Sr. Scientist II, Biologics

Job Title: Sr. Scientist II, Biologics

Location: Aliso Viejo, CA - Onsite

Type: Fulltime - Direct Hire

Salary Range: $118,000 – $148,000 Annually

We are seeking an experienced Analytical Technologies Scientist to join the Applied Research team. This is a highly hands-on laboratory role focused on analytical method development, validation, and transfer for large molecule drug development programs from early clinical stages through commercialization.

The ideal candidate should have strong expertise in developing analytical methods for large molecules and experience working closely with cross-functional teams, CROs, and CDMOs. The role requires independent execution of experiments, troubleshooting technical challenges, and leading analytical activities while ensuring high-quality scientific outcomes.

Key Responsibilities:

• Develop, validate, and transfer analytical and bioassay methods for large molecule products

• Execute laboratory experiments and independently troubleshoot analytical challenges

• Support stability studies, trend analysis, and product characterization activities

• Act as Analytical Lead on CMC projects and collaborate with internal teams and external partners

• Prepare technical reports and support regulatory documentation and submissions

• Support QC activities including method validation and transfer

Required Skills:

• Strong experience in analytical method development for large molecules

• Hands-on expertise with HPLC, UPLC, LC-MS, ELISA, qPCR, SEC-HPLC, and related analytical techniques

• Experience working with CROs/CDMOs

• Strong communication, collaboration, and project management skills

Qualifications:

Ph.D. with 8+ years or M.S. with 10+ years in Biochemistry, Analytical Chemistry, or related scientific fields with pharmaceutical industry experience in large molecule analytical development.