Chemist

Job Title:

Chemist

Job Description

The Chemist plays a key role in a Quality Control (QC) laboratory, performing GMP-compliant testing and supporting commercial pharmaceutical manufacturing. This role focuses on raw material, in-process, and final product testing, method validation and transfer, routine monitoring, and continuous improvement activities such as LEAN and 5S. The Chemist ensures timely, accurate analytical results so that manufacturing operations proceed without interruption and serves as a technical resource within the department and across functions.

Responsibilities

+ Conduct procedure updates in the QC laboratory and perform GMP reviews of logbooks to ensure compliance and data integrity.

+ Coordinate waste management activities in the laboratory, supporting LEAN and 5S initiatives to maintain a safe, organized, and efficient work area.

+ Perform final product release testing, including all applicable analytical tests, to confirm product identity, purity, and quality prior to release.

+ Conduct raw material release testing as required to verify that incoming materials meet established specifications.

+ Perform testing, analyze data, and submit results in a timely manner so that commercial manufacturing activities are not delayed or impacted.

+ Execute laboratory method validation, transfer, and verification activities in accordance with pharmacopeial and regulatory requirements.

+ Coordinate routine monitoring and validation activities for laboratory methods, processes, and critical utilities.

+ Order laboratory supplies, assign expiry dates to incoming materials, track requisitions, and reconcile against received materials and invoices.

+ Perform chemistry testing of raw materials, in-process samples, final products, validation-related samples, and critical utility samples using appropriate analytical techniques.

+ Serve as a technical resource within the QC department and cross-functionally, providing expertise in analytical chemistry and pharmaceutical testing.

+ Participate in and may lead special projects related to method improvements, process optimization, or new product introductions.

+ Support investigations by analyzing data, identifying root causes, and contributing to corrective and preventive actions.

+ Prepare clear, accurate, and compliant reports and documentation related to testing, validation, and investigations.

+ Follow changes in pharmacopeial requirements (USP, BP, JP, EP) and support implementation and qualification of updated methods.

Essential Skills

+ 4+ years of relevant experience with a BS degree in Chemistry or an equivalent scientific discipline, or 2+ years of relevant experience with an MS degree.

+ Hands-on experience in analytical chemistry within a QC or pharmaceutical laboratory environment.

+ Prior experience in the pharmaceutical industry, with exposure to commercial manufacturing and QC testing.

+

Experience with biologics products; small and/or large molecule experience is preferred.

+ Working knowledge of GMPs and GLPs, including regulatory requirements for testing and validation in the pharmaceutical industry.

+ Strong understanding of chemistry techniques used to determine identity, purity, and quality of parenteral and solid dosage products.

+ Understanding of pharmacopeial requirements and the ability to follow, implement, and qualify changes to analytical methods.

+ Knowledge of USP, BP, JP, and EP requirements and change processes related to pharmaceutical testing.

+ Proficiency with analytical instruments and techniques such as HPLC, GC, UPLC, wet chemistry methods, CE (capillary electrophoresis), and SEC (size exclusion chromatography).

+ Investigation skills, including the ability to interpret data, identify trends, and support root cause analysis.

+ Strong report writing skills, with the ability to produce clear, accurate, and compliant documentation.

+ Good verbal, written, and interpersonal communication skills for effective collaboration with laboratory and cross-functional teams.

+ Proficiency in Microsoft Office applications and laboratory informatics tools such as LIMS and Empower.

Additional

Skills & Qualifications

+ Bachelor's or Master's…