Senior Scientist

Trident Consulting is seeking a " Sr. Scientist II, Biologics " for one of our clients in
"Aliso Viejo, CA " A global leader in business and technology services.





Role: Sr. Scientist II, Biologics

Location: Aliso Viejo, CA

Salary: $118K–$148K/year

Fulltime





Key Responsibilities


- Lead large-molecule analytical & bioanalytical development.
- Develop, validate, troubleshoot, and transfer analytical methods.
- Support stability studies, potency, purity, and data trending.
- Serve as Analytical Lead on CMC projects.
- Support QC, CRO/CMO activities, and regulatory submissions.
- Prepare technical reports and regulatory documentation.
- Provide scientific leadership and mentor junior scientists.






Must-Have Skills


- HPLC, UPLC, IEX-HPLC, SEC-HPLC, LC-MS
- CE, cIEF, MSD, ELISA
- ddPCR, qPCR, Octet, Biacore
- Method Development / Validation / Transfer
- Large-molecule analytical development
- Stability studies & trend analysis
- GxP / ICH / FDA
- CMC & regulatory submissions
- CRO/CMO experience






Education & Experience


- Ph.D. + 8 years OR M.S. + 10 years in Biochemistry, Analytical Chemistry, Immunoanalytical Chemistry, or related field.
- 6+ years pharmaceutical industry experience in large-molecule analytical development.