Senior Formulation Scientist: Remote Sterile & Peptide

Socket.dev; Los Alamitos (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Competitive salary

Equity compensation

Unlimited PTO

Health benefits

ESPP

401k

Job summary

Hims & Hers is seeking a Senior Formulation Scientist to join the Sterile Product Development team, leading formulation strategy for sterile injectables and peptide therapeutics from early feasibility to scale-up.

You will collaborate with MS&T, Quality, and Regulatory to design robust, scalable formulations that meet CGMP and FDA 503B requirements, mentor scientists, and drive lifecycle management.

Qualifications

• Ph.D./M.S./B.S. with significant industry experience in sterile injectable product development.
• Hands-on experience formulating peptide therapeutics for parenteral administration.
• Demonstrated experience in sterile injectable product development, including fill/finish and container-closure.
• Strong understanding of peptide degradation pathways and stability-indicating analyses.
• Experience designing and executing stability studies per ICH Q1A(R2)/Q5C and USP/FDA 503B.
• Proficient in analytical data interpretation (UHPLC/LC-MS) and related peptide characterization methods.
• Experience with formulation scale-up and CGMP tech transfer.
• Excellent technical writing and cross-functional communication skills.

Responsibilities

• Lead formulation and process development for sterile injectable and peptide‑based products.
• Design pre‑formulation, excipient compatibility, and forced‑degradation studies for peptide stability.
• Develop stability programs aligned with ICH Q1A(R2)/Q5C and BUD justification.
• Provide input on peptide API selection and make-versus-buy evaluations.
• Plan lab- and pilot-scale studies to assess feasibility, freeze-thaw, and container‑closure compatibility.
• Publish technical reports, stability protocols, and development summaries for regulatory filings.
• Collaborate with MS&T, Quality, and Operations for technology transfer across sites.
• Support OOS/OOT investigations and CAPA implementations.
• Mentor formulation scientists and contribute to SOP development.
• Stay current on peptide delivery technologies and analytical advances.

Skills

Formulation development

Peptide formulation

Stability testing

Analytical methods

CGMP familiarity

Technical writing

Cross-functional collaboration

Education

Ph.D. in Pharmaceutical Sciences or related field

BS/MS with 8–10+ years in sterile injectable development

Tools

UPLC/HPLC

Mass spectrometry

Job description

Hims & Hers is seeking a Senior Formulation Scientist to join the Sterile Product Development team, leading formulation strategy for sterile injectables and peptide therapeutics from early feasibility to scale-up.

You will collaborate with MS&T, Quality, and Regulatory to design robust, scalable formulations that meet CGMP and FDA 503B requirements, mentor scientists, and drive lifecycle management.