4 дня назад
Senior Formulation Scientist
130 000 - 155 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Formulation Scientist (Sterile Injectables/Peptides): Develop and optimize sterile injectable products and peptide-based therapeutics from early feasibility through commercial scale-up and lifecycle management, with an accent on peptide stability, scalable formulation design, and regulatory compliance. Focus on designing stability programs, solving formulation and process-development challenges, and transferring robust products into commercial manufacturing.
Location: Los Alamitos, California, US; on-site
Salary: $130,000–$155,000 per year for US-based candidates, with the final range determined by location, experience, skills, training, licensure, and certifications.
Company
Hims & Hers is a public health and wellness platform delivering personalized access to diagnosis, treatment, and medication delivery.
What you will do
- Lead formulation and process development for sterile injectable and peptide-based products, including solutions, suspensions, and long-acting injectables.
- Design pre-formulation, excipient compatibility, forced-degradation, freeze-thaw, container-closure, and process-robustness studies.
- Develop stability programs and beyond-use-date justifications aligned with ICH Q1A(R2), Q5C, USP, and FDA 503B requirements.
- Provide technical input on peptide API selection, characterization, and make-versus-buy evaluations.
- Support technology transfer from laboratory and pilot scale to commercial manufacturing across sites.
- Author technical documentation, support OOS/OOT investigations and CAPA implementation, and mentor formulation scientists and technicians.
Requirements
- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field with 6–8+ years of industry experience, or a B.S./M.S. with 8–10+ years of relevant experience.
- Hands-on experience formulating peptide therapeutics for parenteral administration and developing sterile injectable drug products.
- Experience with formulation design, fill/finish considerations, container-closure selection, and scale-up in CGMP environments.
- Strong knowledge of peptide degradation pathways, stability-indicating analytical methods, and analytical data interpretation using UPLC/HPLC and mass spectrometry.
- Experience with ICH Q1A(R2)/Q5C stability studies, USP/FDA 503B requirements, technical writing, and cross-functional communication.
- Ability to work on-site in Los Alamitos, California.
Nice to have
- Experience with third-party API/BUD data packages and make-versus-buy sourcing recommendations.
- Familiarity with long-acting injectable or novel peptide delivery technologies.
- Experience with IND/NDA or 503B regulatory submissions.
- Prior leadership or mentorship experience and multi-site technology transfer coordination.
Culture & Benefits
- Competitive salary and equity compensation for full-time roles.
- Unlimited PTO, company holidays, and quarterly mental health days.
- Medical, dental, vision, and parental leave benefits.
- Employee Stock Purchase Program and 401(k) with employer matching.
- Offsite team retreats and a workplace focused on ethics, wellness, belonging, and diverse perspectives.
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