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Key Responsibilities and Required Skills for Analytical Scientist

💰 $ - $

🎯 Role Definition

The Analytical Scientist is a laboratory-based professional responsible for designing, developing, validating and executing analytical methods to support drug discovery, formulation development, clinical trials and commercial quality control. This role requires strong hands-on experience with chromatographic and spectrometric techniques (HPLC, LC‑MS/MS, GC, UV/Vis, etc.), demonstrated knowledge of GLP/GMP/QC practices, and the ability to translate scientific data into robust reports and regulatory documentation. The ideal candidate partners cross-functionally with R&D, Process Development, Quality Assurance and Regulatory Affairs to ensure analytical readiness for product development and submissions.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Laboratory Technician / Analytical Technician
  • QC Analyst (Operator or Associate)
  • Research Associate in Analytical Development

Advancement To:

  • Senior Analytical Scientist / Lead Analytical Scientist
  • Principal Scientist, Analytical Development
  • Manager, Analytical Development or QC
  • Technical Specialist (e.g., Chromatography Specialist)

Lateral Moves:

  • Formulation Scientist
  • Process Development Scientist
  • Bioanalytical Scientist
  • Quality Control/Assurance Specialist

Core Responsibilities

Primary Functions

  • Design, develop and optimize robust analytical assays (HPLC, UPLC, LC‑MS/MS, GC, dissolution, UV/Vis, and other relevant techniques) for quantitation, impurity profiling, and stability-indicating methods across small molecules or biologics.
  • Plan and execute method validation and qualification activities in accordance with ICH Q2(R1), USP, EMA and FDA guidance, generating comprehensive validation reports that include accuracy, precision, specificity, linearity, range, LOD/LOQ and robustness.
  • Prepare, review and approve Standard Operating Procedures (SOPs), analytical protocols, and technical reports to support GLP/GMP compliance and audit readiness.
  • Perform routine and non-routine sample analysis for raw materials, in-process controls, finished products and stability samples, ensuring data integrity and adherence to chain‑of‑custody procedures.
  • Troubleshoot complex instrument issues (HPLC/UPLC systems, LC‑MS/MS, GC, autosamplers) and perform routine preventive maintenance, coordinating with vendors and service engineers when necessary.
  • Lead analytical method transfers between internal groups, contract testing organizations (CROs), and external partners, providing technical oversight to ensure equivalency and successful transfer documentation.
  • Design and execute forced degradation and stability-indicating studies to support formulation development, shelf‑life assignment, and regulatory submissions.
  • Interpret chromatographic and mass spectrometric data, perform peak identification and integration, and apply appropriate statistical tools to support conclusions and decision-making.
  • Generate and present clear, data-driven technical summaries and investigation reports for deviations, OOS (out‑of‑specification) events and CAPA (corrective and preventive action) activities.
  • Contribute scientific input and analytical data to regulatory submissions (IND, NDA, BLA, eCTD modules) and technical dossiers, collaborating with Regulatory Affairs to ensure format and content adequacy.
  • Implement and maintain quality control practices including calibration, instrument qualification (IQ/OQ/PQ), reagent and standard management, and environmental monitoring where applicable.
  • Apply quality-by-design (QbD) principles to analytical method development and lifecycle management to enhance robustness and reduce rework during scale-up and commercialization.
  • Mentor and train junior scientists, analysts and technicians on laboratory techniques, instrument operation, data analysis and good documentation practices.
  • Lead or actively participate in cross-functional project teams, manage project timelines, deliverables and risk, and communicate analytical strategy and progress to stakeholders.
  • Evaluate and recommend new analytical technologies, software (e.g., Empower, Chromeleon, MassLynx), and laboratory automation opportunities to improve throughput and data quality.
  • Maintain rigorous electronic or paper laboratory notebooks and data systems, ensuring full traceability of analytical decisions and adherence to 21 CFR Part 11 where applicable.
  • Conduct root cause analysis for assay failures or atypical results and implement corrective technical actions to restore acceptable analytical performance.
  • Oversee stability program execution including sample scheduling, data trending, specification maintenance and stability report preparation to support product lifecycle activities.
  • Coordinate with procurement and inventory teams to manage critical consumables, reference standards, and calibrants to avoid testing interruptions and control costs.
  • Ensure laboratory safety and compliance with institutional and regulatory biosafety, chemical safety and waste disposal policies, contributing to continuous improvement initiatives.

