test method transfer plans, and training materials to receiving sites.
  • Perform periodic reviews of test methods and SOPs to ensure continued relevance, technical currency, and regulatory alignment; propose retirements or consolidations where appropriate.
  • Support environmental, health, and safety initiatives by participating in laboratory safety committees, chemical inventory reconciliation, and spill response drills.
  • Contribute to the development of technical KPIs for the analytical lab such as on-time release percentage, method pass rates, and instrument uptime metrics.

Required Skills & Competencies

Hard Skills (Technical)

  • Proficient in HPLC method development and troubleshooting, including column selection, mobile phase optimization, gradient design, and system suitability criteria.
  • Hands-on experience with gas chromatography (GC) and GC-MS for volatile and semi-volatile analysis, including sample introduction techniques.
  • Experience with LC-MS or LC-MS/MS for trace-level quantitation and impurity identification, including mass spectral interpretation.
  • Strong knowledge of wet chemistry techniques (titration, pH measurement, gravimetric analysis) and sample preparation protocols.
  • Demonstrated competency in method validation and verification following ICH Q2(R1), USP <1225>, and related regulatory guidance.
  • Familiarity with laboratory instruments qualification (IQ/OQ/PQ), routine calibration, and preventive maintenance workflows.
  • Working knowledge of cGMP, GLP, ISO 17025 expectations, and regulatory documentation (SOPs, batch records, Certificates of Analysis).
  • Experience with LIMS, chromatography data systems (CDS) such as Empower, Chromeleon, ChemStation, or similar, and electronic lab notebooks (ELNs).
  • Ability to prepare and review technical reports, validation reports, SOPs, and regulatory submission documents with clear scientific rationale.
  • Competence in statistical analysis of analytical data, including system suitability trending, standard curve generation, and use of basic statistical tools (e.g., Excel, JMP, Minitab).
  • Familiarity with chemical safety practices, hazardous waste management, and MSDS/GHS labeling requirements.
  • Exposure to stability protocols, forced degradation studies, and impurity profiling for product characterization.

Soft Skills

  • Meticulous attention to detail and strong commitment to data integrity and reproducible results.
  • Excellent written and verbal communication skills for clear reporting, SOP writing, and cross-functional presentations.
  • Strong problem-solving and root cause analysis capabilities, with the ability to synthesize technical data into actionable conclusions.
  • Time management and prioritization skills to handle multiple analytical workloads and meet tight release schedules.
  • Collaborative team player who can work effectively with R&D, Quality, Manufacturing, and Supply Chain stakeholders.
  • Adaptability and continuous-learning mindset to stay current with analytical technologies, regulatory changes, and best practices.
  • Initiative and ownership for driving investigations to closure and implementing preventive improvements.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or a closely related field.

Preferred Education:

  • Master’s degree or PhD in Analytical Chemistry, Pharmaceutical Analysis, or a related discipline preferred for specialized method development and leadership roles.

Relevant Fields of Study:

  • Analytical Chemistry
  • Organic Chemistry
  • Pharmaceutical Sciences
  • Biochemistry
  • Chemical Engineering (with strong analytical focus)

Experience Requirements

Typical Experience Range:

  • 2–5 years of hands-on laboratory experience for mid-level Internal Chemist roles; entry-level may require 0–2 years with internship experience.

Preferred:

  • 3–7+ years of analytical laboratory experience in regulated environments (pharmaceutical, nutraceutical, chemical manufacturing, or analytical CRO), with demonstrable experience in HPLC/GC/LC-MS, method validation, and cGMP documentation.
Explore More Careers