Senior Program Manager, Sterile Compounding (PMO)
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:
Hims & Hers is seeking a highly driven Senior Program Manager, Sterile Compounding to lead the end-to-end product development and launch processes for both (503B) (503A) sterile pharmaceutical products and facilities,. The ideal candidate will have deep experience in regulated environments, with a strong understanding of sterile manufacturing, product formulation, tech transfer, regulatory pathways, operational launch readiness, go-to-market readiness, and cross-functional collaboration. This role will drive projects from concept through R&D to launch, ensuring timelines, budgets, and quality standards are met. This role will support both the VP, Innovation and will be embedded within the fast-growing Operations & Innovation Program Management Office (PMO), reporting to the Director of Innovation Program Management (PMO).
This role will be responsible for managing teams remotely as well as on-site. This is a remote role with regular travel up to 25% of the time.
You Will:
Lead cross-functional project teams through the full product development lifecycle of 503a and 503b sterile product launches – from ideation through R&D to commercial launch.
Lead say expansion and continuous improvement workstreams that support 503a and 503b sterile product development.
Build and maintain integrated project plans including key milestones, timelines, resource requirements, risks, and mitigation plans.
Prepare and present program updates to leadership and stakeholders, highlighting progress, risks, and mitigation strategies.
Maintain project documentation in accordance with internal procedures and regulatory requirements.
Drive decision-making, facilitate team meetings, and act as a key point of contact for all project-related activities.
Track budgets and resource allocation across multiple simultaneous product development initiatives.
Roles & Responsibilities will include:
End-to-End NPI Ownership:
Lead all phases of new product introduction (NPI) for all sterile compounded products, ensuring compliance with 503A & 503B regulations and internal quality standards.
Work closely with PMO PMs and SME PMs to ensure key deliverables such as packaging and marketing are being executed in time for launch.
Develop and optimize NPI processes for a growing & changing business.
R&D and Analytical Development Coordination:
Oversee due diligence, formula development, and R&D
Align with formulation scientists and analytical chemists on method development, sample testing, and accelerated stability studies.
Track R&D milestones including pilot batches, formulation refinement, and compatibility testing.
Ensure timely execution of formulation, method development, process development, tech transfer, and equipment validation activities.
Quality Partnership
Work closely with our Quality team & Quality PMs to ensure proper alignment and execution is followed throughout the project.
Document risks and mitigation plans to align with necessary USP and cGMP compliance standards.
Support regulatory submission preparation and documentation (e.g., stability data, batch records, validation protocols).
New Facility Equipment Management:
Partner with R&D, Operations, Pharmacy, and Quality to oversee the steps required to launch new equipment within new spaces to support a new technology and/or product launch.
Oversee early-stage risk assessments, technical requirements, and documentation of each phase of new equipment onboarding & training.
Facilitate the creation and review of initial formulation drafts, product profiles, and compounding process flows.
Design Control & Product Definition:
Ensure proper completion of design inputs, outputs, and verification/validation plans in accordance with quality system procedures.
Maintain traceability matrices and support design reviews with stakeholders.
Ensure compatibility of components, containers/closures, and labeling/packaging.
Facility & Equipment Qualification:
Ensure proper planning and execution of qualification activities for equipment and facilities used in compounding operations.
Collaborate with Engineering, Validation, and Quality to ensure proper development of protocols, coordinate testing, and resolve deviations.
Ensure proper management by SME PMs of timelines for design, qualification, and validation steps to align with production readiness for launch.
Documentation & Quality Readiness:
Ensure proper creation and approval of Master Formulation Records (MFRs), Batch Production Records (BPRs), SOPs, and compounding instructions.
Coordinate quality reviews and ensure documentation is audit-ready.
Ensure alignment with 503A and 503B requirements and internal QMS processes.
Operational & Site Readiness:
Ensure all personnel are trained and facilities are prepped for production — including raw material sourcing, batch record training, and process simulations.
Collaborate with Supply Chain on raw material/component procurement and inventory readiness.
Partner with tech teams for system readiness.
Launch Planning & Commercial Handoff:
Align with cross-functional teams on launch timing, go-to-market materials, and sales enablement.
Track final release testing and readiness to fulfill initial prescriptions/orders.
Conduct post-launch reviews and continuous improvement feedback loops.
Continuous Improvement Workstreams:
Support PMO PMs and SME PMs in initiatives as the needs of the business develop, such as pharmaceutical operations continuous improvement initiatives.
You Have:
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field
7+ years of project management experience in pharmaceutical or biotech product development; experience with sterile manufacturing required.
Strong knowledge of 503A/503B regulatory frameworks and sterile compounding best practices.
Proven experience managing formulation, process development, and tech transfer projects in a regulated environment.
PMP or similar project management certification is preferred.
Exceptional organizational, leadership, and communication skills.
Ability to influence without authority and build relationships across functions and levels.
Comfortable operating in a fast-paced, dynamic environment with shifting priorities.
Experience working with compounding pharmacies or CDMOs focused on 503A/503B.
Familiarity with USP <797>, <800>, <795>, and cGMP standards.
Prior experience in launching new sterile injectable, ophthalmic, or topical dosage forms.
Experience with project portfolio tools (Smartsheet, Asana, etc.).
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. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
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.
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