Secondary Functions

  • Support tech transfer and scale-up activities by providing analytical rationales, acceptance criteria and testing strategies to manufacturing and process development teams.
  • Assist in vendor evaluation and oversight of contract labs (CROs) including audit support, method qualification, and data review to ensure quality and contractual compliance.
  • Participate in continuous improvement programs (Lean/Six Sigma) to optimize laboratory workflows, reduce turnaround time, and improve cost-efficiency.
  • Contribute to patent filings, scientific publications and conference presentations by preparing supporting analytical data and methodological descriptions.
  • Maintain awareness of regulatory trends and industry best practices for analytical development and quality control to proactively adapt analytical strategies.
  • Support cross-training initiatives that broaden laboratory capabilities and increase team resilience during peak workloads or staff transitions.

Required Skills & Competencies

Hard Skills (Technical)

  • Expertise in chromatographic techniques: HPLC/UPLC method development, optimization and troubleshooting.
  • Proficient in mass spectrometry including LC‑MS/MS for quantitative and qualitative bioanalytical and small molecule applications.
  • Experience with gas chromatography (GC) and related detectors for volatile analysis when applicable.
  • Strong understanding of method validation and verification per ICH Q2(R1), USP and global regulatory expectations.
  • Hands‑on experience with chromatography data systems (CDS) such as Waters Empower, Thermo Chromeleon, Agilent OpenLab, or equivalent.
  • Familiar with instrument qualification and calibration (IQ/OQ/PQ), preventive maintenance and vendor management.
  • Competence in forced degradation, stability testing design and interpretation to support stability‑indicating methods.
  • Proficiency with electronic laboratory notebooks (ELN), LIMS, and data integrity principles including 21 CFR Part 11 compliance.
  • Solid analytical data processing and statistical skills, including use of Excel, JMP, Minitab or similar for regression, ANOVA and trend analysis.
  • Experience preparing technical reports and regulatory documentation for IND/NDA/BLA submissions and quality dossiers.
  • Practical knowledge of GLP and GMP environments and experience supporting audits and inspections.
  • Experience with sample preparation techniques: SPE, protein precipitation, dilution strategies, filtration, and sample concentration techniques.
  • Familiarity with dissolution testing, particulate analysis, and impurity profiling where relevant to product type.
  • Ability to implement QbD principles and lifecycle management for analytical methods.
  • Basic scripting or data analysis ability in Python, R, or similar is a plus for advanced data handling and automation.

Soft Skills

  • Strong analytical thinking with meticulous attention to detail and accuracy in data interpretation and reporting.
  • Clear written and verbal communication skills for cross-functional collaboration and for writing high-quality scientific documentation.
  • Project management aptitude: ability to prioritize tasks, manage timelines and deliver results in a matrix environment.
  • Problem-solving mindset with the ability to lead root cause investigations and implement effective corrective actions.
  • Team player who mentors and develops others while contributing independently to technical tasks.
  • Adaptability and willingness to learn new technologies, methods and regulatory expectations quickly.
  • Stakeholder management skills to present complex analytical findings to non-technical audiences and senior leadership.
  • Organizational skills and process orientation to maintain laboratory QA/QC standards and documentation rigor.
  • Ethical judgment and integrity in handling confidential data and regulatory commitments.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or related scientific discipline.

Preferred Education:

  • Master’s or PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry or related discipline with emphasis on analytical method development and validation.

Relevant Fields of Study:

  • Analytical Chemistry
  • Pharmaceutical Sciences
  • Biochemistry
  • Chemical Engineering (with analytical emphasis)
  • Biology or Bioanalytical Science (for biologics roles)

Experience Requirements

Typical Experience Range:

  • 2–5 years of hands-on analytical laboratory experience for mid-level Analytical Scientist roles; entry-level roles may accept 0–2 years with strong internships.

Preferred:

  • 3–7+ years experience in pharmaceutical, biotech or CRO laboratory environments with proven track record in method development, method validation, stability studies and regulatory submission support. Experience in GLP/GMP settings and with chromatographic and mass spectrometric platforms is highly desirable.
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