Wednesday - Saturday 4 ten hour days

Under the direction of a Chemistry Manager, the Analytical Chemist performs method development of UPLC potency assays for injectable drug products. The methods will be developed as stability-indicating, and, following validation, will be utilized for stability and QC testing. The analyst must be familiar with the workings of a GMP chemistry lab, equipment and documentation requirements, including following standard operating procedures, using proper documentation, performing forced degradation, method validation, preparing samples and analyzing results.

KEY RESPONSIBILITIES:

• Develop stability-indicating UPLC potency assays for small-molecule injectable drug products.
• Execute forced-degradation experiments in support of the method development.
• Become familiar with, and adhere to, requirements as documented in SOPs for Good Manufacturing Practices.
• Clearly document all laboratory activities using proper documentation.

ADDITIONAL RESPONSIBILITIES:

• Perform thorough peer reviews to ensure accuracy of raw data and calculations.

• Perform a variety of chemistry laboratory support activities, as assigned, such as routine cleaning and waste removal.

• Properly maintain work areas and supplies necessary to perform testing.

• Operate and maintain equipment per SOPs.

• Write or assist Manager with documenting quality related documents.

• Execute method validations for routine testing procedures.

• Occasionally perform weekend and Holiday duties if requested by Management.

• Develop teamwork and communication skills through active listening and honest dialog with fellow employees and management.

• Communicate effectively with internal personnel, as well as external customers.

• Participate in Chemistry department meetings and audits, as necessary.

• Other duties as assigned by management.

QUALIFICATIONS

Knowledge: Understanding of analytical chemistry techniques such as chromatography, reference standard handling, weighing, solution preparation and good laboratory documentation. Experience in a GMP laboratory with UPLC method development or ion chromatography is strongly preferred.

Skills: Ability to precisely follow written instructions, attention to detail, critical thinking, effective communication.

• Minimum Education: 4 year degree in Chemistry, life sciences, or related discipline.  MS in Analytical chemistry is very desirable.
• Minimum Laboratory Experience: 5-8 years of bench experience in an analytical chemistry laboratory. Experience with LC method development and validation are required.
• Able to communicate clearly and effectively, both orally and in writing to all levels of people inside and outside the company, including possessing good English speaking/writing skills, fluency and understandability.
• Must be able to successfully prioritize and manage multiple tasks and numerous projects in a fast-paced environment.
• Mathematical skills, including the ability to analyze scientific and test data, and a basic understanding of statistical analysis desirable.
• Able to review, compile, and analyze information to prepare reports.
• Goal oriented, with strong time management and organizational skills.