Senior Formulation Scientist, Sterile & Peptide Product Development

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 the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

About the Role:

We're looking for a Senior Formulation Scientist to join our Sterile Product Development (SPD) team, supporting the development and optimization of both sterile injectable products and peptide-based therapeutics. In this role, you'll lead formulation strategy and process development across a diverse product portfolio, supporting programs from early feasibility through commercial scale-up and lifecycle management.

You’ll bring deep technical expertise in sterile injectable and peptide formulation development, working cross-functionally with Manufacturing Sciences & Technology (MS&T), Quality, and Regulatory teams to design robust, scalable formulations that meet CGMP and FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio.

You Will:

• Lead formulation and process development for sterile injectable and peptide-based products, including solutions, suspensions, and long-acting injectable formats.
• Design and execute pre-formulation, excipient compatibility, and forced-degradation studies specific to peptide stability, including oxidation, deamidation, aggregation, and hydrolysis pathways.
• Develop and optimize stability programs aligned with ICH Q1A(R2) and Q5C, including BUD (beyond-use date) justification for compounded and sterile products.
• Provide technical input into peptide API selection, characterization, and make-vs.-buy evaluations in partnership with cross-functional stakeholders.
• Design lab- and pilot-scale studies to assess formulation feasibility, freeze-thaw stability, container-closure compatibility, and process robustness.
• Author and review technical reports, stability protocols, and formulation development summaries to support regulatory filings and internal decision-making.
• Partner with MS&T, Quality, and Operations to ensure smooth technology transfer of sterile and peptide formulations from lab to commercial manufacturing across sites.
• Support OOS/OOT investigations and CAPA implementation related to sterile and peptide product stability and quality.
• Provide scientific mentorship to formulation scientists and technicians, and contribute to SOP development and gap analyses (e.g., ICH stability guideline alignment).
• Stay current on peptide delivery technologies, degradation science, and analytical methods, and evaluate new technologies for lifecycle management.

You Have:

• Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field with 6-8+ years of industry experience, or B.S./M.S. with 8-10+ years of experience in sterile injectable product development, including direct peptide formulation work.
• Hands-on experience formulating peptide therapeutics for parenteral administration (solutions, suspensions, or lyophilized products).
• Demonstrated experience developing sterile injectable (parenteral) drug products, with direct involvement in formulation design, fill/finish considerations, and container-closure selection.
• Strong understanding of peptide-specific degradation pathways and stability-indicating analytical methods.
• Experience designing and executing stability studies in accordance with ICH Q1A(R2)/Q5C and USP/FDA 503B requirements.
• Proficiency in analytical data interpretation (UPLC/HPLC, mass spectrometry, impurity profiling, and related peptide characterization methods).
• Experience with formulation scale-up and technology transfer within CGMP environments.
• Excellent technical writing, documentation, and cross-functional communication skills.

Preferred

• Experience evaluating third-party API/BUD data packages and providing technical recommendations as part of make-vs.-buy sourcing decisions.
• Familiarity with long-acting injectable or novel peptide delivery technologies.
• Experience with regulatory documentation and submissions (IND/NDA or 503B filings).
• Prior leadership or mentorship experience within a formulation or analytical team.
• Experience managing multi-site technology transfer (e.g., coordinating between development and manufacturing facilities).

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [e-mail] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

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