Scientist, Analytical Stability (On-Site)
Our large biotech client is looking for someone to join their fast-growing team. This position requires a highly qualified and dedicated applicant who will work on the analytical team.
The Scientist of the Analytical Stability Group will be responsible for:
- Organize stability testing programs for development and clinical/commercial programs.
- Prepare stability plan with the team and all stakeholders.
- Contribute to designing and analyzing data obtained from studies such as stress and forced degradation, photostability, excursion management, in-use studies, and compatibility.
- Review stability SOPs and protocols to follow guidelines.
- Analyze trend stability data and specifications.
- Author and contribute analytical data to stability sections of regulatory submissions.
The ideal Scientist, Analytical Stability candidate will have:
- MS or PhD (preferred) in Chemistry, Biochemistry, Pharmacology, or a related field with 3-5 years of work experience with stability related functions such as QC or GMP.
- Extensive experience in working with HPLC and physico-chemical test methods or oligonucleotides or oligosaccharides or proteins.
- Prior experience working at a multi-site company or with a CMO is a plus
- Involved with material specification setting and justification is a plus
- A true team player and experience working wit a team
- Good communication skills