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Key Responsibilities and Required Skills for Development Chemist

💰 $ - $

ChemistryResearch & DevelopmentPharmaceuticalFormulationAnalytical

🎯 Role Definition

The Development Chemist is responsible for designing, developing, and optimizing chemical formulations and processes for product development programs. This role includes hands-on laboratory work, analytical method development and validation, pilot-scale trials, process scale-up and technology transfer, and close collaboration with cross-functional teams (Manufacturing, Quality, Regulatory, Supply Chain, and Product Development) to ensure product performance, manufacturability, regulatory compliance, and cost efficiency. The ideal candidate brings a balance of experimental expertise, rigorous documentation practices, problem-solving capability, and familiarity with DOE/statistical analysis to accelerate product development timelines.

📈 Career Progression

Typical Career Path

Entry Point From:

  • R&D Technician or Laboratory Technician with hands-on chemistry experience
  • Analytical Chemist with method development background
  • Recent graduate with B.S./M.S. in Chemistry, Chemical Engineering or Pharmaceutical Sciences with internship/R&D experience

Advancement To:

  • Senior Development Chemist / Senior Formulation Scientist
  • Process Development Scientist / Team Lead
  • Principal Scientist, R&D Manager, or Technical Project Manager

Lateral Moves:

  • Quality Control / Assurance Chemist (QC/QA)
  • Manufacturing / Process Engineer
  • Regulatory Affairs Associate

Core Responsibilities

Primary Functions

  • Lead formulation design and development activities for new products and line extensions, creating robust, manufacturable formulations that meet performance specifications, stability targets and cost objectives.
  • Design, plan and execute lab-scale experiments and pilot plant trials to optimize formulation composition, process conditions and unit operations for reliable scale-up.
  • Develop, optimize and validate analytical methods (HPLC, GC, UV-Vis, FTIR, titration, dissolution, particle size, rheology) to support formulation characterization, stability studies and release testing.
  • Conduct forced degradation and accelerated stability studies and interpret analytical data to support shelf-life determination, packaging selection and storage recommendations.
  • Perform organic synthesis and intermediate preparation as required for product development, including purification, isolation and characterization of reaction products using NMR, MS and chromatography.
  • Execute design of experiments (DOE) and statistical analysis to identify critical process parameters (CPPs) and critical quality attributes (CQAs), and to drive robust process windows.
  • Prepare and maintain detailed laboratory notebooks, batch records and technical reports documenting experimental procedures, results, deviations and conclusions in compliance with cGMP/GLP and internal documentation standards.
  • Lead technology transfer packages for pilot, scale-up and commercial manufacturing, including process descriptions, SOPs, analytical methods, batch records and training materials for manufacturing and QA teams.
  • Troubleshoot process and formulation issues in collaboration with production, QA and engineering teams to resolve root causes, implement corrective actions and prevent recurrence.
  • Manage raw material selection and supplier qualification activities, including testing of alternative raw materials, supplier audits support and specification development to ensure consistent supply quality.
  • Collaborate with Regulatory Affairs to generate technical content for regulatory filings (e.g., CMC sections of regulatory submissions), stability summaries and support responses to agency inquiries.
  • Drive continuous improvement projects focused on yield enhancement, cost reduction, waste minimization, and process safety using lean, Six Sigma or similar methodologies.
  • Perform risk assessments (e.g., FMEA) for new processes and product introductions and implement mitigation strategies to ensure product quality and regulatory compliance.
  • Execute pilot-scale and scale-up manufacturing runs, collect process data, evaluate scale-up performance and translate learnings to commercial-scale operations.
  • Oversee sample management and chain-of-custody for development samples, ensuring traceability, correct storage and timely distribution for analytical and stability programs.
  • Mentor, train and supervise junior chemists and technicians in laboratory techniques, safety practices, documentation standards and experimental design to build team capability.
  • Coordinate cross-functional project teams, communicate technical progress to stakeholders, track milestones and deliverables, and escalate risks and resource needs as required.
  • Develop and update standard operating procedures (SOPs), master batch records, methods documentation and safety protocols to reflect best practices and regulatory requirements.
  • Conduct environmental, health and safety (EHS) risk assessments for new chemistries and processes, including hazard analysis, PPE selection and safe handling instructions for hazardous materials.
  • Evaluate and implement green chemistry principles where feasible to reduce solvent usage, hazardous reagents and environmental footprint while maintaining product performance.
  • Perform analytical data trending and interpretation for process capability studies, quality investigations and stability datasets to inform product lifecycle decisions.
  • Support cost modeling and raw material cost-benefit analysis to inform formulation choices and commercial pricing strategies.
  • Collaborate with procurement and supply chain to resolve supply disruptions, qualify alternative suppliers and maintain BOM accuracy for development lots and scale-up runs.
  • Drive intellectual property awareness by documenting innovative formulations, process improvements and experimental results that may support patent filings or trade-secret protection.
  • Participate in customer technical support meetings, provide technical input for product claims, and support troubleshooting for customer complaints related to formulation or product performance.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis.
  • Contribute to the organization's data strategy and roadmap.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.
  • Assist quality control during lot release testing and provide root-cause support for OOS/OOT investigations.
  • Support marketing and product management with technical material summaries, performance data and sample testing for customer trials and claims substantiation.
  • Participate in pilot plant commissioning, scale-up equipment qualification and vendor FAT/SAT activities as the technical subject matter expert.
  • Provide input for training modules and competency assessments for manufacturing operators and QA personnel specific to new formulations and processes.

