Pharmaceutical Analyst

Job Summary

Axelon is seeking a highly skilled Chemist I to join our team in a laboratory setting. As a key member of our team, you will be responsible for performing analyses, inspections, and testing of products, raw materials, and in-process materials.

Key Responsibilities

• Conduct qualitative and quantitative assays on samples to ensure quality standards and compliance with company standards, customer and governmental regulatory requirements, and product specifications.
• Utilize approved Test Methods, Protocols, Procedures (SOP's) and Corporate Policies while maintaining adherence to current industry standards.
• Employ a variety of analytical techniques, including standard analytical equipment and highly modern and automated instrumentation.
• Maintain and certify test instruments and apparatus to ensure compliance.
• May be involved or responsible for performing Laboratory Investigations, Change Controls, audit/review of laboratory data, implementing CAPA, Planning and scheduling laboratory activities, and coordinating process improvements.

Essential Duties and Functions

• Follow established laboratory safety procedures.
• Analyze samples using appropriate instrumentation (depending on training, some or all of the following would apply - HPLC, GC, UV, IR, KF, pH, etc.) while following current Methods & Procedures (SOP's).
• Process and report HPLC instrumental analysis using Empower data processing software.
• Process and report other instrumental analysis using the instrument specific data processing software.
• Document all activities in a legible manner following established formats and procedures.
• Identify and troubleshoot problems with instrumentation and analytical preparations.
• Initiate and conduct laboratory investigations.
• Review and approve analytical data.
• Participate in process improvement projects.
• Train new and current employees.

Qualification and Requirements

• BS/BA in Chemistry, or BS in a Related Science.

Experience Required

• Minimum 0 - 1 year in a pharmaceutical laboratory environment.

Specialized or Technical Knowledge, Licenses, Certifications required

• Must possess knowledge regarding various tests and wet chemistry techniques that pertain to Raw Material and/or Finished Product analyses (depending on assigned product line, some or all of the following would apply - Viscosity, Thin Layer Chromatography, various forms of 'Limit Tests', etc.).
• Knowledge of cGMP's.
• Knowledge of compendia procedures where applicable (i.e., USP, NF, BP, etc.).
• Possess good written and oral communication skills.
• Proficiency with Empower software and Microsoft Office- Word and Excel.
• Possess strong mathematical skills - fractions, percentages, ratios and algebraic expressions.
• Possess good problem-solving skills.

---