Seqens is an integrated global leader in pharmaceutical solutions and specialty ingredients, delivering outstanding performance, unrivalled market responsiveness and custom-made solutions to our customers. In keeping up with our rapid business expansion in North America region, we have following open position in our Analytical Services Department in Newburyport, MA:

Key responsibilities:

1.       Developing, validating, troubleshooting methods for raw materials, IPC, final product, stability study, and cleanout samples, for API, and non-API products all under cGMP.

2.       Writing, executing protocols and validation analytical methods to prove methods are suitable for intended use based on ICH and USP/EP requirements to support API lifecycle from early development to clinical stages and registration.

3.       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.

4.       Working with stakeholders (Regulatory Affairs, EH&S, process chemists, process engineers) to optimize methods and process and to establish appropriate specifications for raw material, in-process control and final release testing.

5.       Mentor junior scientists in the group and QC analysts to create a collaborative team environment, promote on-the-job learning to help junior scientists growing their careers.

6.       Advising junior scientists on phase appropriate analytical method considerations.

7.       Maintain lab notebook under cGMP guidelines.

8.       Writing lab SOPs, CCR, CAPA, QI, LIR, OOS, OOT, NL. 

Preferred qualifications:

1.       PhD in analytical chemistry with minimum 10 years of pharmaceutical experiences, preferably in CDMO setting.

2.       Working knowledge with USP procedures, ICH guidelines, and other regulatory guidelines.

3.       Hands-on experiences in the analysis of small molecule pharmaceutical API and/or ingredients

4.       Proficiency in operating analytical instrumentations, such as HPLC, LC/MS, GC, GC/MS, TOC, UV-vis, Particle size analyzer and wet chemistry under GMP guideline.

5.       Must enjoy the dynamic and fast-paced CDMO environment,

6.       A team player that cherishes the collaborative working relationship while maintaining individual accountability

7.       Ability of multitasking and prioritizing under stringent timeline

8.       Excellent communication abilities along with good document practices.