Pegasus Laboratories, Inc.

Pegasus Laboratories, Inc. is a full-service Contract Development and Manufacturing Organization, or CDMO, with a very special purpose: improving the lives of animals. Through our leading veterinary brand, PRN Pharmacal, we create trusted veterinary products that promote animal wellness, including behavior modification, urinary incontinence, and seizure management. Our team of professionals, including manufacturing, quality assurance, business development, scientists and chemists, regulatory experts, and veterinarians, offers the complete package, from idea through development and regulatory approval, to production and marketing.

Pegasus Labs, part of the PBI-Gordon Companies, Inc., is 100% employee-owned with more than 500 employee-owners, working together in pursuit of mutual success. We are growing – come join us!

The primary purpose of the Analytical Chemist, Raw Materials position is to provide new product development support for raw materials and packaging components. This role will serve as a subject matter expert for evaluation, test method development, and qualification of new raw materials and packaging components.

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  Responsible for the development and implementation of supporting documentation and testing of raw materials and packaging components to support new product approvals and launch.
• Coordinates with Formulations, Procurement, Quality, and the CMC teams to deliver a comprehensive material development and qualification package.
• Responsible for development and validation of analytical methods for raw materials.
• Designs, writes, and executes method validation protocols and reports in accordance with current industry standards as well as regulatory requirements, i.e. FDA, USP, EP.
• Coordinates analytical method transfer and training of raw material testing with the Quality Control Laboratory and serves as a technical resource for investigations.
• Responsible for developing new raw material specification documents and reviewing changes to existing raw materials to maintain established quality standards.
• Maintain raw material testing in accordance with cGMP, FDA, compendia standards.
• Must be able to analyze and review complex raw data and interpret results.
• All other duties as may be assigned

• Education: BS, MS, or PhD in Chemistry or a related field from an accredited university.
• Experience: 3+ years required with advanced degree, prefer 5+ with BS degree experience in pharmaceutical raw material testing and development, qualifications, and analytical method validations. Proficiency in analytical instrumentation and techniques such as HPLC, GC, UV-Vis, FTIR, KF, AA, Particle size, etc. Proficiency in raw material compendia wet chemistry techniques.
• Specialized knowledge or training: Must have a pharmaceutical, cGMP, background with an FDA regulated laboratory. Familiar with USP, EP, ICH, and VICH guidelines.
• Other Skills: Strong technical writing and documentation skills (cGMP, protocols, reports, OOS investigations, lab notebooks.