This company is an integrated global leader in pharmaceutical solutions and specialty ingredients, delivering outstanding performance, unrivaled market responsiveness, and custom-made solutions to our customers. In keeping up with our rapid business expansion in the North America region, we have the following open position in our Analytical Services Department in Newburyport, MA.
- Developing, validating, and troubleshooting methods for raw materials, IPC, final product, stability study, and cleanout samples, for API, and non-API products all under cGMP.
- Cherish dynamic fast-paced, CDMO, cross-functional, multitask working environment.
- Writing, and executing protocols, and validation analytical methods using mainly OpenLab, and GPC software to prove methods are suitable for an intended use based on ICH and USP/EP requirements to support API lifecycle from early development to clinical stages and registration.
- Effective coordination with customers for the development, manufacture, and release of products for new drug evaluations (NDEs) by supporting analytical aspects of the project to meet project timelines.
- Working with stakeholders (Regulatory Affairs, EH&S, process chemists, process engineers) to optimize methods and processes and to establish appropriate specifications for raw material in-process and final release testing.
- Writing lab SOPs, CCR, CAPA, QI, LIR, OOS, OOT, NL.
- Meeting timelines and delivering accurate results.
- Ph.D. in organic chemistry or analytical chemistry.
- Minimum 4 years of experience in method development/validation, all under cGMP
- Strong hands-on, multitasking, preferably from CDMO, and small molecules.
- Developing stability indicating methods for assay; purity, and residual solvents, and cleanout samples, utilizing, HPLC, GC, GPC, and other techniques.
- Working knowledge of USP procedures, ICH guidelines, and other regulatory guidelines.
- Hands-on experiences in the analysis of small molecule pharmaceutical API and/or ingredients
- Proficiency in operating analytical instrumentations, such as HPLC, LC/MS, GC (direct injection & HS), GC/MS, TOC, UV-vis, Particle size analyzer, titration, FTIR, and other analytical techniques for developing and product release of APIs.
- Wet chemistry under GMP guidelines.
- Must enjoy the dynamic and fast-paced CDMO environment,
- A team player that cherishes the collaborative working relationship while maintaining individual accountability
- The ability of multitasking and prioritize under the stringent timeline
- Excellent communication abilities along with good document practices.