Senior Scientist I Analytical Development (Biotech)

Location: South San Francisco, CA, United States; onsite. Fully remote applicants are not being considered.

Salary: $112,000–$135,000 USD annually

Company

hirify.global is a precision medicines company developing treatments intended to improve outcomes for patients with autoimmune diseases.

What you will do

• Support the development, validation, and transfer of analytical methods for starting materials, intermediates, drug substances, and drug products.
• Perform in-house analytical development for Phase 1 through late-stage drug development using UPLC/HPLC, LC-MS, Karl Fischer, and dissolution techniques.
• Review CMO/CTL in-process, release, and stability data, protocols, and reports.
• Trend stability and release data using statistical methods and assist with non-conformance investigations.
• Collaborate with the CMC team, QA, and external manufacturing and testing partners to generate and approve technical documents.
• Author technical reports and support CMC documentation for IND, IMPD, and/or NDA submissions.

Requirements

• BS or MS in chemistry or pharmaceutical sciences and 5+ years of analytical development experience.
• Experience with small-molecule drug and oral solid formulation analysis, including UPLC/HPLC, LC-MS, Karl Fischer, dissolution testing, IR, particle size analysis, and solid-state characterization.
• Experience working with CMOs and CTLs across early- to late-stage drug development.
• Knowledge of ICH, cGMP, quality, and regulatory requirements.
• Strong organizational, written, and verbal communication skills, with the ability to solve challenging analytical problems.
• Ability to work effectively in a fast-paced small-company environment and collaborate as a team member.

Culture & Benefits

• Collaborative, hardworking environment focused on improving patients' lives.
• Stock option grants and an annual bonus program.
• Health insurance premiums covered at 90% for employees and 80% for dependents.
• Unlimited PTO for exempt employees.
• Free onsite gym, stocked kitchen, Genentech Bus & Ferry Share access, and a $100 monthly cell phone stipend.