Senior Project Manager
VetsEZ
PMP
Sr. Program Manager, Sterile NPI
hims & hers
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $125,000 - $150,000 per year
Job Level
Senior
Tech Stack
PMP
About the role
- 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.\n
- Lead say expansion and continuous improvement workstreams that support 503a and 503b sterile product development.\n
- Build and maintain integrated project plans including key milestones, timelines, resource requirements, risks, and mitigation plans.\n
- Prepare and present program updates to leadership and stakeholders, highlighting progress, risks, and mitigation strategies.\n
- Maintain project documentation in accordance with internal procedures and regulatory requirements.\n
- Drive decision-making, facilitate team meetings, and act as a key point of contact for all project-related activities.\n
- Track budgets and resource allocation across multiple simultaneous product development initiatives.\n
- 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.\n
- Work closely with PMO PMs and SME PMs to ensure key deliverables such as packaging and marketing are being executed in time for launch.\n
- Develop and optimize NPI processes for a growing & changing business.\n
- R&D and Analytical Development Coordination: Oversee due diligence, formula development, and R&D\n
- Align with formulation scientists and analytical chemists on method development, sample testing, and accelerated stability studies.\n
- Track R&D milestones including pilot batches, formulation refinement, and compatibility testing.\n
- Ensure timely execution of formulation, method development, process development, tech transfer, and equipment validation activities.\n
- Quality Partnership: Work closely with our Quality team & Quality PMs to ensure proper alignment and execution is followed throughout the project.\n
- Document risks and mitigation plans to align with necessary USP and cGMP compliance standards.\n
- Support regulatory submission preparation and documentation (e.g., stability data, batch records, validation protocols).\n
- 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.\n
- Oversee early-stage risk assessments, technical requirements, and documentation of each phase of new equipment onboarding & training.\n
- Facilitate the creation and review of initial formulation drafts, product profiles, and compounding process flows.\n
- Design Control & Product Definition: Ensure proper completion of design inputs, outputs, and verification/validation plans in accordance with quality system procedures.\n
- Maintain traceability matrices and support design reviews with stakeholders.\n
- Ensure compatibility of components, containers/closures, and labeling/packaging.\n
- Facility & Equipment Qualification: Ensure proper planning and execution of qualification activities for equipment and facilities used in compounding operations.\n
- Collaborate with Engineering, Validation, and Quality to ensure proper development of protocols, coordinate testing, and resolve deviations.\n
- Ensure proper management by SME PMs of timelines for design, qualification, and validation steps to align with production readiness for launch.\n
- Documentation & Quality Readiness: Ensure proper creation and approval of Master Formulation Records (MFRs), Batch Production Records (BPRs), SOPs, and compounding instructions.\n
- Coordinate quality reviews and ensure documentation is audit-ready.\n
- Ensure alignment with 503A and 503B requirements and internal QMS processes.\n
- Operational & Site Readiness: Ensure all personnel are trained and facilities are prepped for production — including raw material sourcing, batch record training, and process simulations.\n
- Collaborate with Supply Chain on raw material/component procurement and inventory readiness.\n
- Partner with tech teams for system readiness.\n
- Launch Planning & Commercial Handoff: Align with cross-functional teams on launch timing, go-to-market materials, and sales enablement.\n
- Track final release testing and readiness to fulfill initial prescriptions/orders.\n
- Conduct post-launch reviews and continuous improvement feedback loops.\n
- 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.
Requirements
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field\n
- 7+ years of project management experience in pharmaceutical or biotech product development; experience with sterile manufacturing required.\n
- Strong knowledge of 503A/503B regulatory frameworks and sterile compounding best practices.\n
- Proven experience managing formulation, process development, and tech transfer projects in a regulated environment.\n
- PMP or similar project management certification is preferred.\n
- Exceptional organizational, leadership, and communication skills.\n
- Ability to influence without authority and build relationships across functions and levels.\n
- Comfortable operating in a fast-paced, dynamic environment with shifting priorities.\n
- Experience working with compounding pharmacies or CDMOs focused on 503A/503B.\n
- Familiarity with USP <797>, <800>, <795>, and cGMP standards.\n
- Prior experience in launching new sterile injectable, ophthalmic, or topical dosage forms.\n
- Experience with project portfolio tools (Smartsheet, Asana, etc.).
