Senior Program Manager, Sterile Compounding (PMO)

📋 Description • As a Senior Program Manager, Sterile Compounding at Hims & Hers, you will be at the forefront of revolutionizing healthcare by leading the end-to-end product development and launch processes for critical sterile pharmaceutical products and facilities. This pivotal role is instrumental in Hims & Hers' mission to make personalized healthcare accessible and effective, ensuring that innovative treatments reach patients efficiently and with the highest quality standards. You will be a key driver in expanding our capabilities, supporting both 503A and 503B sterile compounding operations, and contributing directly to the company's growth and impact in the health and wellness sector. • Your day-to-day responsibilities will encompass the comprehensive management of cross-functional project teams throughout the entire product development lifecycle, from initial ideation and research and development (R&D) through to successful commercial launch. This includes leading critical workstreams focused on capacity expansion and continuous improvement initiatives that are vital for the sustained success of our 503A and 503B sterile product development efforts. You will be responsible for meticulously building and maintaining integrated project plans, ensuring all key milestones are met, timelines are adhered to, resource requirements are accurately forecasted, and potential risks are identified with robust mitigation strategies in place. A significant part of your role will involve preparing and delivering clear, concise program updates to senior leadership and key stakeholders, effectively communicating progress, highlighting any emerging risks, and outlining proposed mitigation strategies. You will also maintain comprehensive project documentation, strictly adhering to internal procedures and all relevant regulatory requirements, ensuring a high level of compliance and audit readiness. Furthermore, you will actively drive decision-making processes, facilitate productive team meetings, and serve as the primary point of contact for all project-related activities, ensuring seamless communication and coordination across all involved parties. A crucial aspect of your role will be to diligently track budgets and manage resource allocation across multiple, simultaneous product development initiatives, ensuring fiscal responsibility and optimal utilization of resources. • You will take full ownership of the New Product Introduction (NPI) process for all sterile compounded products, ensuring strict compliance with both 503A & 503B regulations and our stringent internal quality standards. This involves close collaboration with other PMO Project Managers and Subject Matter Expert (SME) Project Managers to guarantee that essential deliverables, such as packaging and marketing materials, are executed on schedule for successful launches. You will also play a key role in developing and optimizing NPI processes to adapt to our rapidly growing and evolving business landscape. In terms of R&D and Analytical Development Coordination, you will oversee due diligence activities, formula development, and the entire R&D process. This includes aligning closely with formulation scientists and analytical chemists on method development, sample testing, and accelerated stability studies. You will meticulously track R&D milestones, including pilot batches, formulation refinement, and compatibility testing, ensuring the timely execution of formulation, method development, process development, tech transfer, and equipment validation activities. Your partnership with the Quality team and Quality PMs will be essential to ensure proper alignment and execution throughout the project lifecycle. You will proactively document risks and develop mitigation plans to ensure adherence to necessary USP and cGMP compliance standards, and support the preparation of regulatory submissions and documentation, such as stability data, batch records, and validation protocols. • For New Facility Equipment Management, you will partner with R&D, Operations, Pharmacy, and Quality teams to oversee the critical steps required to launch new equipment within new spaces, supporting new technologies and/or product launches. This includes overseeing early-stage risk assessments, defining technical requirements, and documenting each phase of new equipment onboarding and training. You will also facilitate the creation and review of initial formulation drafts, product profiles, and compounding process flows. In Design Control & Product Definition, you will ensure the proper completion of design inputs, outputs, and verification/validation plans in accordance with quality system procedures, maintaining traceability matrices and supporting design reviews with stakeholders. You will also ensure the compatibility of components, containers/closures, and labeling/packaging. Regarding Facility & Equipment Qualification, you will ensure proper planning and execution of qualification activities for equipment and facilities used in compounding operations, collaborating with Engineering, Validation, and Quality teams to develop protocols, coordinate testing, and resolve deviations. You will also ensure proper management by SME PMs of timelines for design, qualification, and validation steps to align with production readiness for launch. Furthermore, you will ensure the proper creation and approval of Master Formulation Records (MFRs), Batch Production Records (BPRs), SOPs, and compounding instructions, coordinating quality reviews and ensuring documentation is audit-ready, and confirming alignment with 503A and 503B requirements and internal QMS processes. Finally, for Operational & Site Readiness, you will ensure all personnel are trained and facilities are prepped for production, including raw material sourcing, batch record training, and process simulations, collaborating with Supply Chain on procurement and inventory readiness, and partnering with tech teams for system readiness. You will also 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, and conduct post-launch reviews and continuous improvement feedback loops. You will also support PMO PMs and SME PMs in ongoing pharmaceutical operations continuous improvement initiatives. • This role offers a unique opportunity to significantly impact the growth and innovation within a leading health and wellness platform. You will gain invaluable experience in navigating complex regulatory environments, managing high-stakes product launches, and driving operational excellence in sterile pharmaceutical manufacturing. By successfully leading these initiatives, you will contribute to Hims & Hers' mission of making healthcare more accessible and effective, while developing your expertise in program management within a dynamic and fast-paced industry. You will have the chance to build and lead high-performing, remote and on-site teams, hone your skills in influencing without authority, and become a recognized leader in sterile compounding product development. 🎯 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. • 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.). 🏖️ 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.