Sr. Project Manager, Sterile Compounding
Job Description
About the Role:
The Sr. Project Manager Sterile Compounding sits on the R&D-Operations Project Management team reporting to the Director of Innovation Program Management and is responsible for supporting all Hims & Hers sterile compounding launches from end-to-end. The goal of this role is to anticipate mitigate and navigate risk maintain clear internal communication across all related teams company-wide and keep all teams moving forward on schedule and on budget. The scope of this role will be broad and adaptive to support our teams and facilities as they grow. This is a senior level project management role that will both individually lead and also support other PMs in end-to-end product development and operations.
This role will be responsible for managing teams remotely as well as on-site. This is a remote role with regular travel (up to 50% of the time) to our compounding pharmacies located in Gilbert Arizona and Columbus Ohio.
You Will:
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Drive end-to-end sterile and injectable compounding launches (503a and 503b) through concept due diligence and formulation mapping ingredient sourcing R&D piloting quality and compliance testing machinery and tooling readiness pharmacy operations management and all necessary safety facility equipment and people management requirements for launch readiness.
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Support facility-related initiatives including process improvements space utilization cleaning protocols and operations R&D and scale-up processes and production optimizations.
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Lead pharmacy initiatives include pharmacy performance assessments staffing and operations assessments drug control services analytics implementation maintenance gap analysis training inventory optimization regulatory reviews and quality assurance.
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Be a subject matter expert for 503a and 503b sterile compounding process and facility requirements including FDA DEA and Boards of Pharmacy.
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Work cross-functionally across Legal Regulatory Quality & Compliance R&D Operations Marketing Medical and Supply Chain on a regular basis.
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Schedule and lead cross-functional meetings status calls and deliverable reviews regularly taking organized notes and sending meeting summaries.
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Manage each stage of the approval process and ensure proper alignment along the way.
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Act as the internal source of truth and main point of contact for assigned projects across the organization leading meetings and guiding teams through launch details as needed.
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Anticipate risks and solve for roadblocks proactively escalating appropriately.
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Prepare documentation and presentations to lead leadership and C-Suite updates.
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Work closely with our EMR Telemedicine and CX teams to create documentation that supports the organizational efforts required to train and support launch including the creation of educational decks and documents the leading of informational cross-functional meetings etc.
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Continuously follow up with team members to ensure the group remains on task to meet deadlines proactively escalating issues to minimize the risk and avoid delays.
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Strictly follow the defined PM processes and suggest workflow improvements as optimizations arise.
You Have:
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8+ years of project management experience in end to end product development supply chain and/or operations. Pharmaceutical experience is a plus.
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4+ years of sterile compounding project management in 503a and/or 503b facilities
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Experience operating within product-driven organizations with many stakeholders and with fast-moving programs
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Excellent verbal and written communication skills
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Experience managing various stakeholders and being flexible to different working styles
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Extreme attention to detail and documentation
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Strong leadership and relationship-building skills with an ability to quickly make decisions while remaining objective
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Can-do positive attitude that enjoys managing multiple projects and tasks simultaneously
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Curious and collaborative mindset with the ability to foster teamwork at all levels of the organization
Our Benefits (there are more but here are some highlights):
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Competitive salary & equity compensation for full-time roles
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Unlimited PTO company holidays and quarterly mental health days
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Comprehensive health benefits including medical dental & vision and parental leave
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Employee Stock Purchase Program (ESPP)
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Employee discounts on hims & hers & Apostrophe online products
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401k benefits with employer matching contribution
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Offsite team retreats
Conditions of Employment:
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This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves respiratory protection gown and other items as required.
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This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators including N95 full face respirator SCBA or Powered Air Purifying Respirator (PAPR).
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Physical exertion required. Including but not limited to walking up to 50% of the time standing up to 100% of the time squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
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Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity carcinogenicity and reproductive effects) of handling hazardous drugs.
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Date Posted
07/06/2024
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3
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