Job Title: Chemist

Job Description

This position involves conducting procedure updates in the QC lab and GMP reviews of logbooks. The chemist coordinates waste management, LEAN, and 5S efforts, performs final product release testing, and conducts raw material release testing as required. The role includes testing, analyzing, and submitting results to ensure commercial manufacturing activities are not impacted, as well as participating in laboratory method validation, transfer, and verification activities.

Responsibilities

• Coordinate routine monitoring and validation activities.
• Order supplies, assign expiry to incoming materials, track requisitions, and reconcile against incoming materials and invoices.
• Perform chemistry testing of raw material, in-process, final product, validation-related, and critical utility samples.
• Serve as a technical resource within the department and cross-functionally, potentially undertaking special projects.

Essential Skills

• Proficiency in wet chemistry and benchwork analytical chemistry testing, including HPLC and GC.
• Pharmaceutical industry experience with GMP, GDP.
• Biologics experience.
• Understanding of chemistry techniques required to determine identity, purity, and quality of parenteral and solid dosage products.

Additional Skills & Qualifications

• 4+ years of relevant experience and a BS degree in Chemistry or equivalent.
• 2+ years of relevant experience and an MS degree.
• Experience with Biologics Products.
• Working knowledge of GMPs, GLPs, pharmacopeial, and regulatory requirements for testing and validation in the pharmaceutical industry.
• Understanding of USP/BP/JP, EP the person, and the change process.
• Knowledge of CE, HPLC, GC, and UPLC systems.
• Investigation skills and report writing skills.
• Good verbal, written, and interpersonal communication skills.
• Proficiency in Microsoft Office, LIMS, and Empower applications.

Work Environment

This position is based onsite, Monday through Friday, with flexibility required to be on-call some weekends and to come in during off-shifts.