Senior Analytical Chemist

Job Title: Analytical Chemist - III

Job Location: Pearl River, NY

Job Duration: 6+ months

Hiring Manager 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.

Key Responsibilities

• Perform laboratory testing of:

o Raw materials

o Drug substances

o Drug products

o In-process samples

o Stability samples

• Conduct routine wet chemistry and analytical testing using laboratory instrumentation, including:

o HPLC

o GC

o UV-Visible Spectroscopy

o CGE

o ICE

o Polarimeter

o Osmometer

o pH Meter

o Conductivity Meter

o 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:

o Chemistry

o Biochemistry

o Pharmaceutical Sciences

o 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.

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.