Method Development Scientist
Greater Boston Area
Competitive Compensation/ Benefits Package
A CDMO in Greater Boston with more than 20 years of experience in chemical manufacturing is seeking a method development scientist to join their fast-paced team. They have developed deep expertise in custom NCEs, generic APIs, and custom manufactured fine chemicals. This client combines the responsiveness of a small company with the capacity and capabilities of a much larger one.
Responsibilities and Requirements:
- D. in Organic Chemistry or Analytical Chemistry required
- 0-4 years of industry experience
- Hands-on experience or knowledge of HPLC, GC, GC-MS among other analytical techniques
- Titration, FTIR, and other analytical techniques. for developing and product release of APIs.
- Contribute to development and optimization of methods for raw materials, IPC, final product, stability study, and cleanout samples, for API, and non-API products all under cGMP.
- Dynamic fast-paced, CDMO, cross functional, multi task working environment.
- Writing, executing protocols and validation analytical methods
- Effective coordination with customer for development, manufacture, release of product for new drug evaluations (NDEs) by supporting analytical aspects of project to meet project timelines.
- Working with stakeholders (Regulatory Affairs, EH&S, process chemists, process engineers) to optimize methods and process and to establish appropriate specification 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.
- Has hands-on experience or knowledge to operating LC/MS, and GC/MS.
This is an excellent opportunity to break into industry and be part of a collaborative team working on many projects. The scientist will "wear many hats" and have the opportunity to learn and grow from an established global company outsourcing with may different pharmaceutical and biotech companies. Apply today!