CHEMIST III

PRIMARY PURPOSE:

Chemist III serves as a senior member of the Analytical Laboratory team, providing technical expertise in analytical testing, method development, method validation, and laboratory investigations within a cGMP-regulated environment. This role is responsible for supporting laboratory operations through advanced analytical techniques including HPLC, Gas Chromatography (GC), Atomic Absorption (AA), and other instrumental methods.

Chemist III also serves as a technical mentor to junior laboratory personnel and plays a key role in ensuring compliance with FDA regulations, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and internal quality standards. The position requires strong problem-solving abilities, technical writing skills, and experience supporting validation and continuous improvement initiatives.

MAJOR DUTIES AND RESPONSIBILITIES:

Analytical Testing & Laboratory Operations

• Perform analytical testing of raw materials, in-process samples, stability samples, and finished products using validated laboratory methods.
• Operate, troubleshoot, and maintain analytical instrumentation including HPLC, GC, AA, FTIR, pH, viscosity, specific gravity, and other laboratory equipment.
• Accurately document, analyze, interpret, and report test results in accordance with GMP and data integrity requirements.
• Support laboratory investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and non-conforming results.

Method Development & Validation
• Lead analytical method development, method transfer, verification, and validation activities.

• Author and review validation protocols, reports, analytical test methods, and technical documentation.
• Execute method qualification and transfer studies to support new product introductions and customer projects.
• Ensure analytical methods comply with USP, FDA, ICH, and internal quality requirements.

Equipment Qualification & Compliance

• Support qualification, calibration, maintenance, and lifecycle management of laboratory equipment.
• Maintain compliance with GLP, GMP, FDA regulations, SOPs, and data integrity standards.
• Assist with laboratory readiness for customer audits, regulatory inspections, and internal quality audits.
• Participate in cleaning validation, process validation, and related quality initiatives as needed.

Leadership & Continuous Improvement

• Provide technical guidance, training, and mentoring to Chemist I and Chemist II team members.
• Support continuous improvement initiatives focused on laboratory efficiency, method robustness, compliance, and customer satisfaction.
• Promote a culture of safety, quality, accountability, and operational excellence throughout the laboratory.
• Collaborate cross-functionally with Quality Assurance, Validation, Manufacturing, Regulatory Affairs, and Research & Development teams.

Additional Responsibilities

• Maintain laboratory reagent inventories and ensure proper storage, handling, documentation, and disposal of chemicals.
• Ensure current Safety Data Sheets (SDS) and required PPE standards are maintained and followed.
• Perform other duties and special projects as assigned by laboratory leadership.

QUALIFICATIONS:

Required Qualifications

• Bachelor's degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific discipline
• Minimum of 4-5 years of analytical laboratory experience within an FDA-regulated pharmaceutical, medical device, cosmetic, or related manufacturing environment.
• Demonstrated experience with HPLC, GC, and other analytical instrumentation.
• Experience performing method validation, method transfer, and laboratory investigations.
• Strong knowledge of cGMP, GLP, GDP, USP, FDA regulations, and analytical laboratory best practices.
• Experience authoring technical documents including SOPs, validation protocols, reports, and test methods.
• Strong analytical, troubleshooting, and problem-solving skills.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Experience supporting CDMO, pharmaceutical, aerosol, topical, cosmetic, or personal care manufacturing environments.
• Experience with cleaning validation, process validation, and stability programs.
• Prior experience mentoring or training laboratory personnel.
• Familiarity with FDA, customer, and ISO audit environments.

EDUCATION AND TRAINING:

• Bachelor's degree in Chemistry or appropriate discipline.
• Must have four to five years experience working in an analytical laboratory in an FDA regulated industry.