Required Skills & Competencies

Hard Skills (Technical)

  • Formulation Development: experience designing liquid, semi-solid or solid dosage/product formulations and balancing performance, stability and manufacturability.
  • Analytical Method Development & Validation: proficiency in HPLC, GC, titrations, UV-Vis, dissolution, FTIR, and method validation per ICH/USP guidelines.
  • Chromatography & Spectroscopy: hands-on operation and data interpretation for HPLC, GC-MS, LC-MS, NMR and IR spectroscopy.
  • Process Scale-up & Technology Transfer: demonstrated success translating lab-scale processes to pilot/commercial manufacturing with complete transfer documentation.
  • Stability Testing & Shelf-Life Determination: planning, execution and interpretation of accelerated and long-term stability programs.
  • Organic Synthesis & Purification: practical experience with multi-step synthesis, reaction optimization, crystallization and purification techniques.
  • Design of Experiments (DOE) & Statistical Analysis: applied use of DOE, regression analysis and tools like JMP, Minitab, or R for process optimization.
  • cGMP/GLP Compliance & Documentation: strong knowledge of regulatory documentation, batch records, SOPs, and data integrity expectations.
  • Quality & Regulatory Familiarity: understanding of QA/QC processes, regulatory filing requirements (CMC), and support of regulatory submissions.
  • Laboratory Instrumentation: experience maintaining and qualifying lab equipment, including HPLC/GC systems, balances, pH meters and rheometers.
  • Pilot Plant Operations: familiarity with pilot-scale reactors, mixing equipment, transfer lines and scale-up considerations.
  • Safety & EHS: competency in hazard assessment, chemical safety, waste disposal protocols and PPE selection.
  • LIMS & ELN Systems: experience using Laboratory Information Management Systems and Electronic Lab Notebooks for sample tracking and documentation.
  • Supply Chain & Supplier Qualification: experience evaluating raw material suppliers, performing qualification testing and managing specifications.

Soft Skills

  • Strong problem-solving mindset with the ability to rapidly triage experiments, interpret complex data and recommend evidence-based solutions.
  • Excellent written communication for technical reports, regulatory documents and SOPs; strong presentation skills for cross-functional stakeholder updates.
  • Project management and prioritization skills to manage multiple R&D projects, timelines and resource constraints.
  • Collaborative team player who works effectively with manufacturing, QA, regulatory, procurement and external partners.
  • Attention to detail and commitment to data integrity and reproducible experimental documentation.
  • Initiative and adaptability to work in a fast-paced R&D environment with evolving technical requirements.
  • Mentoring and coaching ability to develop junior staff and promote laboratory best practices.
  • Strategic thinking with an ability to align technical work to commercial objectives and product roadmaps.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree (B.S.) in Chemistry, Analytical Chemistry, Chemical Engineering, Pharmaceutical Sciences, Materials Science, or closely related field.

Preferred Education:

  • Master’s (M.S.) or Doctorate (Ph.D.) in Chemistry, Formulation Science, Chemical Engineering or Pharmaceutical Sciences for senior roles or technically complex projects.

Relevant Fields of Study:

  • Organic and Analytical Chemistry
  • Chemical Engineering
  • Pharmaceutical Sciences
  • Materials Science and Polymer Chemistry
  • Physical Chemistry and Process Chemistry

Experience Requirements

Typical Experience Range:

  • 2–7 years of hands-on formulation, analytical method development or process development experience for mid-level roles.
  • 7+ years preferred for senior or technical lead positions with demonstrated scale-up and tech transfer experience.

Preferred:

  • 3–5+ years’ experience in product development within pharmaceutical, specialty chemicals, personal care, adhesives, coatings or related industries.
  • Demonstrated track record of successful pilot-scale runs and technology transfers to manufacturing.
  • Experience working under cGMP/GLP conditions, with familiarity in regulatory submission support (CMC).
  • Prior experience with DOE, statistical tools, and stability program design and interpretation.
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