Senior Sterile & Peptide Formulation Scientist (Remote)

hims & hers; Los Alamitos (CA); On-site; USD 190,000 - 240,000; Full time

Benefits offered by this job

Competitive salary

Unlimited PTO

Health benefits

ESPP

401k matching

Offsite team retreats

Job summary

Hims & Hers is seeking a Senior Formulation Scientist to lead sterile injectable and peptide formulation development within the SPD team, guiding programs from early feasibility through commercial scale-up. You will collaborate across MS&T, Quality, and Regulatory to design robust formulations that meet CGMP and FDA 503B requirements, with mentorship responsibilities and opportunities to shape strategy.

The role emphasizes peptide formulation expertise, process development, and cross-functional

Qualifications

• PhD with 6-8+ years in sterile injectable product development or BS/MS with 8-10+ years experience.
• Hands-on peptide formulation for parenteral administration.
• Proven sterile injectable product formulation experience including fill/finish and container-closure.
• Strong understanding of peptide degradation pathways and stability-indicating methods.
• Experience designing stability studies per ICH Q1A(R2)/Q5C and USP/FDA 503B.
• Proficiency in analytical data interpretation (UPLC/HPLC, MS, impurity profiling).
• Experience with formulation scale-up and CGMP technology transfer.
• Excellent technical writing and cross-functional communication skills.

Responsibilities

• Lead formulation and process development for sterile injectable and peptide-based products.
• Design and execute pre-formulation, excipient compatibility, and forced-degradation studies for peptide stability.
• Develop stability programs aligned with ICH Q1A(R2) and Q5C; justify BUD for compounded/sterile products.
• Provide input into peptide API selection and make-vs-buy evaluations with stakeholders.
• Design lab- and pilot-scale studies for formulation feasibility and process robustness.
• Author and review technical reports, stability protocols, and development summaries for regulatory filings.
• Ensure smooth technology transfer of sterile/peptide formulations across sites.
• Support OOS/OOT investigations and CAPA for peptide product stability and quality.
• Mentor formulation scientists and contribute to SOPs and gaps analyses.
• Stay updated on peptide delivery technologies and new analytical methods.

Skills

Peptide formulation

Sterile injectable

Analytical methods

Cross-functional collaboration

Stability studies

Documentation

Education

PhD in Pharmaceutical Sciences

BS/MS with 8-10+ years sterile peptide formulation experience

Tools

UPLC/HPLC

Mass spectrometry

Job description

Hims & Hers is seeking a Senior Formulation Scientist to lead sterile injectable and peptide formulation development within the SPD team, guiding programs from early feasibility through commercial scale-up. You will collaborate across MS&T, Quality, and Regulatory to design robust formulations that meet CGMP and FDA 503B requirements, with mentorship responsibilities and opportunities to shape strategy.

The role emphasizes peptide formulation expertise, process development, and cross-functional