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Key Responsibilities and Required Skills for Analytical Development Chemist

💰 $ - $

Analytical ChemistryPharmaceutical DevelopmentR&D

🎯 Role Definition

The Analytical Development Chemist is an early- to mid-career scientific professional responsible for designing, developing, validating, and transferring robust analytical methods to support drug substance and drug product development. This role centers on chromatographic and spectroscopic techniques (HPLC/UPLC, LC-MS, GC, UV-Vis), stability and forced degradation studies, impurity profiling, and producing high-quality analytical documentation in compliance with GMP/GLP and ICH guidelines. The ideal candidate is methodical, detail-oriented, experienced with ICH Q2(R1) method validation, and comfortable working in cross-functional teams (Formulation, Process Development, Quality, Regulatory) to enable CMC submissions and product commercialization.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Analytical Chemist / QC Analyst with hands-on chromatographic experience
  • Research Associate in pharmaceutical or biotech analytical labs
  • Laboratory Technician with method development exposure

Advancement To:

  • Senior Analytical Development Chemist
  • Principal Scientist, Analytical Development
  • Analytical Development Team Lead / Manager
  • Head of Analytical Development / CMC Analytical Leader

Lateral Moves:

  • Formulation Scientist
  • Process Development Chemist
  • Quality Assurance (Analytical Release) Specialist

Core Responsibilities

Primary Functions

  • Lead the design, execution and optimization of analytical method development projects for drug substance and drug product using HPLC/UPLC, LC-MS, GC, and related techniques, ensuring methods meet sensitivity, selectivity, accuracy, and robustness requirements for regulatory submission.
  • Plan and perform comprehensive method validation (accuracy, precision, specificity, linearity, range, LOD/LOQ, robustness) in accordance with ICH Q2(R1), preparing validation protocols, raw data, deviations, and final validation reports suitable for CMC dossiers.
  • Develop and execute forced degradation and stress testing studies (acid, base, oxidative, thermal, photolytic) to characterize drug substance/product degradation pathways and support impurity identification and specification setting.
  • Design and manage stability study sample testing and trending (long-term, accelerated, and ICH intermediate), interpret stability data, and contribute to shelf-life and storage condition recommendations for regulatory filings.
  • Conduct impurity profiling and identification using LC-MS/MS and HRMS workflows, including peak isolation strategies, mass spectral interpretation, and collaboration with structural elucidation teams to propose degradation or impurity structures.
  • Execute method transfer activities across internal labs and to contract testing organizations (CROs), prepare transfer protocols, perform comparative testing, troubleshoot discrepancies, and document acceptance criteria and final reports.
  • Create, review, and maintain analytical protocols, SOPs, batch records, method validation reports, analytical development reports, and CMC supporting documentation to ensure GMP/GLP compliance and audit readiness.
  • Develop and implement sample preparation procedures, extraction methods, and stabilization techniques for complex matrices (formulations, biological matrices, drug-device combinations) to ensure accurate analyte recovery and reproducibility.
  • Apply statistical tools and design of experiments (DOE) to optimize chromatographic conditions, robustness parameters, and critical method attributes; interpret statistical outcomes to support method performance decisions.
  • Troubleshoot routine and complex analytical instrumentation issues (HPLC/UPLC systems, autosamplers, columns, detectors, LC-MS interfaces), coordinate service/maintenance, and implement preventive measures to minimize downtime.
  • Collaborate with cross-functional project teams (Formulation, Process Development, Manufacturing, Quality, Regulatory Affairs) to align analytical strategies with program timelines and support technical sections for IND/NDA/MAA submissions.
  • Mentor and train junior scientists and laboratory staff on analytical techniques, method execution, data integrity practices, and instrument operation to build internal capability and ensure consistent data quality.
  • Establish and maintain LIMS/ELN entries, manage sample inventory and chain-of-custody, and ensure data integrity, backup, and archival in compliance with 21 CFR Part 11 and company policies.
  • Support scale-up activities by evaluating analytical method suitability for high-throughput environments, developing shortened run-time methods, and implementing ruggedness studies for manufacturing release environments.
  • Perform assay development for potency, content uniformity, dissolution, and related drug product tests, including method development for UV-Vis, titration, and other wet-chemistry techniques where applicable.
  • Lead investigations and root-cause analysis for out-of-specification (OOS) and out-of-trend (OOT) results, draft investigation reports, implement corrective and preventive actions (CAPA), and present findings to quality and project stakeholders.
  • Keep current with regulatory expectations and industry best practices (ICH, USP, EP) and proactively recommend updates to analytical strategies, specifications, and method control strategies to support regulatory approvals.
  • Coordinate analytical work with external partners and CROs, prepare technical agreements and scopes of work, review external data packages, and ensure alignment with internal quality and regulatory standards.
  • Drive continuous improvement projects to increase laboratory productivity, reduce method runtimes, and improve accuracy and throughput by leveraging automation, sample preparation robotics, and analytical method simplification.
  • Participate in technical risk assessments, design control for combination products, and provide analytical input to support product design, manufacturing process changes, and lifecycle management decisions.
  • Prepare and present technical summaries, analytical reports, and data packages for internal reviews and regulatory submissions, clearly communicating scientific rationale, method performance, and data integrity considerations.

