Analytical Chemist – III

Job Description

Job Summary:

• The main function of an Analytical Chemist is to conduct qualitative and quantitative analysis of chemical compounds to support research, product development, and quality control.
• A typical Analytical Chemist ensures the accuracy and reliability of data through method development, validation, and adherence to regulatory standards.
• Perform chemical analyses using techniques such as HPLC, GC, UV-Vis, FTIR, and titration/Develop, validate, and document analytical methods for raw materials, intermediates, and finished products Interpret data, prepare technical reports, and maintain accurate laboratory records/Ensure compliance with safety protocols, Good Laboratory Practices (GLP), and regulatory requirements (e.g., FDA, EPA).
• Troubleshoot instrumentation and analytical issues to maintain data integrity.
• Collaborate with cross-functional teams including R&D, QA/QC, and manufacturing.
• Participate in laboratory audits and support continuous improvement initiatives.

Duties & Responsibilities:

• Perform laboratory testing of:
• Raw materials.
• Drug substances.
• Drug products.
• In-process samples.
• Stability samples.
• Conduct routine wet chemistry and analytical testing using laboratory instrumentation, including:
• HPLC.
• GC.
• UV-Visible Spectroscopy.
• CGE.
• ICE.
• Polarimeter.
• Osmometer.
• pH Meter.
• Conductivity Meter.
• TOC Analyzer.
• Accurately document and review analytical results using electronic laboratory systems (LIMS).
• Follow all cGMP requirements, laboratory procedures, SOPs, and regulatory guidelines.
• Participate in peer review of data and laboratory documentation.
• Maintain laboratory equipment and ensure testing is performed according to approved methods.
• Support internal and external audits by maintaining thorough and compliant documentation.
• Complete required training in laboratory operations, safety procedures, and quality systems.

Required Qualifications:

• Bachelor’s or master’s degree in:
• Chemistry.
• Biochemistry.
• Pharmaceutical Sciences.
• Related scientific discipline.
• Minimum 5 years of experience in a GMP/cGMP Quality Control laboratory environment.
• Experience within the pharmaceutical or biopharmaceutical industry is required.
• Hands-on experience with analytical instrumentation such as HPLC, GC, and UV.
• Strong understanding of GMP documentation practices and regulatory compliance.
• Experience working with electronic laboratory systems and data management tools.
• Ability to follow detailed procedures and maintain a high level of accuracy.

Preferred Qualifications:

• 5-7 years of pharmaceutical QC laboratory experience.
• Experience using Empower chromatography software.
• Previous involvement in audit-ready environments.
• Experience reviewing laboratory documentation and SOPs.

Required Skills:

• Strong knowledge of analytical instrumentation and techniques Excellent problem-solving and critical thinking abilities Attention to detail and high standards for data accuracy Proficiency in laboratory software and Microsoft Office Suite Effective.
• communication and technical writing skills Ability to work independently and in a team-oriented environment.

Safety Requirements:

• This position supports testing activities involving high-potency oncology products.
• Candidates must be comfortable working in a controlled laboratory environment that requires:
• Strict adherence to safety procedures.
• Use of personal protective equipment (PPE).
• Use of respiratory protection when required.
• Compliance with OSHA and site-specific safety requirements.
• All necessary training and safety equipment will be provided.

Training:

• Comprehensive onboarding and GMP training provided.
• Initial training on SOPs, documentation systems, and laboratory procedures.
• Instrument-specific training based on assigned testing responsibilities.
• Employees are not expected to work independently until they have successfully completed training and demonstrated competency.

Work Environment:

• Primarily laboratory-based role.
• Electronic, paperless documentation environment utilizing LIMS.
• Combination of independent work and collaborative team support.
• Regular interaction with quality, compliance, and laboratory personnel.
• Candidates must demonstrate strong technical skills, GMP knowledge, attention to detail, and the ability to work effectively in a highly regulated pharmaceutical environment.

Education/Experience:

• Bachelors degree in Chemistry, Biochemistry, or a related field required; Masters or Ph.D.
• Preferred for advanced roles 5-7 years of experience in an analytical laboratory setting, preferably in pharmaceuticals, environmental science, or manufacturing.

Note:

• Quality Control Chemist supports a GMP-regulated Quality Control laboratory environment focused on pharmaceutical and biopharmaceutical products.
• This role involves performing routine analytical testing, documenting results in electronic systems, and supporting the release and stability testing of highly regulated products.
• The successful candidate will work in a collaborative team environment while maintaining compliance with cGMP requirements and established laboratory procedures.