AR and D CHEMIST

PRIMARY PURPOSE: The Analytical Research & Development (AR&D) Chemist develops, transfers, and validates analytical methods to support raw material evaluation, product development, stability studies, and finished product testing at Formulated Solutions. This position uses analytical techniques including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Inductively Coupled Plasma (ICP), and Atomic Absorption (AA).

The AR&D Chemist ensures laboratory activities and documentation meet applicable current Good Manufacturing Practices (cGMP), Good Documentation Practices, compendial requirements, and approved procedures. This role also provides technical guidance and mentoring to Chemist I and Chemist II personnel and collaborates with Quality Control, Quality Assurance, Validation, and other subject matter experts to resolve analytical challenges.

MAJOR DUTIES AND RESPONSIBILITIES: Analytical Method Development, Transfer, and Validation Develop, optimize, transfer, and validate analytical methods for raw materials, in-process samples, finished products, and stability samples. Prepare, review, and revise analytical test methods, validation and transfer protocols, technical reports, and Standard Operating Procedures (SOPs).

Execute approved protocols, evaluate results against established acceptance criteria, and document conclusions and any deviations. Troubleshoot analytical methods, instrumentation, and testing issues in collaboration with internal subject matter experts, equipment vendors, and customers. Support cleaning validation activities through analytical testing and applicable method development and validation.

Laboratory Testing and Data Evaluation Perform testing using approved methods and applicable compendial procedures, including the United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP). Use analytical techniques and instrumentation such as HPLC, GC, ICP, AA, UV/Vis spectroscopy, infrared spectroscopy, pH, viscosity, and specific gravity.

Accurately record raw data and perform calculations, analysis, and interpretation of results. Maintain complete, accurate, and traceable laboratory records in accordance with data integrity requirements and Good Documentation Practices. Ensure testing is performed in accordance with applicable cGMP requirements, laboratory practices, SOPs, approved methods, and protocols.

Investigations and Quality Compliance Investigate out-of-specification (OOS) results and other laboratory discrepancies in collaboration with Quality Control and Quality Assurance. Support root cause analysis and the development, implementation, and documentation of corrective and preventive actions (CAPAs). Follow up on assigned investigations and CAPAs to support timely completion and verification of effectiveness.

Identify and escalate analytical concerns, unexpected results, and potential compliance issues. Support continuous improvement initiatives that strengthen laboratory reliability, efficiency, compliance, and customer satisfaction. Technical Collaboration and Mentoring Provide technical guidance, training, and mentoring to Chemist I and Chemist II personnel.

Collaborate with cross-functional teams to coordinate testing needs, resolve technical issues, and meet project timelines. Participate in customer discussions regarding analytical methods, testing requirements, investigations, and project updates, as needed. Communicate technical information and results clearly and professionally to internal and external stakeholders.

Laboratory Safety and Operations Maintain laboratory reagents and chemical inventories, including appropriate labeling, storage, expiration tracking, and access to current Safety Data Sheets (SDS). Follow requirements for personal protective equipment (PPE), chemical handling, waste collection, and disposal. Promote safe laboratory practices and cGMP compliance throughout the facility.

Perform other related duties as assigned by the Laboratory Manager or Vice President of Quality.

QUALIFICATIONS

Required Knowledge, Skills, and Abilities Demonstrated knowledge of analytical method development, transfer, and validation in an FDA-regulated laboratory environment. Strong working knowledge of cGMP, Good Documentation Practices, data integrity principles, and applicable laboratory procedures. Knowledge of compendial testing requirements, including USP, Ph.

Eur., and JP. Working knowledge of FDA requirements applicable to laboratory testing, documentation, and the generation of data supporting material and product disposition. Strong understanding of chemical composition, structure, properties, reactions, and interactions, including associated hazards and appropriate handling and disposal practices.

Knowledge of raw materials, manufacturing processes, and quality control principles. Proficiency in analytical instrumentation and techniques, including HPLC, GC, ICP, AA, UV/Vis, infrared spectroscopy, pH, viscosity, and specific gravity. Ability to troubleshoot analytical methods, instrument performance, and unexpected test results.

Experience preparing SOPs, analytical methods, protocols, and technical reports. Ability to analyze data, perform accurate calculations, interpret results, and communicate scientifically supported conclusions. Proficiency with computer applications and laboratory software used for data collection, analysis, documentation, and reporting.

Strong organizational skills and the ability to prioritize assignments, work independently, and adapt to changing project needs. Effective problem-solving skills and sound technical judgment. Strong written and verbal communication skills, including the ability to interact professionally with customers and cross-functional teams.

Ability to provide technical guidance and mentor laboratory personnel. Knowledge of chemical safety practices and appropriate protective equipment.

EDUCATION AND EXPERIENCE

Bachelor’s degree in Chemistry or a related scientific discipline. Minimum of three years of experience in an analytical laboratory within an FDA-regulated industry. Hands-on experience with analytical method development, transfer, and validation. Demonstrated experience working in a cGMP laboratory environment. PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT: Ability to lift and move laboratory supplies and materials weighing up to 15 pounds.

Work is performed in a laboratory environment with potential exposure to hazardous chemicals. Required to follow established safety procedures and wear appropriate PPE.