Secondary Functions

  • Support cross-functional development projects by providing timely analytical data to inform formulation, process development, and manufacturing decision-making.
  • Assist quality teams during internal and external audits by preparing requested documentation, responding to audit observations, and implementing remediation plans.
  • Contribute to laboratory safety programs by identifying analytical hazards, participating in risk assessments, and enforcing safe handling of chemicals and instruments.
  • Participate in project planning, provide realistic analytical timelines and resource estimates, and escalate risk factors to project managers to ensure on-time delivery.
  • Maintain up-to-date training records and competency assessments for analytical staff; help develop training materials and standard work for new methods.
  • Evaluate new analytical technologies and instruments, provide recommendations for capital purchases, and participate in vendor qualification and installation activities.

Required Skills & Competencies

Hard Skills (Technical)

  • HPLC/UPLC method development and troubleshooting for small molecules and/or biologics, including column selection, mobile phase optimization, gradient design, and system suitability.
  • LC-MS and MS/MS experience for impurity profiling, degradation product identification, and confirmation of molecular weight and fragmentation patterns.
  • Strong knowledge of ICH Q2(R1) method validation principles and hands-on experience preparing validation protocols and reports aligned with regulatory expectations.
  • Experience with GC methods for volatile impurities, residual solvents (headspace GC), and method development/validation for gas chromatography.
  • Practical skills in dissolution method development and USP apparatus use, including discriminating method design, sink conditions, and dissolution profiling for immediate and controlled release products.
  • Proficiency with wet chemistry assays (potency, titration, Karl Fischer moisture analysis) and solid and liquid sample preparation techniques.
  • Familiarity with LIMS, ELN, chromatography data systems (CDS) such as Empower, Chromeleon, or MassLynx, and data integrity/21 CFR Part 11 compliance.
  • Experience applying DOE, statistical analysis, and regression modeling to support robustness testing and method optimization (software such as JMP, Minitab, or Excel advanced functions).
  • Knowledge of GMP/GLP laboratory practices, documentation standards, CAPA/OOS investigation workflows, and regulatory submission requirements (CMC).
  • Hands-on experience with instrument qualification, preventive maintenance, calibration, and vendor interactions (PQ/OQ/IQ support).

Soft Skills

  • Strong written communication skills for preparation of clear, complete analytical protocols, validation reports, and regulatory documentation.
  • Excellent verbal communication and presentation skills for cross-functional teams, periodic project reviews, and external partner interactions.
  • Problem-solving mindset with demonstrated ability to perform root-cause analysis and deliver pragmatic corrective actions under project timelines.
  • Time management and project organization skills to prioritize multiple analytical workstreams and manage competing deadlines.
  • Collaborative team player who proactively partners with formulation, process development, quality, and regulatory colleagues to achieve program goals.
  • Attention to detail and commitment to data integrity, reproducibility, and scientific rigor.
  • Adaptability and willingness to learn new analytical techniques, instrumentation, and regulatory expectations.
  • Mentoring and training capability to build technical competency across the analytical team.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor of Science (BSc) in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related discipline.

Preferred Education:

  • Master of Science (MSc) or PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related field for advanced method development, impurity identification, or leadership roles.

Relevant Fields of Study:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Organic Chemistry
  • Chemical Engineering
  • Biochemistry (for biologics-focused roles)

Experience Requirements

Typical Experience Range:

  • 2–6 years of hands-on analytical method development and validation experience in pharmaceutical, biotech, or contract research organizations.

Preferred:

  • 3–8 years of progressive experience with documented success in HPLC/LC-MS method development, stability testing, impurity profiling, and preparation of CMC documentation for regulatory filings. Experience with GMP lab operations and method transfer to CROs is highly desirable.
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