Senior Program Manager, Sterile Compounding (PMO)

Hims & Hers

9d • Remote

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• PMP or similar project management certification is preferred.
• 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.).

Responsibilities

• 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.
• 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.
• 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.
• 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).
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Support PMO PMs and SME PMs in initiatives as the needs of the business develop, such as pharmaceutical operations continuous improvement initiatives.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees