Chemist

Job Title:

Analytical Chemist

Job Description

This role focuses on performing and supporting quality control laboratory activities within a regulated pharmaceutical environment. The chemist conducts analytical testing for raw materials, in-process samples, final products, validation-related samples, and critical utilities to ensure timely and compliant product release. The position also supports method validation and transfer, maintains laboratory documentation under GMP, and contributes to continuous improvement initiatives such as LEAN and 5S.

Responsibilities

* Conduct procedure updates in the quality control laboratory and perform GMP reviews of logbooks to ensure accurate and compliant documentation.

* Coordinate waste management activities in the laboratory in alignment with regulatory and internal safety requirements.

* Lead or support LEAN and 5S initiatives to maintain an efficient, organized, and safe laboratory environment.

* Perform final product release testing, including all applicable analytical tests, to ensure products meet specifications before release.

* Perform raw material release testing as required to verify the quality and suitability of materials for commercial manufacturing.

* Conduct testing and analysis of samples and submit results in a timely manner so that commercial manufacturing activities are not impacted.

* Support and perform laboratory method validation, transfer, and verification activities in accordance with regulatory and pharmacopeial requirements.

* Coordinate routine monitoring and validation activities to ensure ongoing compliance and control of laboratory systems and processes.

* Order laboratory supplies, assign expiry dates to incoming materials, track requisitions, and reconcile orders against incoming 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.

* Participate in or lead special projects as needed and serve as a technical resource within the department and across functions.

* Prepare clear and accurate test records, reports, and documentation in compliance with GMP, GLP, and data integrity requirements.

* Support investigations by providing analytical input, interpreting data, and contributing to written investigation reports as required.

Essential Skills

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

* Experience in the pharmaceutical industry, particularly in quality control or analytical chemistry.

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

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

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

* Ability to interpret and apply pharmacopeial requirements and to follow, implement, and qualify method changes.

* Understanding of USP, BP, JP, and EP requirements and the associated change processes.

* Hands-on knowledge of analytical techniques and systems such as capillary electrophoresis (CE), size exclusion chromatography (SEC), HPLC, GC, and UPLC.

* Proficiency in wet chemistry techniques and analytical chemistry methods.

* Investigation skills and the ability to contribute to root cause analysis and corrective actions.

* Strong report writing skills with the ability to clearly document methods, results, and conclusions.

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

* Proficiency with Microsoft Office applications for data analysis and reporting.

* Experience using LIMS and Empower or similar laboratory data management and chromatography systems.

* Demonstrated ability to work in a GMP-regulated laboratory environment with attention to detail and data integrity.

Additional

Skills & Qualifications

* Bachelor's degree in Chemistry or an equivalent scientific discipline; a Master's degree is an advantage.

* Prior experience in a pharmaceutical quality control laboratory supporting product release and validation activities.

* Familiarity with biologics analytical methods for both small and large molecules.

* Experience supporting LEAN and 5S initiatives in a laboratory setting.

* Ability to act as a technical resource and provide guidance to colleagues and cross-functional partners.

* Strong organizational skills to manage multiple tests, projects, and documentation requirements simultaneously.

* Comfort working with complex analytical instruments and troubleshooting basic instrument issues.

Work Environment

This is an onsite role with a standard schedule of Monday through Friday, 8:00 a.m. to 5:00 p.m. The position requires flexibility to be on-call on some weekends and to support off-shift testing when needed, which…