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. The Senior Program Manager, Sterile Compounding will lead the end-to-end product development and launch processes for sterile pharmaceutical products, ensuring compliance with regulatory standards and managing cross-functional teams effectively.

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&DAlign 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

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
• PMP or similar project management certification
• Experience working with compounding pharmacies or CDMOs focused on 503A/503B
• Familiarity with USP and cGMP standards
• Prior experience in launching new sterile injectable, ophthalmic, or topical dosage forms
• Experience with project portfolio tools (Smartsheet, Asana, etc.)