Under the direction of a Chemistry Manager, the Analytical Chemistry Analyst 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.
- 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.
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.
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.
Minimum Laboratory Experience: 2-5 years of bench experience in an analytical chemistry laboratory. Experience with LC method development is 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.
Able to review, compile, and analyze information to prepare reports.
Goal oriented, with strong time management and organizational skills.
Company Description SCA Pharmaceuticals is a rapidly growing company and nationwide leader in Outsourced Sterile IV Admixture products. Two sites, one based in Little Rock, AR and our new site in Windsor, CT!
Competitive Salaries and benefits in this rapidly growing company and industry.